A Study of Pembrolizumab (MK-3475) in Combination With St... | NCT02036502 | Trialant
NCT02036502
Sponsor
Merck Sharp & Dohme LLC
Status
Terminated
Last Update Posted
Apr 8, 2021Actual
Enrollment
77Actual
Phase
Phase 1
Conditions
Multiple Myeloma
Interventions
Pembrolizumab
Lenalidomide
Dexamethasone
Carfilzomib
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT02036502
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3475-023
Secondary IDs
ID
Type
Description
Link
2013-003512-44
EudraCT Number
MK-3475-023
Other Identifier
Merck
KEYNOTE-023
Other Identifier
Merck
Brief Title
A Study of Pembrolizumab (MK-3475) in Combination With Standard of Care Treatments in Participants With Multiple Myeloma (MK-3475-023/KEYNOTE-023)
Official Title
A Phase I Multi-Cohort Trial of Pembrolizumab (MK-3475) in Combination With Backbone Treatments for Subjects With Multiple Myeloma
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Mar 2021
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Business Reasons
Expanded Access Info
No
Start Date
Feb 14, 2014Actual
Primary Completion Date
Mar 19, 2020Actual
Completion Date
Mar 19, 2020Actual
First Submitted Date
Jan 13, 2014
First Submission Date that Met QC Criteria
Jan 13, 2014
First Posted Date
Jan 15, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 2, 2021
Results First Submitted that Met QC Criteria
Mar 12, 2021
Results First Posted Date
Apr 8, 2021Actual
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
Mar 12, 2021
Last Update Posted Date
Apr 8, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
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 is a study of pembrolizumab (MK-3475) in combination with lenalidomide and low-dose dexamethasone in participants with refractory or relapsed and refractory Multiple Myeloma (rrMM), and in combination with carfilzomib and low-dose dexamethasone in participants with relapsed or refractory Multiple Myeloma (rMM).
This study was being done to find the maximum tolerated dose (MTD)/maximum administered dose (MAD) and recommended Phase 2 dose (RP2D), and to evaluate the safety and tolerability of pembrolizumab when given in combination with standard of care (SOC) treatments in participants with rrMM or rMM. Preliminary efficacy data will also be assessed. There was no primary hypothesis associated with this study.
On 03-Jul-2017, the United States Food and Drug Administration (US FDA) placed the rrMM cohort of this protocol on clinical hold based on safety data from two other pembrolizumab protocols: MK-3475-183 (NCT02576977) and MK-3475-185 (NCT02579863) presented to the Data Monitoring Committee.
On 15-Sep-2017, the US FDA placed the rMM cohort of this study on partial clinical hold. Enrollment was stopped and will not be reopened. Participants who are deriving clinical benefit were allowed to continue receiving study treatment until protocol-specific end of treatment, and then progress into long term safety and survival follow up. Participants who are not deriving clinical benefit, must stop study treatment and move into the long term safety and survival follow up.
Detailed Description
Not provided
Conditions Module
Conditions
Multiple Myeloma
Keywords
PD1
PD-1
PDL1
PD-L1
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
77Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1:pembro 2mg/kg+len 25mg+dex 40 mg
Experimental
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
Biological: Pembrolizumab
Drug: Lenalidomide
Drug: Dexamethasone
Part 1:pembro 2mg/kg+len 10 mg+dex 40 mg
Experimental
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
Biological: Pembrolizumab
Drug: Lenalidomide
Drug: Dexamethasone
Part 2:pembro 200 mg+len 25 mg+dex 40 mg
Experimental
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
Biological: Pembrolizumab
Drug: Lenalidomide
Drug: Dexamethasone
Part 2:pembro 200 mg+len 25 mg+dex 20 mg
Experimental
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28- day cycle).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pembrolizumab
Biological
Intravenous (IV) infusion
Part 1:pembro 2mg/kg+len 10 mg+dex 40 mg
Part 1:pembro 2mg/kg+len 25mg+dex 40 mg
Part 2:pembro 200 mg+len 10 mg+dex 40 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0)
DLTs were assessed during Cycle 1 (28 days) and were defined as the occurrence of any of the following judged by the investigator to be possibly, probably or definitely related to study drug: Grade (Gr) 4 non-hematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days; Gr 3 non-hematologic toxicity lasting >3 days; Gr 3 non-hematologic laboratory value if: medical intervention was required, abnormality led to hospitalization, was renal or liver function related, or persisted for >1 week; Gr 3/4 febrile neutropenia; thrombocytopenia <25,000 cells/mm^3 (associated with bleeding requiring platelet transfusion or life-threatening bleeding); Gr 5 toxicity; or delay of >1 week in initiating Cycle 2 or unable to complete 80% of treatment during the first course of therapy due to drug-related toxicity. DLTs for the rMM cohort were any drug-related adverse events that cannot be managed by dose modification. DLTs are reported for the maximum tolerated dose.
Up to 28 days in Cycle 1
Number of Participants Who Experienced One or More Adverse Events (AEs)
An adverse event was defined as any untoward medical occurrence in a participant administered study treatment and did not necessarily have a causal relationship with this treatment. An adverse event could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the study treatment was also an adverse event.
Up to approximately 72.7 months
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
An adverse event was defined as any untoward medical occurrence in a participant administered study treatment and did not necessarily have a causal relationship with this treatment. An adverse event could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the study treatment was also an adverse event.
Secondary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) Evaluated According to the International Myeloma Working Group (IMWG) 2006 Response Criteria by Confirmed Investigator Assessment
ORR was the percentage of the participants who achieved at least a partial response (stringent complete response [sCR]+complete response [CR]+very good partial response [VGPR]+partial response [PR]). CR=negative immunofixation of serum and urine+no tissue plasmacytomas+≤5% plasmacytomas in bone marrow; sCR=stringent complete response, CR+normal free light chain (FLC) ratio+no clonal cells in bone marrow; VGPR=serum+urine M-protein detectable by immunofixation but not electrophoresis OR ≥90% reduction in serum M-protein+urine M-protein <100 mg/24 hour(hr); PR = ≥50% reduction of serum M-protein+reduction in 24hr urinary M-protein by ≥90% or to <200 mg/24 hrs.
Other Outcomes
Measure
Description
Time Frame
Duration of Response (DOR) Evaluated According to the International Myeloma Working Group (IMWG) 2006 Response Criteria by Confirmed Investigator Assessment
DOR was the time from first evidence of response (stringent complete response [sCR]+complete response [CR], very good partial response [VGPR], partial response [PR]) until disease progression (PD) or death. CR=negative immunofixation of serum and urine+no tissue plasmacytomas+≤5% plasmacytomas in bone marrow; sCR=stringent complete response, CR+normal free light chain (FLC) ratio+no clonal cells in bone marrow; VGPR=serum+urine M-protein detectable by immunofixation but not electrophoresis OR ≥90% reduction in serum M-protein+urine M-protein <100 mg/24 hour(hr); PR = ≥50% reduction of serum M-protein+reduction in 24hr urinary M-protein by ≥90% or to <200 mg/24 hrs. PD=≥1 of the following: ≥25% increase from baseline serum/urine M-protein; hypercalcemia; increase between involved/uninvolved FLC levels; ≥10% bone marrow plasma cells; new or increase in the size of existing bone lesions or tissue plasmacytomas. DOR was calculated using the Kaplan-Meier method for censored data.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
All Participants:
Confirmed diagnosis of multiple myeloma (MM)
MM with measurable disease
Archival or newly obtained bone marrow material available. In addition, for participants in the United States (US) and Canada, able to provide newly obtained bone marrow aspirate for biomarker analysis.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function
Female participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study treatment
Male participants must agree to use a latex condom during sexual contact with females of childbearing potential even if they have had a successful vasectomy starting with the first dose of study treatment through 120 days after the last dose of study treatment
Able to swallow capsules and able to take or tolerate oral medications on a continuous basis
Dose Determination Arm, Dose Confirmation Arm and Cohort 1 Participants:
Must have undergone prior treatment with ≥ 2 treatment lines of anti-myeloma therapy and must have failed their last line of treatment
Prior anti-myeloma treatments must have included an immunomodulatory (IMiD) treatment (lenalidomide, pomalidomide or thalidomide) AND proteasome inhibitor (bortezomib or carfilzomib) alone or in combination and participant must have failed therapy with an IMiD OR proteasome inhibitor
Must agree to follow the regional requirements for lenalidomide counseling, pregnancy testing, and birth control; willing and able to comply with the regional requirements (for example, periodic pregnancy tests and safety labs)
Cohort 2 Participants:
MM with relapsing or refractory disease at study entry
Received prior treatment with 1 to 3 lines for MM
Achieved a partial response to at least one prior regimen (defined as ≥50% decrease in tumor burden)
Left ventricular ejection fraction of at least 40%
Exclusion Criteria:
All Participants:
Currently participating in and receiving study therapy or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study treatment
History of repeated infections; primary amyloidosis; hyperviscosity; plasma cell leukemia; polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome or Waldenström's macroglobulinemia
Diagnosis of immunosuppressive disorder or on any other immunosuppressive therapy within 7 days prior to the first dose of study treatment
Received a prior monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e. ≤ Grade 1 or at baseline) from a baseline AE or a Grade 1 AE associated with agents administered more than 4 weeks earlier
Prior anti-MM therapy (including dexamethasone), targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or not recovered from AEs due to a previously administered agent
An additional malignancy that is progressing or requires active treatment within the last 5 years
Active autoimmune disease or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
Active infection requiring intravenous systemic therapy
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 120 days after the last dose of study treatment
Prior therapy with an anti-programmed cell death (PD)-1, anti-PD ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137 antibody, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection
Clinically significant coagulopathy
Has had or is planning for allogeneic stem cell transplant
Autologous stem cell transplant within 12 weeks before the first infusion
History of Grade 4 rash associated with thalidomide treatment
Known hypersensitivity to thalidomide, lenalidomide or pomalidomide
Received a live vaccine within 30 days of planned start of study treatment
Dose Determination Arm, Dose Confirmation Arm and Cohort 1 Participants:
Clinically active central nervous system (CNS) involvement
Known gastrointestinal disease that may significantly alter the absorption of lenalidomide
Unable or unwilling to undergo antithrombotic prophylactic treatment
Known symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Cohort 2 Participants:
Smoldering MM (SMM), monoclonal gammopathy of undetermined significance (MGUS), plasma cell leukemia or Waldenström's macroglobulinemia
Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to the first dose of study treatment
Myocardial infarction within 4 months prior to randomization, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless participant has a pacemaker.
Known history of allergy to CAPTISOL® (a cyclodextrin derivative used to solubilize carfilzomib)
Hypersensitivity to carfilzomib, bortezomib, boron, or mannitol
Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to pre-existing pulmonary or cardiac impairment
Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to the first dose of study treatment
Pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to the first dose of study treatment
This study included 3 parts: (1) dose determination/escalation (2) dose confirmation and (3) dose expansion. The study included a pooled analysis of efficacy for participants receiving any dose of pembro+len+dex combined or pembro+carfilzomib (carf)+dex randomized by disease cohort.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
FG001
Periods
Title
Milestones
Reasons Not Completed
Part 1:Dose Determination/Escalation
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
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_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Mar 10, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Canada
France
Spain
United States
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
Biological: Pembrolizumab
Drug: Lenalidomide
Drug: Dexamethasone
Part 2:pembro 200 mg+len 10 mg+dex 40 mg
Experimental
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
Biological: Pembrolizumab
Drug: Lenalidomide
Drug: Dexamethasone
Part 3:pembro 200 mg+len 25 mg+dex 40 mg
Experimental
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W weekly during each 28-day cycle.
Biological: Pembrolizumab
Drug: Lenalidomide
Drug: Dexamethasone
Part 3:pembro 200 mg+len 25 mg+dex 20 mg
Experimental
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W weekly during each 28-day cycle.
Biological: Pembrolizumab
Drug: Lenalidomide
Drug: Dexamethasone
Part 3:pembro 200 mg+carf 56 mg/m^2+dex 20 mg
Experimental
Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg once or twice weekly (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
Biological: Pembrolizumab
Drug: Dexamethasone
Drug: Carfilzomib
Part 2:pembro 200 mg+len 25 mg+dex 20 mg
Part 2:pembro 200 mg+len 25 mg+dex 40 mg
Part 3:pembro 200 mg+carf 56 mg/m^2+dex 20 mg
Part 3:pembro 200 mg+len 25 mg+dex 20 mg
Part 3:pembro 200 mg+len 25 mg+dex 40 mg
MK-3475
KEYTRUDA®
Lenalidomide
Drug
Oral capsule
Part 1:pembro 2mg/kg+len 10 mg+dex 40 mg
Part 1:pembro 2mg/kg+len 25mg+dex 40 mg
Part 2:pembro 200 mg+len 10 mg+dex 40 mg
Part 2:pembro 200 mg+len 25 mg+dex 20 mg
Part 2:pembro 200 mg+len 25 mg+dex 40 mg
Part 3:pembro 200 mg+len 25 mg+dex 20 mg
Part 3:pembro 200 mg+len 25 mg+dex 40 mg
REVLIMID®
Dexamethasone
Drug
Oral tablet IV infusion
Part 1:pembro 2mg/kg+len 10 mg+dex 40 mg
Part 1:pembro 2mg/kg+len 25mg+dex 40 mg
Part 2:pembro 200 mg+len 10 mg+dex 40 mg
Part 2:pembro 200 mg+len 25 mg+dex 20 mg
Part 2:pembro 200 mg+len 25 mg+dex 40 mg
Part 3:pembro 200 mg+carf 56 mg/m^2+dex 20 mg
Part 3:pembro 200 mg+len 25 mg+dex 20 mg
Part 3:pembro 200 mg+len 25 mg+dex 40 mg
DECADRON®
Carfilzomib
Drug
IV infusion
Part 3:pembro 200 mg+carf 56 mg/m^2+dex 20 mg
KYPROLIS®
Up to approximately 72.7 months
Up to approximately 72.7 months
Disease Control Rate (DCR) Evaluated According to the International Myeloma Working Group (IMWG) 2006 Response Criteria by Confirmed Investigator Assessment
DCR was the percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or stable disease (SD) ≥12 weeks prior to evidence of disease progression (PD). CR=negative immunofixation of serum and urine+no tissue plasmacytomas+ ≤5% plasmacytomas in bone marrow; sCR=stringent complete response, CR+normal free light chain (FLC) ratio+no clonal cells in bone marrow; VGPR=serum+urine M-protein detectable by immunofixation but not on electrophoresis OR ≥90% reduction in serum M-protein+urine M-protein <100 mg/24 hour(hr); PR=≥50% reduction of serum M-protein+reduction in 24 hr urinary M-protein by ≥90% or to <200 mg/24 hrs; SD=not meeting the criteria for CR, VGPR, PR, or PD. PD=≥1 of the following: ≥25% increase from baseline in serum/urine M-protein; hypercalcemia; increase in FLC ratio; ≥10% bone marrow plasma cells; new or increase in the size of existing bone lesions or tissue plasmacytomas.
Up to approximately 72.7 months
Up to approximately 72.7 months
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. OS was calculated from product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
Up to approximately 72.7 months
Progression Free Survival (PFS) Evaluated According to the International Myeloma Working Group (IMWG) 2006 Response Criteria by Confirmed Investigator Assessment
PFS was defined as the time from randomization to the first documented disease progression (PD) or death due to any cause. PD= ≥1 of the following: ≥25% increase from baseline in serum/urine M-protein; hypercalcemia; increase in FLC ratio; ≥10% bone marrow plasma cells; new or increase in the size of existing bone lesions or tissue plasmacytomas. The median PFS was calculated from the Kaplan-Meier method for censored data.
Up to approximately 72.7 months
Time to Progression (TTP) Evaluated According to the International Myeloma Working Group (IMWG) 2006 Response Criteria by Confirmed Investigator Assessment
TTP was defined as the time from the first dose to first documented disease progression (PD) or death due to any cause. PD= ≥1 of the following: ≥25% increase from baseline in serum/urine M-protein; hypercalcemia; increase in FLC ratio; ≥10% bone marrow plasma cells; new or increase in the size of existing bone lesions or tissue plasmacytomas.
Up to approximately 72.7 months
Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
FG002
Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
FG003
Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
FG004
Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
FG005
Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
FG006
Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
FG007
Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg
Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
FG0006 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Treated
FG0006 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0006 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Type
Comment
Reasons
Death
FG0003 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Study Terminated by Sponsor
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Not treated
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 2:Dose Confirmation
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0026 subjectsParticipants added to study for dose confirmation.
FG0032 subjectsParticipants added to study for dose confirmation.
FG0041 subjectsParticipants added to study for dose confirmation.
FG0050 subjects
FG0060 subjects
FG0070 subjects
Treated
FG0000 subjects
FG0010 subjects
FG0026 subjects
FG0031 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0026 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Study Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG003
Part 3:Dose Expansion
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00547 subjectsParticipants added to study for dose expansion
FG0061 subjectsParticipants added to study for dose expansion
FG00710 subjectsParticipants added to study for dose expansion
Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The analysis population consisted of all randomized participants
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
BG001
Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
BG002
Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
BG003
Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
BG004
Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
BG005
Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
BG006
Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
BG007
Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg
Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0014
BG0026
BG0032
BG0041
BG00547
BG0061
BG00710
BG00877
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
0 to 17 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0013
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 Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0)
DLTs were assessed during Cycle 1 (28 days) and were defined as the occurrence of any of the following judged by the investigator to be possibly, probably or definitely related to study drug: Grade (Gr) 4 non-hematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days; Gr 3 non-hematologic toxicity lasting >3 days; Gr 3 non-hematologic laboratory value if: medical intervention was required, abnormality led to hospitalization, was renal or liver function related, or persisted for >1 week; Gr 3/4 febrile neutropenia; thrombocytopenia <25,000 cells/mm^3 (associated with bleeding requiring platelet transfusion or life-threatening bleeding); Gr 5 toxicity; or delay of >1 week in initiating Cycle 2 or unable to complete 80% of treatment during the first course of therapy due to drug-related toxicity. DLTs for the rMM cohort were any drug-related adverse events that cannot be managed by dose modification. DLTs are reported for the maximum tolerated dose.
All DLT-evaluable participants in Parts 1 and 2 who received ≥1 dose of study treatment, completed Cycle 1 (28 days), or who had a DLT during the DLT evaluation period. Per protocol, DLT was not planned to be evaluated in Part 3.
Posted
Count of Participants
Participants
Up to 28 days in Cycle 1
ID
Title
Description
OG000
Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
OG001
Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG002
Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG003
Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
OG004
Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG005
Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg
Units
Counts
Participants
OG0006
OG0013
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0003
OG0010
OG0020
OG003
Primary
Number of Participants Who Experienced One or More Adverse Events (AEs)
An adverse event was defined as any untoward medical occurrence in a participant administered study treatment and did not necessarily have a causal relationship with this treatment. An adverse event could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the study treatment was also an adverse event.
All participants who received ≥1 dose of study treatment.
Posted
Count of Participants
Participants
Up to approximately 72.7 months
ID
Title
Description
OG000
Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
OG001
Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
Primary
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
An adverse event was defined as any untoward medical occurrence in a participant administered study treatment and did not necessarily have a causal relationship with this treatment. An adverse event could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the study treatment was also an adverse event.
All participants who received ≥1 dose of study treatment.
Posted
Count of Participants
Participants
Up to approximately 72.7 months
ID
Title
Description
OG000
Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
OG001
Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
Secondary
Objective Response Rate (ORR) Evaluated According to the International Myeloma Working Group (IMWG) 2006 Response Criteria by Confirmed Investigator Assessment
ORR was the percentage of the participants who achieved at least a partial response (stringent complete response [sCR]+complete response [CR]+very good partial response [VGPR]+partial response [PR]). CR=negative immunofixation of serum and urine+no tissue plasmacytomas+≤5% plasmacytomas in bone marrow; sCR=stringent complete response, CR+normal free light chain (FLC) ratio+no clonal cells in bone marrow; VGPR=serum+urine M-protein detectable by immunofixation but not electrophoresis OR ≥90% reduction in serum M-protein+urine M-protein <100 mg/24 hour(hr); PR = ≥50% reduction of serum M-protein+reduction in 24hr urinary M-protein by ≥90% or to <200 mg/24 hrs.
The analysis population included all participants who received ≥1 dose of study treatment. The analysis was pre-specified to be a pooled analysis of all participants grouped by disease cohort (rrMM or rMM) and treatment combination (irrespective of dose); therefore data by individual dose were not analyzed.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to approximately 72.7 months
ID
Title
Description
OG000
Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
OG001
Secondary
Disease Control Rate (DCR) Evaluated According to the International Myeloma Working Group (IMWG) 2006 Response Criteria by Confirmed Investigator Assessment
DCR was the percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or stable disease (SD) ≥12 weeks prior to evidence of disease progression (PD). CR=negative immunofixation of serum and urine+no tissue plasmacytomas+ ≤5% plasmacytomas in bone marrow; sCR=stringent complete response, CR+normal free light chain (FLC) ratio+no clonal cells in bone marrow; VGPR=serum+urine M-protein detectable by immunofixation but not on electrophoresis OR ≥90% reduction in serum M-protein+urine M-protein <100 mg/24 hour(hr); PR=≥50% reduction of serum M-protein+reduction in 24 hr urinary M-protein by ≥90% or to <200 mg/24 hrs; SD=not meeting the criteria for CR, VGPR, PR, or PD. PD=≥1 of the following: ≥25% increase from baseline in serum/urine M-protein; hypercalcemia; increase in FLC ratio; ≥10% bone marrow plasma cells; new or increase in the size of existing bone lesions or tissue plasmacytomas.
The analysis population included all participants who received ≥1 dose of study treatment. The analysis was pre-specified to be a pooled analysis of all participants grouped by disease cohort (rrMM or rMM) and treatment combination (irrespective of dose); therefore data by individual dose were not analyzed.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to approximately 72.7 months
ID
Title
Description
OG000
Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
Other Pre-specified
Duration of Response (DOR) Evaluated According to the International Myeloma Working Group (IMWG) 2006 Response Criteria by Confirmed Investigator Assessment
DOR was the time from first evidence of response (stringent complete response [sCR]+complete response [CR], very good partial response [VGPR], partial response [PR]) until disease progression (PD) or death. CR=negative immunofixation of serum and urine+no tissue plasmacytomas+≤5% plasmacytomas in bone marrow; sCR=stringent complete response, CR+normal free light chain (FLC) ratio+no clonal cells in bone marrow; VGPR=serum+urine M-protein detectable by immunofixation but not electrophoresis OR ≥90% reduction in serum M-protein+urine M-protein <100 mg/24 hour(hr); PR = ≥50% reduction of serum M-protein+reduction in 24hr urinary M-protein by ≥90% or to <200 mg/24 hrs. PD=≥1 of the following: ≥25% increase from baseline serum/urine M-protein; hypercalcemia; increase between involved/uninvolved FLC levels; ≥10% bone marrow plasma cells; new or increase in the size of existing bone lesions or tissue plasmacytomas. DOR was calculated using the Kaplan-Meier method for censored data.
The analysis population included all participants who received ≥1 dose of study treatment and demonstrated at least a partial response. The analysis was pre-specified to be a pooled analysis of all participants grouped by disease cohort (rrMM or rMM) and treatment combination (irrespective of dose); therefore data by individual dose were not analyzed.
Posted
Median
95% Confidence Interval
Months
Up to approximately 72.7 months
ID
Title
Description
OG000
Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
Other Pre-specified
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. OS was calculated from product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
The analysis population included all participants who received ≥1 dose of study treatment. The analysis was pre-specified to be a pooled analysis of all participants grouped by disease cohort (rrMM or rMM) and treatment combination (irrespective of dose); therefore data by individual dose were not analyzed.
Posted
Median
95% Confidence Interval
Months
Up to approximately 72.7 months
ID
Title
Description
OG000
Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
OG001
Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG002
Other Pre-specified
Progression Free Survival (PFS) Evaluated According to the International Myeloma Working Group (IMWG) 2006 Response Criteria by Confirmed Investigator Assessment
PFS was defined as the time from randomization to the first documented disease progression (PD) or death due to any cause. PD= ≥1 of the following: ≥25% increase from baseline in serum/urine M-protein; hypercalcemia; increase in FLC ratio; ≥10% bone marrow plasma cells; new or increase in the size of existing bone lesions or tissue plasmacytomas. The median PFS was calculated from the Kaplan-Meier method for censored data.
The analysis population included all participants who received ≥1 dose of study treatment. The analysis was pre-specified to be a pooled analysis of all participants grouped by disease cohort (rrMM or rMM) and treatment combination (irrespective of dose); therefore data by individual dose were not analyzed.
Posted
Median
95% Confidence Interval
Months
Up to approximately 72.7 months
ID
Title
Description
OG000
Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
OG001
Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
Other Pre-specified
Time to Progression (TTP) Evaluated According to the International Myeloma Working Group (IMWG) 2006 Response Criteria by Confirmed Investigator Assessment
TTP was defined as the time from the first dose to first documented disease progression (PD) or death due to any cause. PD= ≥1 of the following: ≥25% increase from baseline in serum/urine M-protein; hypercalcemia; increase in FLC ratio; ≥10% bone marrow plasma cells; new or increase in the size of existing bone lesions or tissue plasmacytomas.
All participants who received ≥1 dose of study treatment. The analysis was pre-specified to be a pooled analysis of participants grouped by disease cohort (rrMM or rMM)/treatment (irrespective of dose). There were insufficient data available to conduct the TTP analyses.
Posted
Up to approximately 72.7 months
ID
Title
Description
OG000
Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
OG001
Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
Time Frame
Up to approximately 72.7 months
Description
The analysis population for adverse events (AEs) consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to study treatment are excluded. All-cause mortality is reported for all randomized participants.
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 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
3
6
2
6
6
6
EG001
Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
3
4
3
3
3
3
EG002
Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
1
6
2
6
6
6
EG003
Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
0
2
1
1
1
1
EG004
Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
0
1
1
1
1
1
EG005
Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
31
47
19
45
44
45
EG006
Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
0
1
0
1
1
1
EG007
Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg
Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
6
10
9
10
10
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected45 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected10 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cardiac amyloidosis
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypopituitarism
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Death
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Liver injury
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Venoocclusive liver disease
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0013 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Sepsis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Septic shock
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Varicella
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
West Nile viral infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Transaminases increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0005 events4 affected6 at risk
EG0010 events0 affected3 at risk
EG0024 events2 affected6 at risk
EG0031 events1 affected1 at risk
EG0040 events0 affected1 at risk
EG00532 events17 affected45 at risk
EG0061 events1 affected1 at risk
EG00711 events5 affected10 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG00018 events4 affected6 at risk
EG0014 events2 affected3 at risk
EG00216 events2 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG00036 events4 affected6 at risk
EG0011 events1 affected3 at risk
EG0025 events2 affected6 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cardiac amyloidosis
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Blindness
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dry eye
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vision blurred
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0023 events2 affected6 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0003 events2 affected6 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0004 events1 affected6 at risk
EG0012 events2 affected3 at risk
EG00216 events5 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Asthenia
General disorders
MedDRA 22.1
Systematic Assessment
EG0004 events1 affected6 at risk
EG0012 events1 affected3 at risk
EG0024 events2 affected6 at risk
EG003
Chest pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0023 events2 affected6 at risk
EG003
Face oedema
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0025 events3 affected6 at risk
EG003
Oedema
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0025 events1 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0013 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0012 events1 affected3 at risk
EG0023 events1 affected6 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Tongue fungal infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG00011 events2 affected6 at risk
EG0010 events0 affected3 at risk
EG0023 events3 affected6 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0002 events1 affected6 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Platelet count decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0006 events2 affected6 at risk
EG0010 events0 affected3 at risk
EG00213 events2 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected6 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0011 events1 affected3 at risk
EG0024 events3 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Bone swelling
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0025 events2 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG00210 events4 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG00212 events3 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0023 events3 affected6 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected6 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Tremor
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Nephritis
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0024 events2 affected6 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events1 affected3 at risk
EG0027 events2 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0023 events1 affected6 at risk
EG003
Pharyngeal erythema
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected3 at risk
EG0024 events2 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0028 events2 affected6 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Primary hypothyroidism
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Excessive cerumen production
Ear and labyrinth disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Thyroiditis
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Eyelid sensory disorder
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Aerophagia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected6 at risk
EG003
Abdominal wall haematoma
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Chills
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0024 events1 affected6 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Peripheral swelling
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Swelling face
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Injection site bruising
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0002 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Candida infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cystitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Otitis media
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Viral infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Ear infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Skin infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Eye contusion
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Face injury
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0005 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood urine present
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Monocyte count increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Serum ferritin decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Transaminases increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Mental impairment
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Depression
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Nipple pain
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected3 at risk
EG0026 events1 affected6 at risk
EG003
Lower respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Haematoma
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Flushing
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Enrollment of participants into this study was stopped after the FDA implemented a clinical hold after determining the risks of pembrolizumab + pomalidomide or lenalidomide outweighed any potential benefit for participants with multiple myeloma.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
OG006
Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
OG007
Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg
Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
1
OG0041
OG0050
OG0060
OG0070
0
OG0040
OG002
Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG003
Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
OG004
Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG005
Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
OG006
Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
OG007
Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg
Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
Units
Counts
Participants
OG0006
OG0013
OG0026
OG0031
OG0041
OG00545
OG0061
OG00710
Title
Denominators
Categories
Title
Measurements
OG0006
OG0013
OG0026
OG0031
OG0041
OG00545
OG0061
OG00710
OG002
Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG003
Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
OG004
Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG005
Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
OG006
Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
OG007
Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg
Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
Units
Counts
Participants
OG0006
OG0013
OG0026
OG0031
OG0041
OG00545
OG0061
OG00710
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0054
OG0060
OG0076
Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG002
Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG003
Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
OG004
Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG005
Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
OG006
Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
OG007
Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg
Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
OG008
Pooled rrMM Cohort
Participants from Parts 1 and 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received any dose combination of pembrolizumab Q2W (Days 1 and 15) in combination with lenalidomide and dexamethasone Q1W during each 28-day cycle.
OG009
Pooled rMM Cohort
Participants from Part 2 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG00863
OG00910
Title
Denominators
Categories
Title
Measurements
OG00830.2(19.2 to 43.0)
OG00970.0(34.8 to 93.3)
OG001
Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG002
Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG003
Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
OG004
Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG005
Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
OG006
Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
OG007
Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg
Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
OG008
Pooled rrMM Cohort
Participants from Parts 1 and 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received any dose combination of pembrolizumab Q2W (Days 1 and 15) in combination with lenalidomide and dexamethasone Q1W during each 28-day cycle.
OG009
Pooled rMM Cohort
Participants from Part 2 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG00863
OG00910
Title
Denominators
Categories
Title
Measurements
OG00884.1(72.7 to 92.1)
OG009100.0(69.2 to 100.0)
OG001
Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg
Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG002
Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG003
Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
OG004
Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG005
Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
OG006
Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
OG007
Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg
Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
OG008
Pooled rrMM Cohort
Participants from Parts 1 and 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received any dose combination of pembrolizumab Q2W (Days 1 and 15) in combination with lenalidomide and dexamethasone Q1W during each 28-day cycle.
OG009
Pooled rMM Cohort
Participants from Part 2 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG00819
OG0097
Title
Denominators
Categories
Title
Measurements
OG00816.4(7.7 to 36.8)
OG00914.1(8.8 to 17.7)
Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG003
Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
OG004
Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG005
Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
OG006
Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
OG007
Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg
Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
OG008
Pooled rrMM Cohort
Participants from Parts 1 and 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received any dose combination of pembrolizumab Q2W (Days 1 and 15) in combination with lenalidomide and dexamethasone Q1W during each 28-day cycle.
OG009
Pooled rMM Cohort
Participants from Part 2 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG00863
OG00910
Title
Denominators
Categories
Title
Measurements
OG00829.0(17.8 to 42.4)
OG00922.5(2.0 to NA)OS upper limit could not be estimated due to insufficient number of events at the time of final analysis.
OG002
Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG003
Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
OG004
Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG005
Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
OG006
Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
OG007
Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg
Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
OG008
Pooled rrMM Cohort
Participants from Parts 1 and 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received any dose combination of pembrolizumab Q2W (Days 1 and 15) in combination with lenalidomide and dexamethasone Q1W during each 28-day cycle.
OG009
Pooled rMM Cohort
Participants from Part 2 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG00863
OG00910
Title
Denominators
Categories
Title
Measurements
OG0085.6(2.8 to 7.2)
OG00914.3(2.0 to 19.6)
OG002
Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG003
Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
OG004
Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg
Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
OG005
Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
OG006
Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg
Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
OG007
Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg
Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
OG008
Pooled rrMM Cohort
Participants from Parts 1 and 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received any dose combination of pembrolizumab Q2W (Days 1 and 15) in combination with lenalidomide and dexamethasone Q1W during each 28-day cycle.
OG009
Pooled rMM Cohort
Participants from Part 2 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab Q3W in combination with carfilzomib 56 mg/m^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.