A Safety Study of SEA-BCMA in Patients With Multiple Myeloma | NCT03582033 | Trialant
NCT03582033
Sponsor
Seagen Inc.
Status
Terminated
Last Update Posted
Dec 24, 2024Actual
Enrollment
83Actual
Phase
Phase 1
Conditions
Multiple Myeloma
Interventions
SEA-BCMA
dexamethasone
pomalidomide
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03582033
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
SGNBCMA-001
Secondary IDs
Not provided
Brief Title
A Safety Study of SEA-BCMA in Patients With Multiple Myeloma
Official Title
A Phase 1 Study of SEA-BCMA in Patients With Relapsed or Refractory Multiple Myeloma
Acronym
Not provided
Organization
Seagen Inc.INDUSTRY
Status Module
Record Verification Date
Oct 2024
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Study closed due to portfolio prioritization
Expanded Access Info
No
Start Date
Nov 1, 2018Actual
Primary Completion Date
Nov 9, 2023Actual
Completion Date
Nov 9, 2023Actual
First Submitted Date
Jun 12, 2018
First Submission Date that Met QC Criteria
Jul 3, 2018
First Posted Date
Jul 10, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Nov 1, 2024
Results First Submitted that Met QC Criteria
Nov 1, 2024
Results First Posted Date
Dec 24, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 1, 2024
Last Update Posted Date
Dec 24, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Seagen Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This trial will study SEA-BCMA to find out whether it is an effective treatment for multiple myeloma (MM) and what side effects (unwanted effects) may occur.
The study will have several parts. In Parts A and B, participants get SEA-BCMA by itself. This part of the study will find out how much SEA-BCMA should be given for treatment and how often. It will also find out how safe the treatment is and how well it works.
In Part C of the study, participants will get SEA-BCMA and dexamethasone. In Part D, participants will get SEA-BCMA, dexamethasone, and pomalidomide. Dexamethasone and pomalidomide are both drugs that can be used to treat multiple myeloma. These parts of the study will find out whether these drugs are safe when used together.
Detailed Description
Not provided
Conditions Module
Conditions
Multiple Myeloma
Keywords
RRMM
Antibodies, monoclonal
Antigens, BCMA
Immunotherapy
Hematologic diseases
Myeloma
Seattle Genetics
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
83Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Parts A and B: SEA-BCMA Monotherapy
Experimental
SEA-BCMA
Drug: SEA-BCMA
Part C: SEA-BCMA + Dexamethasone Combination Therapy
Experimental
SEA-BCMA + dexamethasone
Drug: SEA-BCMA
Drug: dexamethasone
Part D: SEA-BCMA + Pomalidomide + Dexamethasone Combination Therapy
Experimental
SEA-BCMA + dexamethasone + pomalidomide
Drug: SEA-BCMA
Drug: dexamethasone
Drug: pomalidomide
Interventions
Name
Type
Description
Arm Group Labels
Other Names
SEA-BCMA
Drug
Given into the vein (IV; intravenously)
Part C: SEA-BCMA + Dexamethasone Combination Therapy
Part D: SEA-BCMA + Pomalidomide + Dexamethasone Combination Therapy
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A
An adverse event (AE) was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of investigational product (IP). TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity & may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 44 months (maximum follow up of 45 months)
Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part B
An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity & may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 33 months (maximum follow up of 34 months)
Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part C
Secondary Outcomes
Measure
Description
Time Frame
Area Under the Serum Concentration-Time Curve From Time 0 to Day 14 (AUC0-14) of SEA-BCMA: Part A
Area under the observed concentration-time curve from the time of dosing to Day 14 calculated by log-linear trapezoidal approximation.
Cycle 1 and 2: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of MM
Must have MM that is relapsed or refractory
Has received a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody
Measurable disease, as defined by at least one of the following: (1) serum M protein 0.5 g/dL or higher, (2) urine M protein 200 mg/24 hour or higher, and (3) serum immunoglobulin free light chain (FLC) 10 mg/dL or higher and abnormal serum immunoglobulin kappa lambda FLC ratio.
Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1
Life expectancy of greater than 3 months in the opinion of the investigator
Adequate hematologic, renal, and hepatic function
Exclusion Criteria:
Parts A and D: Prior treatment with a BCMA-directed therapy
History of another malignancy within 3 years
Active cerebral or meningeal disease related to the underlying malignancy
Uncontrolled Grade 3 or higher infection
Prior antitumor therapy that is not completed at least 4 weeks prior to first dose of study drug, or at least 2 weeks if progressing. Prior CAR-T-cell therapy must be completed 8 weeks before first dose of study drug.
Combination therapy only:
Known intolerance to corticosteroids
Uncontrolled psychoses
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Jonathan Hayman, MD
Seagen Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Stanford University School of Medicine
Palo Alto
California
94304
United States
Rocky Mountain Cancer Centers - Aurora
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
This study had following parts: Part A (SEA-[B-cell maturation antigen] BCMA) monotherapy, Part B (SEA-BCMA monotherapy intensive dosing), Part C (SEA-BCMA and dexamethasone combination) and Part D (SEA-BCMA, pomalidomide and dexamethasone combination).
Recruitment Details
A total of 106 participants signed the informed consent form. 15 participants were screen failures, 8 were not assigned to receive study treatment and 83 participants received at least 1 dose of study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: SEA-BCMA 100mg
Participants received SEA-BCMA 100 milligrams (mg) as a monotherapy once every 2 weeks (q2wk) intravenous (IV) on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
FG001
Periods
Title
Milestones
Reasons Not Completed
Part A
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 3, 2022
Nov 1, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Parts A and B: SEA-BCMA Monotherapy
dexamethasone
Drug
Given by mouth (orally) or by IV
Part C: SEA-BCMA + Dexamethasone Combination Therapy
Part D: SEA-BCMA + Pomalidomide + Dexamethasone Combination Therapy
pomalidomide
Drug
Given orally
Part D: SEA-BCMA + Pomalidomide + Dexamethasone Combination Therapy
An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity & may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 36 months (maximum follow up of 37 months)
Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part D
An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity & may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 19 months (maximum follow up of 20 months)
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A
The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported.
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 44 months (maximum follow up of 45 months)
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part B
The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported.
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 33 months (maximum follow up of 34 months)
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part C
The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported.
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 36 months (maximum follow up of 37 months)
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part D
The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported.
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 19 months (maximum follow up of 20 months)
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A
The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 44 months (maximum follow up of 45 months)
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part B
The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 33 months (maximum follow up of 34 months)
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part C
The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 36 months (maximum follow up of 37 months)
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part D
The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 19 months (maximum follow up of 20 months)
Number of Participants With Dose Limiting Toxicities (DLTs): Part A
The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE >=Grade 3, unless deemed by the safety monitoring committee (SMC) to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death.
Cycle 1 (28 days)
Number of Participants With DLTs: Part B
The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE >=Grade 3, unless deemed by the SMC to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death.
Cycle 1 (28 days)
Number of Participants With DLTs: Part C
The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE >=Grade 3, unless deemed by the SMC to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death.
Cycle 1 (28 days)
Number of Participants With DLTs: Part D
The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE >=Grade 3, unless deemed by the SMC to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death.
Cycle 1 (28 days)
Area Under the Serum Concentration-Time Curve From Time 0 to Day 7 (AUC0-7) of SEA-BCMA: Part A
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1
AUC0-7 of SEA-BCMA: Part B
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1
AUC0-7 of SEA-BCMA: Part C
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1
AUC0-7 of SEA-BCMA: Part D
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1
Maximum Observed Serum Concentration (Cmax) of SEA-BCMA: Part A
Cycle 1 and 2: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 and 15
Cmax of SEA-BCMA: Part B
Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 and 15
Cmax of SEA-BCMA: Part C
Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 and 15
Cmax of SEA-BCMA: Part D
Cycle 1:Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 and 15
Number of Participants With SEA-BCMA Antitherapeutic Antibodies (ATA): Part A
A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.
Anytime during study (maximum up to 45 months)
Number of Participants With SEA-BCMA, ATA: Part B
A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.
Anytime during study (maximum up to 34 months)
Number of Participants With SEA-BCMA, ATA: Part C
A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.
Anytime during study (maximum up to 37 months)
Number of Participants With SEA-BCMA, ATA: Part D
A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.
Anytime during study (maximum up to 20 months)
Objective Response Rate (ORR) as Per the International Myeloma Working Group (IMWG) Uniform Response Criteria: Part A
ORR: Percentage of participants with an objective response (OR) per investigator. Participant was determined to have an OR if, based on 2016 IMWG uniform response criteria, & achieved stringent complete response (sCR), Complete response (CR), very good partial response(VGPR) & partial response(PR): free light chain(FLC) ratio & absence of clonal cells in bone marrow by immunohistochemistry(IC)/ immunofluorescence(IF). CR: negative immunofixation of serum & urine, disappearance of any soft tissue plasmacytomas(STP), 5% plasma cells in bone marrow. VGPR: serum & urine M-protein (UMP) detectable by immunofixation but not on electrophoresis/ >= 90% reduction in serum M-protein (SMP) level+UMP level <100 mg/24 hr, PR: >=50% reduction of SMP & reduction in 24-hr urinary M-protein by >=90%/to <200 mg/24 hr. If SMP & UMP are unmeasurable, a ≥50% decrease in the difference between involved & uninvolved FLC levels were required in place of the M-protein criteria.
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 45 months)
ORR as Per the IMWG Uniform Response Criteria: Part B
The ORR was defined as the percentage of participants with an OR per investigator. A participant was determined to have an OR if, based on the 2016 IMWG uniform response criteria, and achieved a sCR, CR, VGPR, or a PR. sCR: FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: negative immunofixation of serum & urine, disappearance of any STP, 5% plasma cells in bone marrow. VGPR: serum and UMP detectable by immunofixation but not on electrophoresis or >= 90% reduction in SMP level+UMP level <100 mg/24 hour, PR: >=50% reduction of SMP & reduction in 24-hour urinary M-protein by >=90%/to <200 mg/24 hour. If SMP & UMP are unmeasurable, a ≥50% decrease in the difference between involved & uninvolved FLC levels were required in place of the M-protein criteria. In addition to above criteria, if present at baseline, >=50% reduction in the size of STP were also required.
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34 months)
ORR as Per the IMWG Uniform Response Criteria: Part C
The ORR was defined as the percentage of participants with an OR per investigator. A participant was determined to have an OR if, based on the 2016 IMWG uniform response criteria, and achieved a sCR, CR, VGPR, or a PR. sCR: FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: negative immunofixation of serum & urine, disappearance of any STP, 5% plasma cells in bone marrow. VGPR: serum and UMP detectable by immunofixation but not on electrophoresis or >= 90% reduction in SMP level+UMP level <100 mg/24 hour, PR: >=50% reduction of SMP & reduction in 24-hour urinary M-protein by >=90%/to <200 mg/24 hour. If SMP & UMP are unmeasurable, a ≥50% decrease in the difference between involved & uninvolved FLC levels were required in place of the M-protein criteria. In addition to above criteria, if present at baseline, >=50% reduction in the size of STP were also required.
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 37 months)
ORR as Per the IMWG Uniform Response Criteria: Part D
The ORR was defined as the percentage of participants with an OR per investigator. A participant was determined to have an OR if, based on the 2016 IMWG uniform response criteria, and achieved a sCR, CR, VGPR, or a PR. sCR: FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: negative immunofixation of serum & urine, disappearance of any STP, 5% plasma cells in bone marrow. VGPR: serum and UMP detectable by immunofixation but not on electrophoresis/ >= 90% reduction in SMP level+UMP level <100 mg/24 hour, PR: >=50% reduction of SMP & reduction in 24-hour urinary M-protein by >=90%/to <200 mg/24 hour. If SMP & UMP are unmeasurable, a ≥50% decrease in the difference between involved & uninvolved FLC levels were required in place of the M-protein criteria. In addition to above criteria, if present at baseline, >=50% reduction in the size of STP were also required.
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 20 months)
Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A
BOR consisted of MRD-negative CR,sCR,CR,VGPR,PR,MR,SD & PD per 2016 IMWG. MRD: evaluated using adaptive next generation sequencing(NGS) for MRD assay & carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR & normal FLC ratio & absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum & urine disappearance of any STP, & <5% plasma cells in bone marrow. VGPR: SMP & UMP detectable by IF but not on electrophoresis/ >= 90% reduction(R) in SMP level+UMP level <100 mg/24 hr, PR: >=50% R of SMP & R in 24-hr UMP by >=90%/by <200 mg/24 hr. If SMP & UMP are unmeasurable, >=50% decrease in difference between involved & uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP & R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) &/clinical progression/investigator.
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 45 months)
Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part B
BOR consisted of MRD-negative CR, sCR, CR, VGPR, PR, MR, SD & PD per 2016 IMWG. MRD: evaluated using adaptive NGS for MRD assay & carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR & normal FLC ratio & absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum & urine disappearance of any STP, & <5% plasma cells in bone marrow. VGPR: SMP & UMP detectable by IF but not on electrophoresis/ >= 90% reduction(R) in SMP level+UMP level <100 mg/24 hr, PR: >=50% R of SMP & R in 24-hr UMP by >=90%/by <200 mg/24 hr. If SMP & UMP are unmeasurable, >=50% decrease in difference between involved & uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP & R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) &/clinical progression/investigator.
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34 months)
Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C
BOR consisted of MRD-negative CR, sCR, CR, VGPR, PR, MR, SD & PD per 2016 IMWG. MRD: evaluated using NGS for MRD assay & carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR & normal FLC ratio & absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum & urine disappearance of any STP, & <5% plasma cells in bone marrow. VGPR: SMP & UMP detectable by IF but not on electrophoresis/ >= 90% reduction(R) in SMP level+UMP level <100 mg/24 hr, PR: >=50% R of SMP & R in 24-hr UMP by >=90%/by <200 mg/24 hr. If SMP & UMP are unmeasurable, >=50% decrease in difference between involved & uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP & R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) &/clinical progression/investigator.
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 37 months)
Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part D
BOR consisted of MRD-negative CR,sCR,CR,VGPR,PR,MR,SD & PD per 2016 IMWG. MRD: evaluated using adaptive NGS for MRD assay & carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR & normal FLC ratio & absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum & urine disappearance of any STP, & <5% plasma cells in bone marrow. VGPR: SMP & UMP detectable by IF but not on electrophoresis/ >= 90% reduction(R) in SMP level+UMP level <100 mg/24 hr, PR: >=50% R of SMP & R in 24-hr UMP by >=90%/by <200 mg/24 hr. If SMP & UMP are unmeasurable, >=50% decrease in difference between involved & uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP & R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) &/clinical progression/investigator.
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 20 months)
Duration of Objective Response (DOR) as Per the IMWG Uniform Response Criteria: Part A
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) &/clinical progression/ investigator. sCR: CR, normal FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum&urine, disappearance of any STP, &<5% plasma cells in bone marrow. VGPR: Serum & UMP detectable by immunofixation but not on electrophoresis/ >= 90% reduction(R) in SMP level+UMP level <100 mg/24 hour, PR: >=50%R of SMP & R in 24-hour UMP by >=90% or to <200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD & were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 45 months)
DOR as Per the IMWG Uniform Response Criteria: Part B
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) &/clinical progression/ investigator. sCR: CR, normal FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum&urine, disappearance of any STP, &<5% plasma cells in bone marrow. VGPR: Serum & UMP detectable by immunofixation but not on electrophoresis/ >= 90% reduction(R) in SMP level+UMP level <100 mg/24 hour, PR: >=50%R of SMP & R in 24-hour UMP by >=90% or to <200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD & were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 34 months)
DOR as Per the IMWG Uniform Response Criteria: Part C
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) &/clinical progression/ investigator. sCR: CR, normal FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum&urine, disappearance of any STP, &<5% plasma cells in bone marrow. VGPR: Serum & UMP detectable by immunofixation but not on electrophoresis/ >= 90% reduction(R) in SMP level+UMP level <100 mg/24 hour, PR: >=50%R of SMP & R in 24-hour UMP by >=90% or to <200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD & were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 37 months)
DOR as Per the IMWG Uniform Response Criteria: Part D
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) &/clinical progression/ investigator. sCR: CR, normal FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum&urine, disappearance of any STP, &<5% plasma cells in bone marrow. VGPR: Serum & UMP detectable by immunofixation but not on electrophoresis/ >= 90% reduction(R) in SMP level+UMP level <100 mg/24 hour, PR: >=50%R of SMP & R in 24-hour UMP by >=90% or to <200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD & were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 20 months)
Progression Free Survival (PFS): Part A
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 45 months)
PFS: Part B
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 34 months)
PFS: Part C
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 37 months)
PFS: Part D
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 20 months)
Overall Survival (OS): Part A
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
From date of start of study treatment until date of death or censoring date (maximum up to 45 months)
OS: Part B
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
From date of start of study treatment until date of death or censoring date (maximum up to 34 months)
OS: Part C
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
From date of start of study treatment until date of death or censoring date (maximum up to 37 months)
OS: Part D
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
From date of start of study treatment until date of death or censoring date (maximum up to 20 months)
Aurora
Colorado
80012
United States
University of Miami
Miami
Florida
33136
United States
Holden Comprehensive Cancer Center / University of Iowa
Iowa City
Iowa
52242
United States
University of Kansas Cancer Center
Westwood
Kansas
66205
United States
Washington University in St Louis
St Louis
Missouri
63110
United States
Weill Cornell Medicine
New York
New York
10065
United States
James P. Wilmot Cancer Center / University of Rochester Medical Center
Rochester
New York
14642
United States
Willamette Valley Cancer Institute and Research Center
Eugene
Oregon
97401
United States
Texas Oncology - Austin Midtown
Austin
Texas
78705
United States
Texas Oncology - Northeast Texas
Tyler
Texas
75702
United States
Virginia Cancer Specialists, PC
Fairfax
Virginia
22031
United States
Fred Hutchinson Cancer Research Center
Seattle
Washington
98109
United States
Part A: SEA-BCMA 200mg
Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
FG002
Part A: SEA-BCMA 400mg
Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
FG003
Part A: SEA-BCMA 800mg
Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
FG004
Part A: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
FG005
Part B: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as an IV infusion once every 1 week (q1wk) as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
FG006
Part C: SEA-BCMA 1600mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
FG007
Part C: SEA-BCMA 800mg and Dexamethasone
Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
FG008
Part C: SEA-BCMA 1600 mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
FG009
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0037 subjects
FG00422 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0037 subjects
FG00422 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Death
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0034 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study terminated by sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Part B
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00520 subjectsParticipants who were enrolled in Part-B of the study.
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part C
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00612 subjectsParticipants who were enrolled in Part-C of the study.
FG0076 subjectsParticipants who were enrolled in Part-C of the study.
FG0085 subjectsParticipants who were enrolled in Part-C of the study.
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part D
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0095 subjectsParticipants who were enrolled in Part-D of the study.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: SEA-BCMA 100mg
Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
BG001
Part A: SEA-BCMA 200mg
Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
BG002
Part A: SEA-BCMA 400mg
Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
BG003
Part A: SEA-BCMA 800mg
Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
BG004
Part A: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
BG005
Part B: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
BG006
Part C: SEA-BCMA 1600mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
BG007
Part C: SEA-BCMA 800mg and Dexamethasone
Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
BG008
Part C: SEA-BCMA 1600 mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
BG009
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0002
BG0012
BG0022
BG0037
BG00422
BG00520
BG00612
BG0076
BG0085
BG0095
BG01083
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00068.5± 2.1
BG00170.0± 7.1
BG00272.5± 9.2
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A
An adverse event (AE) was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of investigational product (IP). TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity & may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 44 months (maximum follow up of 45 months)
ID
Title
Description
OG000
Part A: SEA-BCMA 100mg
Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG001
Part A: SEA-BCMA 200mg
Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG002
Part A: SEA-BCMA 400mg
Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG003
Part A: SEA-BCMA 800mg
Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG004
Part A: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG003
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0002
OG0012
OG0022
OG003
Primary
Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part B
An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity & may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 33 months (maximum follow up of 34 months)
ID
Title
Description
OG000
Part B: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Primary
Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part C
An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity & may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 36 months (maximum follow up of 37 months)
ID
Title
Description
OG000
Part C: SEA-BCMA 1600mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG001
Primary
Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part D
An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity & may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 19 months (maximum follow up of 20 months)
ID
Title
Description
OG000
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Primary
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A
The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 44 months (maximum follow up of 45 months)
ID
Title
Description
OG000
Part A: SEA-BCMA 100mg
Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG001
Part A: SEA-BCMA 200mg
Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Primary
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part B
The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 33 months (maximum follow up of 34 months)
ID
Title
Description
OG000
Part B: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Primary
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part C
The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 36 months (maximum follow up of 37 months)
ID
Title
Description
OG000
Part C: SEA-BCMA 1600mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG001
Part C: SEA-BCMA 800mg and Dexamethasone
Primary
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part D
The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Participants with any serum chemistry parameter meeting CTCAE grade 1 to 4 were reported.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 19 months (maximum follow up of 20 months)
ID
Title
Description
OG000
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Primary
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A
The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 44 months (maximum follow up of 45 months)
ID
Title
Description
OG000
Part A: SEA-BCMA 100mg
Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG001
Part A: SEA-BCMA 200mg
Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Primary
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part B
The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 33 months (maximum follow up of 34 months)
ID
Title
Description
OG000
Part B: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
Primary
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part C
The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 36 months (maximum follow up of 37 months)
ID
Title
Description
OG000
Part C: SEA-BCMA 1600mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG001
Part C: SEA-BCMA 800mg and Dexamethasone
Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Primary
Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part D
The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 19 months (maximum follow up of 20 months)
ID
Title
Description
OG000
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
Primary
Number of Participants With Dose Limiting Toxicities (DLTs): Part A
The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE >=Grade 3, unless deemed by the safety monitoring committee (SMC) to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death.
The DLT-evaluable (DE) analysis set included treated participants who either experienced a DLT, or were followed up for the full DLT evaluation period and received at least 75% of the intended total Cycle 1 SEA-BCMA dose, and did not receive prohibited treatment.
Posted
Count of Participants
Participants
Cycle 1 (28 days)
ID
Title
Description
OG000
Part A: SEA-BCMA 100mg
Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG001
Part A: SEA-BCMA 200mg
Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Primary
Number of Participants With DLTs: Part B
The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE >=Grade 3, unless deemed by the SMC to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death.
The DE analysis set included treated participants who either experienced a DLT, or were followed up for the full DLT evaluation period and received at least 75% of the intended total Cycle 1 SEA-BCMA dose, and did not receive prohibited treatment.
Posted
Count of Participants
Participants
Cycle 1 (28 days)
ID
Title
Description
OG000
Part B: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
Primary
Number of Participants With DLTs: Part C
The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE >=Grade 3, unless deemed by the SMC to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death.
The DE analysis set included treated participants who either experienced a DLT, or were followed up for the full DLT evaluation period and received at least 75% of the intended total Cycle 1 SEA-BCMA dose, and did not receive prohibited treatment.
Posted
Count of Participants
Participants
Cycle 1 (28 days)
ID
Title
Description
OG000
Part C: SEA-BCMA 1600mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG001
Part C: SEA-BCMA 800mg and Dexamethasone
Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Primary
Number of Participants With DLTs: Part D
The DLT-evaluation period was the first cycle of treatment. DLTs were graded according to the NCI-CTCAE, v 4.03, and were defined as any of the following events during the DLT-evaluation period: a ) A delay of SEA-BCMA treatment by more than 7 days due to toxicity, b) Any AE >=Grade 3, unless deemed by the SMC to be clearly unrelated to SEA-BCMA except for the AEs as pre specified in protocol to be considered a DLT and c) Any treatment related death.
The DE analysis set included treated participants who either experienced a DLT, or were followed up for the full DLT evaluation period and received at least 75% of the intended total Cycle 1 SEA-BCMA dose, and did not receive prohibited treatment.
Posted
Count of Participants
Participants
Cycle 1 (28 days)
ID
Title
Description
OG000
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
Secondary
Area Under the Serum Concentration-Time Curve From Time 0 to Day 14 (AUC0-14) of SEA-BCMA: Part A
Area under the observed concentration-time curve from the time of dosing to Day 14 calculated by log-linear trapezoidal approximation.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Day*micrograms per milliliter (ug/mL)
Cycle 1 and 2: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1
ID
Title
Description
OG000
Part A: SEA-BCMA 100mg
Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG001
Part A: SEA-BCMA 200mg
Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG002
Part A: SEA-BCMA 400mg
Secondary
Area Under the Serum Concentration-Time Curve From Time 0 to Day 7 (AUC0-7) of SEA-BCMA: Part A
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Geometric Mean
Geometric Coefficient of Variation
Day*ug/mL
Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1
ID
Title
Description
OG000
Part A: SEA-BCMA 100mg
Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG001
Part A: SEA-BCMA 200mg
Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG002
Part A: SEA-BCMA 400mg
Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Secondary
AUC0-7 of SEA-BCMA: Part B
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Day*ug/mL
Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1
ID
Title
Description
OG000
Part B: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG000
Secondary
AUC0-7 of SEA-BCMA: Part C
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Day*ug/mL
Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1
ID
Title
Description
OG000
Part C: SEA-BCMA 1600mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG001
Part C: SEA-BCMA 800mg and Dexamethasone
Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Secondary
AUC0-7 of SEA-BCMA: Part D
Area under the observed concentration-time curve from the time of dosing to Day 7 calculated by log-linear trapezoidal approximation.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Day*ug/mL
Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, and 168 hours post end of infusion on Day 1
ID
Title
Description
OG000
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG000
Secondary
Maximum Observed Serum Concentration (Cmax) of SEA-BCMA: Part A
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Micrograms per milliliter (ug/mL)
Cycle 1 and 2: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 and 15
ID
Title
Description
OG000
Part A: SEA-BCMA 100mg
Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG001
Part A: SEA-BCMA 200mg
Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG002
Part A: SEA-BCMA 400mg
Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Secondary
Cmax of SEA-BCMA: Part B
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 and 15
ID
Title
Description
OG000
Part B: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG000
Secondary
Cmax of SEA-BCMA: Part C
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
Cycle 1: Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 and 15
ID
Title
Description
OG000
Part C: SEA-BCMA 1600mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG001
Part C: SEA-BCMA 800mg and Dexamethasone
Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG002
Part C: SEA-BCMA 1600 mg and Dexamethasone
Secondary
Cmax of SEA-BCMA: Part D
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
Cycle 1:Pre dose, 1 and 2 hour intradose, end of drug administration, 2, 6 , 24, 72, 168 and 336 hours post end of infusion on Day 1 and 15
ID
Title
Description
OG000
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG000
Secondary
Number of Participants With SEA-BCMA Antitherapeutic Antibodies (ATA): Part A
A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Anytime during study (maximum up to 45 months)
ID
Title
Description
OG000
Part A: SEA-BCMA 100mg
Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG001
Part A: SEA-BCMA 200mg
Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG002
Part A: SEA-BCMA 400mg
Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Secondary
Number of Participants With SEA-BCMA, ATA: Part B
A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Anytime during study (maximum up to 34 months)
ID
Title
Description
OG000
Part B: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG000
Secondary
Number of Participants With SEA-BCMA, ATA: Part C
A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Anytime during study (maximum up to 37 months)
ID
Title
Description
OG000
Part C: SEA-BCMA 1600mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG001
Part C: SEA-BCMA 800mg and Dexamethasone
Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG002
Secondary
Number of Participants With SEA-BCMA, ATA: Part D
A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Anytime during study (maximum up to 20 months)
ID
Title
Description
OG000
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG000
Secondary
Objective Response Rate (ORR) as Per the International Myeloma Working Group (IMWG) Uniform Response Criteria: Part A
ORR: Percentage of participants with an objective response (OR) per investigator. Participant was determined to have an OR if, based on 2016 IMWG uniform response criteria, & achieved stringent complete response (sCR), Complete response (CR), very good partial response(VGPR) & partial response(PR): free light chain(FLC) ratio & absence of clonal cells in bone marrow by immunohistochemistry(IC)/ immunofluorescence(IF). CR: negative immunofixation of serum & urine, disappearance of any soft tissue plasmacytomas(STP), 5% plasma cells in bone marrow. VGPR: serum & urine M-protein (UMP) detectable by immunofixation but not on electrophoresis/ >= 90% reduction in serum M-protein (SMP) level+UMP level <100 mg/24 hr, PR: >=50% reduction of SMP & reduction in 24-hr urinary M-protein by >=90%/to <200 mg/24 hr. If SMP & UMP are unmeasurable, a ≥50% decrease in the difference between involved & uninvolved FLC levels were required in place of the M-protein criteria.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Number
95% Confidence Interval
Percentage of participants
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 45 months)
ID
Title
Description
OG000
Part A: SEA-BCMA 100mg
Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Secondary
ORR as Per the IMWG Uniform Response Criteria: Part B
The ORR was defined as the percentage of participants with an OR per investigator. A participant was determined to have an OR if, based on the 2016 IMWG uniform response criteria, and achieved a sCR, CR, VGPR, or a PR. sCR: FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: negative immunofixation of serum & urine, disappearance of any STP, 5% plasma cells in bone marrow. VGPR: serum and UMP detectable by immunofixation but not on electrophoresis or >= 90% reduction in SMP level+UMP level <100 mg/24 hour, PR: >=50% reduction of SMP & reduction in 24-hour urinary M-protein by >=90%/to <200 mg/24 hour. If SMP & UMP are unmeasurable, a ≥50% decrease in the difference between involved & uninvolved FLC levels were required in place of the M-protein criteria. In addition to above criteria, if present at baseline, >=50% reduction in the size of STP were also required.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Number
95% Confidence Interval
Percentage of participants
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34 months)
ID
Title
Description
OG000
Part B: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Secondary
ORR as Per the IMWG Uniform Response Criteria: Part C
The ORR was defined as the percentage of participants with an OR per investigator. A participant was determined to have an OR if, based on the 2016 IMWG uniform response criteria, and achieved a sCR, CR, VGPR, or a PR. sCR: FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: negative immunofixation of serum & urine, disappearance of any STP, 5% plasma cells in bone marrow. VGPR: serum and UMP detectable by immunofixation but not on electrophoresis or >= 90% reduction in SMP level+UMP level <100 mg/24 hour, PR: >=50% reduction of SMP & reduction in 24-hour urinary M-protein by >=90%/to <200 mg/24 hour. If SMP & UMP are unmeasurable, a ≥50% decrease in the difference between involved & uninvolved FLC levels were required in place of the M-protein criteria. In addition to above criteria, if present at baseline, >=50% reduction in the size of STP were also required.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Number
95% Confidence Interval
Percentage of participants
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 37 months)
ID
Title
Description
OG000
Part C: SEA-BCMA 1600mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Secondary
ORR as Per the IMWG Uniform Response Criteria: Part D
The ORR was defined as the percentage of participants with an OR per investigator. A participant was determined to have an OR if, based on the 2016 IMWG uniform response criteria, and achieved a sCR, CR, VGPR, or a PR. sCR: FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: negative immunofixation of serum & urine, disappearance of any STP, 5% plasma cells in bone marrow. VGPR: serum and UMP detectable by immunofixation but not on electrophoresis/ >= 90% reduction in SMP level+UMP level <100 mg/24 hour, PR: >=50% reduction of SMP & reduction in 24-hour urinary M-protein by >=90%/to <200 mg/24 hour. If SMP & UMP are unmeasurable, a ≥50% decrease in the difference between involved & uninvolved FLC levels were required in place of the M-protein criteria. In addition to above criteria, if present at baseline, >=50% reduction in the size of STP were also required.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Number
95% Confidence Interval
Percentage of participants
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 20 months)
ID
Title
Description
OG000
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Secondary
Percentage of Participants With Best Overall Response (BOR) as Per the IMWG Uniform Response Criteria: Part A
BOR consisted of MRD-negative CR,sCR,CR,VGPR,PR,MR,SD & PD per 2016 IMWG. MRD: evaluated using adaptive next generation sequencing(NGS) for MRD assay & carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR & normal FLC ratio & absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum & urine disappearance of any STP, & <5% plasma cells in bone marrow. VGPR: SMP & UMP detectable by IF but not on electrophoresis/ >= 90% reduction(R) in SMP level+UMP level <100 mg/24 hr, PR: >=50% R of SMP & R in 24-hr UMP by >=90%/by <200 mg/24 hr. If SMP & UMP are unmeasurable, >=50% decrease in difference between involved & uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP & R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) &/clinical progression/investigator.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Number
Percentage of participants
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 45 months)
ID
Title
Description
OG000
Part A: SEA-BCMA 100mg
Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Secondary
Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part B
BOR consisted of MRD-negative CR, sCR, CR, VGPR, PR, MR, SD & PD per 2016 IMWG. MRD: evaluated using adaptive NGS for MRD assay & carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR & normal FLC ratio & absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum & urine disappearance of any STP, & <5% plasma cells in bone marrow. VGPR: SMP & UMP detectable by IF but not on electrophoresis/ >= 90% reduction(R) in SMP level+UMP level <100 mg/24 hr, PR: >=50% R of SMP & R in 24-hr UMP by >=90%/by <200 mg/24 hr. If SMP & UMP are unmeasurable, >=50% decrease in difference between involved & uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP & R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) &/clinical progression/investigator.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Number
Percentage of participants
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34 months)
ID
Title
Description
OG000
Part B: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Secondary
Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part C
BOR consisted of MRD-negative CR, sCR, CR, VGPR, PR, MR, SD & PD per 2016 IMWG. MRD: evaluated using NGS for MRD assay & carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR & normal FLC ratio & absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum & urine disappearance of any STP, & <5% plasma cells in bone marrow. VGPR: SMP & UMP detectable by IF but not on electrophoresis/ >= 90% reduction(R) in SMP level+UMP level <100 mg/24 hr, PR: >=50% R of SMP & R in 24-hr UMP by >=90%/by <200 mg/24 hr. If SMP & UMP are unmeasurable, >=50% decrease in difference between involved & uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP & R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) &/clinical progression/investigator.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Number
Percentage of participants
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 37 months)
ID
Title
Description
OG000
Part C: SEA-BCMA 1600mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Secondary
Percentage of Participants With BOR as Per the IMWG Uniform Response Criteria: Part D
BOR consisted of MRD-negative CR,sCR,CR,VGPR,PR,MR,SD & PD per 2016 IMWG. MRD: evaluated using adaptive NGS for MRD assay & carried out on relevant specimen to understand activity of SEA-BCMA. sCR: CR & normal FLC ratio & absence of clonal cells in bone marrow by IC/ IF. CR: Negative immunofixation of serum & urine disappearance of any STP, & <5% plasma cells in bone marrow. VGPR: SMP & UMP detectable by IF but not on electrophoresis/ >= 90% reduction(R) in SMP level+UMP level <100 mg/24 hr, PR: >=50% R of SMP & R in 24-hr UMP by >=90%/by <200 mg/24 hr. If SMP & UMP are unmeasurable, >=50% decrease in difference between involved & uninvolved FLC levels were required in place of M-protein criteria. SD: Not meeting criteria for CR, VGPR, PR, MR, or progression. MR: 25-49% R of SMP & R in 24-hr UMP by 50-89%, which still exceeds 200mg/24 hr. DP: objective evidence of tumor progression(based on serum/urine/BM assessments) &/clinical progression/investigator.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Number
Percentage of participants
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 20 months)
ID
Title
Description
OG000
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Secondary
Duration of Objective Response (DOR) as Per the IMWG Uniform Response Criteria: Part A
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) &/clinical progression/ investigator. sCR: CR, normal FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum&urine, disappearance of any STP, &<5% plasma cells in bone marrow. VGPR: Serum & UMP detectable by immunofixation but not on electrophoresis/ >= 90% reduction(R) in SMP level+UMP level <100 mg/24 hour, PR: >=50%R of SMP & R in 24-hour UMP by >=90% or to <200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD & were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Median
Full Range
Months
From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 45 months)
ID
Title
Description
OG000
Part A: SEA-BCMA 100mg
Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Secondary
DOR as Per the IMWG Uniform Response Criteria: Part B
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) &/clinical progression/ investigator. sCR: CR, normal FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum&urine, disappearance of any STP, &<5% plasma cells in bone marrow. VGPR: Serum & UMP detectable by immunofixation but not on electrophoresis/ >= 90% reduction(R) in SMP level+UMP level <100 mg/24 hour, PR: >=50%R of SMP & R in 24-hour UMP by >=90% or to <200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD & were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Median
Full Range
Months
From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 34 months)
ID
Title
Description
OG000
Part B: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Secondary
DOR as Per the IMWG Uniform Response Criteria: Part C
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) &/clinical progression/ investigator. sCR: CR, normal FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum&urine, disappearance of any STP, &<5% plasma cells in bone marrow. VGPR: Serum & UMP detectable by immunofixation but not on electrophoresis/ >= 90% reduction(R) in SMP level+UMP level <100 mg/24 hour, PR: >=50%R of SMP & R in 24-hour UMP by >=90% or to <200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD & were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Median
Full Range
Months
From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 37 months)
ID
Title
Description
OG000
Part C: SEA-BCMA 1600mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Secondary
DOR as Per the IMWG Uniform Response Criteria: Part D
DOR: Time from first documentation of OR(sCR,CR,VGPR/PR) to first documentation of PD/death due to any cause, whichever came first. PD: Objective evidence of tumor progression(TP) (based on serum, urine/BM assessments) &/clinical progression/ investigator. sCR: CR, normal FLC ratio & absence of clonal cells in bone marrow by IC/IF. CR: Negative immunofixation of serum&urine, disappearance of any STP, &<5% plasma cells in bone marrow. VGPR: Serum & UMP detectable by immunofixation but not on electrophoresis/ >= 90% reduction(R) in SMP level+UMP level <100 mg/24 hour, PR: >=50%R of SMP & R in 24-hour UMP by >=90% or to <200 mg/24 hour. DOR: censored on date of last disease assessment documenting absence of PD for participants who do not have PD & were still on study at the time of an analysis/removed from study prior to documentation of TP. Participants started new antitumor treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Median
Full Range
Months
From the first dose of study treatment until the first documented OR (sCR or CR or PR or VGPR) on or before the first documented PD or death or censoring date, whichever occurred first (maximum up to 20 months)
ID
Title
Description
OG000
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Secondary
Progression Free Survival (PFS): Part A
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Median
Full Range
Months
From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 45 months)
ID
Title
Description
OG000
Part A: SEA-BCMA 100mg
Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG001
Part A: SEA-BCMA 200mg
Secondary
PFS: Part B
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Median
Full Range
Months
From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 34 months)
ID
Title
Description
OG000
Part B: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Secondary
PFS: Part C
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Median
Full Range
Months
From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 37 months)
ID
Title
Description
OG000
Part C: SEA-BCMA 1600mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG001
Part C: SEA-BCMA 800mg and Dexamethasone
Secondary
PFS: Part D
PFS: Time from the start of any study treatment to first documentation of DP or to death due to any cause, whichever comes first. DP included objective evidence of tumor progression (based on serum, urine or BM assessments) and/or clinical progression per investigator. PFS was censored on the date of the last disease assessment documenting absence of PD for participants who do not have disease progression and are still on study at the time of an analysis, or discontinuation of study prior to documentation of tumor progression. Participants who have started a new antitumor treatment prior to documentation of PD were censored at the last disease assessment prior to start of new treatment. Participants lacking an evaluation of tumor response after their first dose had their event time censored as 1 day.
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Median
Full Range
Months
From the date of first dose until the first documentation of PD or death or censoring date, whichever occurred first (maximum up to 20 months)
ID
Title
Description
OG000
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Secondary
Overall Survival (OS): Part A
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Median
Full Range
Months
From date of start of study treatment until date of death or censoring date (maximum up to 45 months)
ID
Title
Description
OG000
Part A: SEA-BCMA 100mg
Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG001
Part A: SEA-BCMA 200mg
Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Secondary
OS: Part B
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Median
Full Range
Months
From date of start of study treatment until date of death or censoring date (maximum up to 34 months)
ID
Title
Description
OG000
Part B: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
Secondary
OS: Part C
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Median
Full Range
Months
From date of start of study treatment until date of death or censoring date (maximum up to 37 months)
ID
Title
Description
OG000
Part C: SEA-BCMA 1600mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG001
Part C: SEA-BCMA 800mg and Dexamethasone
Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Secondary
OS: Part D
OS was defined as the time from the start of any study treatment to the date of death due to any cause. OS was calculated as date of death minus date of first dose of any study treatment plus 1. OS for participants who were alive at their date of last contact, including those lost to follow-up, were censored at the date of last contact. If the last recorded date where a participant was known to be alive is the date of first dose of any study treatment, survival time was censored on the date of first dose of any study treatment (i.e., OS duration of 1 day).
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
Posted
Median
Full Range
Months
From date of start of study treatment until date of death or censoring date (maximum up to 20 months)
ID
Title
Description
OG000
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
Time Frame
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment for Part A: up to 44 months (maximum follow up of 45 months); Part B: up to 33 months (maximum follow up of 34 months); Part C: up to 36 months (maximum follow up of 37 months) and Part D: up to 19 months (maximum follow up of 20 months)
Description
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A: SEA-BCMA 100mg
Participants received SEA-BCMA 100 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
1
2
1
2
2
2
EG001
Part A: SEA-BCMA 200mg
Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
1
2
1
2
2
2
EG002
Part A: SEA-BCMA 400mg
Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
2
2
2
2
2
2
EG003
Part A: SEA-BCMA 800mg
Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
4
7
3
7
6
7
EG004
Part A: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
11
22
8
22
18
22
EG005
Part B: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as an IV infusion q1wk as induction dose for the first two cycles, followed by q2wk as maintenance dose in subsequent cycles, of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
2
20
5
20
17
20
EG006
Part C: SEA-BCMA 1600mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
6
12
5
12
10
12
EG007
Part C: SEA-BCMA 800mg and Dexamethasone
Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
1
6
3
6
5
6
EG008
Part C: SEA-BCMA 1600 mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
2
5
2
5
5
5
EG009
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 and pomalidomide 4 mg orally, daily from Day 1 to 21 of each of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
1
5
3
5
5
5
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Cystic fibrosis
Congenital, familial and genetic disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Fatigue
General disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pyrexia
General disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Cholelithiasis obstructive
Hepatobiliary disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
COVID-19
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Campylobacter colitis
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Infectious pleural effusion
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Influenza
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Sepsis
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Septic shock
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Streptococcal bacteraemia
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Procedural complication
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Procedural nausea
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Procedural vomiting
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Enthesopathy
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Parkinson's disease
Nervous system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hypotension
Vascular disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG0032 events2 affected7 at risk
EG0044 events3 affected22 at risk
EG0050 events0 affected20 at risk
EG0066 events5 affected12 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected5 at risk
Anaemia macrocytic
Blood and lymphatic system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Cardiac disorder
Cardiac disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Palpitations
Cardiac disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Vestibular disorder
Ear and labyrinth disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Cataract
Eye disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Eye haemorrhage
Eye disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Eyelid haematoma
Eye disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Photophobia
Eye disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Vision blurred
Eye disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Asthenia
General disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Chills
General disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Facial pain
General disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Fatigue
General disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Feeling cold
General disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Influenza like illness
General disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Malaise
General disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Oedema peripheral
General disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pyrexia
General disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Hypogammaglobulinaemia
Immune system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
COVID-19
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Diverticulitis intestinal perforated
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Fungal infection
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
H1N1 influenza
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Influenza
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Laryngitis
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Mastoiditis
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Sepsis
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Skin candida
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Skin infection
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Tooth infection
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0022 events2 affected2 at risk
EG003
Viral diarrhoea
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0012 events1 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Tissue injury
Injury, poisoning and procedural complications
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Amylase increased
Investigations
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Blood lactic acid increased
Investigations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Immunoglobulins decreased
Investigations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Lipase increased
Investigations
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Platelet count decreased
Investigations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Serum ferritin decreased
Investigations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Weight increased
Investigations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
White blood cell count decreased
Investigations
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA v26.1
Systematic Assessment
EG0001 events1 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected2 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Soft tissue swelling
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Torticollis
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v26.1
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG003
Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG002
Part C: SEA-BCMA 1600 mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG00012
OG0016
OG0025
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00011
OG0016
OG0025
TESAEs
Title
Measurements
OG0005
OG0013
OG0022
Treatment Related TEAEs
Title
Measurements
OG0004
OG0010
OG0023
TEAEs (>= Grade 3)
Title
Measurements
OG0008
OG0015
OG0023
Units
Counts
Participants
OG0005
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0005
TESAEs
Title
Measurements
OG0003
Treatment Related TEAEs
Title
Measurements
OG0003
TEAEs (>= Grade 3)
Title
Measurements
OG0003
OG002
Part A: SEA-BCMA 400mg
Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG003
Part A: SEA-BCMA 800mg
Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG004
Part A: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0037
OG00422
Title
Denominators
Categories
Grade 1
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0044
Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3
Title
Measurements
OG0000
OG0011
OG0022
OG003
Grade 4
Title
Measurements
OG0002
OG0010
OG0020
OG003
Units
Counts
Participants
OG00020
Title
Denominators
Categories
Grade 1
Title
Measurements
OG0005
Grade 2
Title
Measurements
OG0008
Grade 3
Title
Measurements
OG0006
Grade 4
Title
Measurements
OG0001
Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG002
Part C: SEA-BCMA 1600 mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG00012
OG0016
OG0025
Title
Denominators
Categories
Grade 1
Title
Measurements
OG0000
OG0011
OG0021
Grade 2
Title
Measurements
OG0005
OG0011
OG0022
Grade 3
Title
Measurements
OG0005
OG0013
OG0022
Grade 4
Title
Measurements
OG0002
OG0011
OG0020
Units
Counts
Participants
OG0005
Title
Denominators
Categories
Grade 1
Title
Measurements
OG0001
Grade 2
Title
Measurements
OG0001
Grade 3
Title
Measurements
OG0003
Grade 4
Title
Measurements
OG0000
OG002
Part A: SEA-BCMA 400mg
Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG003
Part A: SEA-BCMA 800mg
Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG004
Part A: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0037
OG00422
Title
Denominators
Categories
Grade 1
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0040
Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 3
Title
Measurements
OG0001
OG0011
OG0021
OG003
Grade 4
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG00020
Title
Denominators
Categories
Grade 1
Title
Measurements
OG0006
Grade 2
Title
Measurements
OG0006
Grade 3
Title
Measurements
OG0007
Grade 4
Title
Measurements
OG0001
OG002
Part C: SEA-BCMA 1600 mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG00012
OG0016
OG0025
Title
Denominators
Categories
Grade 1
Title
Measurements
OG0001
OG0011
OG0021
Grade 2
Title
Measurements
OG0003
OG0013
OG0020
Grade 3
Title
Measurements
OG0004
OG0012
OG0023
Grade 4
Title
Measurements
OG0004
OG0010
OG0021
OG0005
Title
Denominators
Categories
Grade 1
Title
Measurements
OG0000
Grade 2
Title
Measurements
OG0002
Grade 3
Title
Measurements
OG0001
Grade 4
Title
Measurements
OG0002
OG002
Part A: SEA-BCMA 400mg
Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG003
Part A: SEA-BCMA 800mg
Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG004
Part A: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0037
OG0047
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0006
Title
Denominators
Categories
Title
Measurements
OG0000
OG002
Part C: SEA-BCMA 1600 mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG0004
OG0015
OG0024
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0004
Title
Denominators
Categories
Title
Measurements
OG0000
Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG003
Part A: SEA-BCMA 800mg
Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG004
Part A: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0037
OG00422
Title
Denominators
Categories
Cycle 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0037
ParticipantsOG00422
Title
Measurements
OG000181.3± 20.0
OG001302.6± 14.6
OG002977.2± 37.0
OG003
Cycle 2
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0036
OG003
Part A: SEA-BCMA 800mg
Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG004
Part A: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0037
OG00422
Title
Denominators
Categories
Title
Measurements
OG000112.6± 17.6
OG001197.6± 11.1
OG002626.5± 26.3
OG003932.0± 22.1
OG0042064.5± 23.4
7
Title
Denominators
Categories
Title
Measurements
OG0002001.3± 26.4
OG002
Part C: SEA-BCMA 1600 mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG00012
OG0013
OG0022
Title
Denominators
Categories
Title
Measurements
OG0002011.8± 32.9
OG001840.3± 21.2
OG0021629.3± 20.9
1
Title
Denominators
Categories
Title
Measurements
OG0001926.2± NAGeometric CV could not be calculated as only 1 participant was available for analysis.
OG003
Part A: SEA-BCMA 800mg
Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG004
Part A: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0037
OG00421
Title
Denominators
Categories
Cycle 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0037
ParticipantsOG00421
Title
Measurements
OG00028.5± 32.3
OG00147.2± 3.9
OG002134.8± 11.6
OG003
Cycle 2
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0036
19
Title
Denominators
Categories
Title
Measurements
OG000493.3± 27.7
Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG00012
OG0015
OG0024
Title
Denominators
Categories
Title
Measurements
OG000471.5± 72.3
OG001204.2± 27.3
OG002486.4± 17.9
4
Title
Denominators
Categories
Title
Measurements
OG000415.1± 31.8
OG003
Part A: SEA-BCMA 800mg
Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG004
Part A: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG0002
OG0012
OG0021
OG0037
OG00421
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
17
Title
Denominators
Categories
Title
Measurements
OG0000
Part C: SEA-BCMA 1600 mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG00012
OG0013
OG0025
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
2
Title
Denominators
Categories
Title
Measurements
OG0000
OG001
Part A: SEA-BCMA 200mg
Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG002
Part A: SEA-BCMA 400mg
Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG003
Part A: SEA-BCMA 800mg
Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG004
Part A: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0037
OG00422
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 84.2)
OG0010(0.0 to 84.2)
OG0020(0.0 to 84.2)
OG0030(0.0 to 41.0)
OG00414(2.9 to 34.9)
Units
Counts
Participants
OG00020
Title
Denominators
Categories
Title
Measurements
OG00020(5.7 to 43.7)
OG001
Part C: SEA-BCMA 800mg and Dexamethasone
Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG002
Part C: SEA-BCMA 1600 mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG00012
OG0016
OG0025
Title
Denominators
Categories
Title
Measurements
OG00017(2.1 to 48.4)
OG00133(4.3 to 77.7)
OG00220(0.5 to 71.6)
Units
Counts
Participants
OG0005
Title
Denominators
Categories
Title
Measurements
OG00080(28.4 to 99.5)
OG001
Part A: SEA-BCMA 200mg
Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG002
Part A: SEA-BCMA 400mg
Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG003
Part A: SEA-BCMA 800mg
Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG004
Part A: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG002
Part C: SEA-BCMA 1600 mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG00012
OG0016
OG0025
Title
Denominators
Categories
MRD-negative CR
Title
Measurements
OG0000
OG0010
OG0020
sCR
Title
Measurements
OG0008
OG0010
OG0020
CR
Title
Measurements
OG0000
OG0010
OG0020
VGPR
Title
Measurements
OG0000
OG00117
OG0020
PR
Title
Measurements
OG0008
OG00117
OG00220
MR
Title
Measurements
OG0000
OG00117
OG0020
SD
Title
Measurements
OG00067
OG00133
OG00260
DP
Title
Measurements
OG00017
OG00117
OG00220
Units
Counts
Participants
OG0005
Title
Denominators
Categories
MRD-negative CR
Title
Measurements
OG0000
sCR
Title
Measurements
OG00040
CR
Title
Measurements
OG0000
VGPR
Title
Measurements
OG00020
PR
Title
Measurements
OG00020
MR
Title
Measurements
OG0000
SD
Title
Measurements
OG00020
DP
Title
Measurements
OG0000
OG001
Part A: SEA-BCMA 200mg
Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG002
Part A: SEA-BCMA 400mg
Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG003
Part A: SEA-BCMA 800mg
Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG004
Part A: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0043
Title
Denominators
Categories
Title
Measurements
OG00410.0(5.5 to 15.2)
Units
Counts
Participants
OG0004
Title
Denominators
Categories
Title
Measurements
OG0008.4(1.8 to 31.5)
OG001
Part C: SEA-BCMA 800mg and Dexamethasone
Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG002
Part C: SEA-BCMA 1600 mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG0002
OG0012
OG0021
Title
Denominators
Categories
Title
Measurements
OG000NA(4.6 to 35.7)Median could not be calculated due to insufficient number of participants with events.
OG001NA(1.9 to 22.6)Median could not be calculated due to insufficient number of participants with events.
OG0026.5(6.5 to 6.5)
Units
Counts
Participants
OG0004
Title
Denominators
Categories
Title
Measurements
OG0008.3(2.6 to 18.9)
Participants received SEA-BCMA 200 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG002
Part A: SEA-BCMA 400mg
Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG003
Part A: SEA-BCMA 800mg
Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG004
Part A: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0037
OG00422
Title
Denominators
Categories
Title
Measurements
OG0001.7(0.7 to 2.8)
OG0015.9(0.7 to 11.0)
OG0020.7(0.7 to 0.7)
OG0034.4(0.6 to 15.5)
OG0042.1(0.5 to 42.9)
Units
Counts
Participants
OG00020
Title
Denominators
Categories
Title
Measurements
OG0001.7(0.5 to 33.1)
Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG002
Part C: SEA-BCMA 1600 mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG00012
OG0016
OG0025
Title
Denominators
Categories
Title
Measurements
OG0001.6(0.7 to 36.4)
OG0013.2(0.7 to 24.1)
OG0023.5(0.7 to 7.2)
Units
Counts
Participants
OG0005
Title
Denominators
Categories
Title
Measurements
OG00010.1(1.8 to 19.6)
OG002
Part A: SEA-BCMA 400mg
Participants received SEA-BCMA 400 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG003
Part A: SEA-BCMA 800mg
Participants received SEA-BCMA 800 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
OG004
Part A: SEA-BCMA 1600mg
Participants received SEA-BCMA 1600 mg as a monotherapy q2wk IV on Day 1 and 15 of each 28- day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0037
OG00422
Title
Denominators
Categories
Title
Measurements
OG0009.2(3.0 to 9.2)
OG00137.5(11.1 to 37.5)
OG0028.1(0.9 to 15.3)
OG00319.2(1.3 to 45.3)
OG00419.7(0.9 to 44.3)
OG00020
Title
Denominators
Categories
Title
Measurements
OG000NA(0.8 to 33.7)Median could not be calculated due to insufficient number of participants with events.
OG002
Part C: SEA-BCMA 1600 mg and Dexamethasone
Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
Units
Counts
Participants
OG00012
OG0016
OG0025
Title
Denominators
Categories
Title
Measurements
OG00018.0(1.9 to 36.4)
OG001NA(3.7 to 26.0)Median could not be calculated due to insufficient number of participants with events.
OG00212.2(1.2 to 22.2)
OG0005
Title
Denominators
Categories
Title
Measurements
OG000NA(3.3 to 19.6)Median could not be calculated due to insufficient number of participants with events.
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected5 at risk
EG0092 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0082 events1 affected5 at risk
EG0090 events0 affected5 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
1 events
1 affected
7 at risk
EG0041 events1 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0042 events2 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0063 events3 affected12 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0043 events2 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
1 events
1 affected
7 at risk
EG0041 events1 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0042 events1 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected12 at risk
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EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0061 events1 affected12 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected5 at risk
EG0092 events2 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0042 events2 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0072 events1 affected6 at risk
EG0081 events1 affected5 at risk
EG0093 events2 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0043 events3 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0043 events2 affected22 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected5 at risk
1 events
1 affected
7 at risk
EG0043 events3 affected22 at risk
EG0054 events3 affected20 at risk
EG0064 events2 affected12 at risk
EG0072 events2 affected6 at risk
EG0083 events2 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0046 events4 affected22 at risk
EG0053 events3 affected20 at risk
EG0062 events2 affected12 at risk
EG0074 events3 affected6 at risk
EG0081 events1 affected5 at risk
EG0091 events1 affected5 at risk
1 events
1 affected
7 at risk
EG0042 events2 affected22 at risk
EG0052 events2 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected22 at risk
EG0052 events1 affected20 at risk
EG0062 events2 affected12 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0062 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0042 events2 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
3 events
2 affected
7 at risk
EG0044 events3 affected22 at risk
EG0054 events3 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0057 events4 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0045 events5 affected22 at risk
EG0052 events2 affected20 at risk
EG0060 events0 affected12 at risk
EG0073 events1 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected5 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0092 events2 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0082 events1 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0045 events3 affected22 at risk
EG0053 events2 affected20 at risk
EG0062 events2 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0052 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0042 events2 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0042 events1 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0052 events2 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0042 events1 affected22 at risk
EG0050 events0 affected20 at risk
EG0062 events2 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected22 at risk
EG0051 events1 affected20 at risk
EG0062 events2 affected12 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected5 at risk
EG0092 events2 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0092 events2 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected6 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
1 events
1 affected
7 at risk
EG0041 events1 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected22 at risk
EG0056 events4 affected20 at risk
EG0061 events1 affected12 at risk
EG0071 events1 affected6 at risk
EG0081 events1 affected5 at risk
EG0092 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0044 events4 affected22 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected5 at risk
EG0092 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
1 events
1 affected
7 at risk
EG0041 events1 affected22 at risk
EG0054 events2 affected20 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
1 events
1 affected
7 at risk
EG0041 events1 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0052 events2 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0092 events1 affected5 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected12 at risk
EG0071 events1 affected6 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected6 at risk
EG0082 events2 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0092 events2 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected5 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0081 events1 affected5 at risk
EG0090 events0 affected5 at risk
2 events
1 affected
7 at risk
EG0043 events2 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected5 at risk
EG0092 events2 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0092 events2 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0053 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0091 events1 affected5 at risk
1 events
1 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0092 events2 affected5 at risk
0 events
0 affected
7 at risk
EG0048 events5 affected22 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0082 events2 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0041 events1 affected22 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
0 events
0 affected
7 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected5 at risk
EG0090 events0 affected5 at risk
3
OG0047
2
OG00411
1
OG0040
1
OG00412
4
OG0049
2
OG0041
1443.2
± 23.9
OG0043267.7± 26.8
Participants
OG004
12
Title
Measurements
OG000244.8± 15.4
OG001436.0± 10.6
OG0022216.4± NAGeometric Coefficient of variation (CV) could not be calculated as only 1 participant was available for analysis.
OG0032387.9± 41.4
OG0045972.1± 61.0
236.4
± 14.4
OG004494.6± 20.3
Participants
OG004
16
Title
Measurements
OG00044.9± 3.6
OG00162.4± NAGeometric CV could not be calculated as only 1 participant was available for analysis.
OG002213.1± NAGeometric CV could not be calculated as only 1 participant was available for analysis.