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| ID | Type | Description | Link |
|---|---|---|---|
| H9S-MC-JDCG | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate an investigational drug called tabalumab in participants with Multiple Myeloma (MM) who have tried at least one other therapy in the past. Tabalumab will be given in combination with standard doses of two other drugs that are often used to treat MM. Study doctors will collect information about the effectiveness and side effects of this therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 mg Tabalumab+Dexamethasone (Dex)+Bortezomib (BTZ) | Experimental | Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 milligram per square meter (mg/m^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for a minimum 8 cycles. All treatment may continue past 8 cycles. |
|
| 300 mg Tabalumab+Dexamethasone+Bortezomib | Experimental | Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for a minimum 8 cycles. Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles. All treatment may continue past 8 cycles. |
|
| Placebo Comparator: Placebo + Dexamethasone + Bortezomib | Placebo Comparator | Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for a minimum 8 cycles. Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles. All treatment may continue past 8 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Administered IV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS is defined as the time from date of first dose to the first observation of disease progression or death due to any cause. If a participant does not have a complete baseline disease assessment, then the PFS time is censored at the enrollment date, regardless of whether or not objectively determined disease progression (Increase of > 25% from lowest response in serum M component, urine M component, bone marrow plasma cell percentage, development of bone lesions) or death has been observed for the participant. If a participant is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time is censored at the last complete objective progression-free disease assessment date. | Baseline up to Objective Disease Progression or Death From Any Cause (assessed up to 9 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival is the duration from enrollment to death from any cause. For participants who were alive, overall survival was censored at the last contact. | Baseline to Death From Any Cause (assessed up to 19 months) |
| Time to First Skeletal-Related Event (SRE) |
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Inclusion Criteria:
Exclusion Criteria:
Are enrolled in or discontinued from a clinical trial of any drug or device within 21 days prior to the first dose of assigned study treatment
Have had less than a minimal response or have had progressive disease within 60 days of most recent therapy with a proteasome inhibitor
Plan to proceed to autologous transplant for consolidation after participation in this trial
Have an active infection or ongoing treatment for systemic infection ("ongoing treatment" does not include prophylactic anti-infectives),, chest x-ray suggestive of tuberculosis, or history/risk of chronic/latent infection that may reactivate in the presence of study therapy
Have any of the following:
Have had significant allergy to human/humanized monoclonal antibodies that, in the opinion of the investigator, poses an unacceptable risk to the participants
Have known hypersensitivity or contraindication to any of the study therapies or excipients
Prior allogeneic hematopoietic stem cell transplant
Prior therapy with experimental agents targeting B-cell activating factor (BAFF), including LY2127399
Have corrected QT (QTc) interval >500 millisecond (msec) on baseline 12-lead electrocardiogram (ECG)
Have Waldenstrom's macroglobulinemia
History of malignancy with adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer, are eligible regardless of the time of diagnosis/treatment
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tucson | Arizona | 85715 |
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.
This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Completers are defined as participants who died or had disease progression or completed treatment or did not complete treatment and were followed for survival data.
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| ID | Title | Description |
|---|---|---|
| FG000 | 100 mg Tabalumab+Dexamethasone+Bortezomib | Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib (BTZ) 1.3 milligram per square meter (mg/m^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dexamethasone |
| Drug |
Administered orally |
|
| Bortezomib | Drug | Administered SQ |
|
| Tabalumab | Biological | Administered IV |
|
|
Time to first SRE is defined as time from randomization to any one of the following related to multiple myeloma: New Pathological Fracture, Spinal Cord Compression, Surgery to the Bone, Radiation to the Bone collected until participant death, study closure or lost to follow up. Participants not known to have had an SRE at the time of the analysis were censored at the date of their last complete documented assessment for SRE. |
| Baseline to Date of First Skeletal Related Event (assessed up to 19 months) |
| Number of Participants With >30% Reduction in Brief Pain Inventory (BPI) - Worst Pain Score | BPI is assessed by 7 questions rated "0" for "no pain" and higher numbers indicated more pain. | Baseline through End of Treatment (19 months) |
| Time to Progression (TTP) | Time to progression is defined as the time from the date of randomization to the date of first observed objective progression or death due to study disease. Time to progression will be censored as for PFS for those participants not known to have progressed or that died from other causes. | Baseline to Objective Disease Progression or Death (assessed up to 9 months) |
| Duration of Response (DoR) | DOR is measured by the International Myeloma Working Group Uniform Response Criteria: from the date of first evidence of a confirmed response to the date of objective progression or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, the DOR time will be censored at the last complete objective progression-free disease assessment date. Progressive disease is an increase of 25% from baseline in Serum M, Urine M, bone marrow plasma cell increase of 10 %, development of new bone lesions, development of new soft tissue plasmacytomas or bone lesions, hypercalcemia >11.5 milligrams per deciliter, decrease in hemoglobin of 2 grams per deciliter, rise in serum creatinine by 2 mg/deciliter. | Time from Response to Objective Disease Progression (assessed up to 38 months) |
| Time to Next Treatment (TNT) | TNT is defined as the time from the date of randomization to the date of initiation of the first poststudy treatment course of anticancer therapy or death from any cause. Time to next treatment will be censored at the date of the last visit for participant who did not initiate additional anticancer therapy. | Baseline to Initiation of New Cancer Treatment or Death From Any Cause (18 Months) |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab | Maximum Concentration (Cmax) of Tabalumab. | Cycle (C)1 Day (D)1: Predose, 3O minutes, 2 hours Postdose; C1 D4, 8, 11: Predose, (D11 only, 30 minutes Postdose); C2 and C6-C10 D1: Predose and immediately Postdose; C2 D 4, 8, 11: Anytime |
| PK: Time to Maximum Plasma Concentration (Tmax) of Tabalumab | C1 D1: Predose, 3O minutes, 2 hours Postdose; C1 D4, 8, 11: Predose, (D11 only, 30 minutes Postdose); C2 and C6-C10 D1: Predose and immediately Postdose; C2 D 4, 8, 11: Anytime |
| PK: Area Under the Curve Over the Dosing Interval (AUC-T) for Tabalumab | C1 D1: Predose, 3O minutes, 2 hours Postdose; C1 D4, 8, 11: Predose, (D11 only, 30 minutes Postdose); C2 and C6-C10 D1: Predose and immediately Postdose; C2 D 4, 8, 11: Anytime |
| Number of Participants Developing Anti-tabalumab Antibodies | Baseline through Cycle 8 |
| Participants With Best Overall Response (BOR) in Each Category | Stringent Complete Response-Complete Response and normal free light chain ration and no clonal cells in bone marrow Complete Response- no monoclonal protein (mp) in blood, no serum or urine mp, less than 5% plasma cells in bone marrow Very Good Partial Response-more than 90% decrease in mp and urine protein Partial Response- over 50% decrease in serum mp Stable Disease- less than 25 percent decrease of monoclonal protein Progressive Disease- 25% increase compared to lowest value of serum mp, urine mp, no measurable mp | Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (28 Months) |
| Number of Participants With a Given Best Objective Myeloma Response (Quality of Response [QoR]) | Response categories in order of decreasing quality are: Stringent Complete Response(sCR),Complete Response(CR), Very Good Partial Response(VGPR),Partial Response(PR),Minimal Response(MR),Stable Disease(SD), or Progressive Disease(PD), according to the International Uniform Response Criteria for Multiple Myeloma.SCR:normal free light chain ration and no clonal cells in bone marrow;CR-no monoclonal protein(mp) in blood, no serum/urine,<5% plasma cells in bone marrow; VGPR-more than 90% decrease in mp and urine protein; PR->50% decrease in serum MP;SD-<25% decrease in mp; PD-25% increase compared to lowest value of serum mp, urine mp and no measurable mp. | Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (up to 28 Months) |
| Overall Response Rate (ORR) | Overall Response Rate (ORR) is the percentage of participants that had a response. | Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (28 Months) |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fullerton | California | 92835 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Los Angeles | California | 90095 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Santa Barbara | California | 93105 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Grand Junction | Colorado | 81501 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Atlanta | Georgia | 30322 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Indianapolis | Indiana | 46202 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cedar Rapids | Iowa | 52402 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Iowa City | Iowa | 52242 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ashland | Kentucky | 41101 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Boston | Massachusetts | 02115 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Omaha | Nebraska | 68114 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Albuquerque | New Mexico | 87109 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Salt Lake City | Utah | 84106 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Campinas | 13083970 | Brazil |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Calgary | Alberta | T2N 4N2 | Canada |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | London | W1T 4TJ | United Kingdom |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Manchester | M20 4BX | United Kingdom |
| FG001 | 300 mg Tabalumab+Dexamethasone+Bortezomib | Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles. |
| FG002 | Placebo Comparator: Placebo + Dexamethasone + Bortezomib | Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 100 mg Tabalumab+Dexamethasone+Bortezomib | Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 milligram per square meter (mg/m^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles. |
| BG001 | 300 mg Tabalumab+Dexamethasone+Bortezomib | Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles. |
| BG002 | Placebo Comparator: Placebo + Dexamethasone + Bortezomib | Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| 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 | Progression Free Survival (PFS) | PFS is defined as the time from date of first dose to the first observation of disease progression or death due to any cause. If a participant does not have a complete baseline disease assessment, then the PFS time is censored at the enrollment date, regardless of whether or not objectively determined disease progression (Increase of > 25% from lowest response in serum M component, urine M component, bone marrow plasma cell percentage, development of bone lesions) or death has been observed for the participant. If a participant is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time is censored at the last complete objective progression-free disease assessment date. | All randomized participants. | Posted | Median | 95% Confidence Interval | months | Baseline up to Objective Disease Progression or Death From Any Cause (assessed up to 9 months) |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is the duration from enrollment to death from any cause. For participants who were alive, overall survival was censored at the last contact. | All randomized participants. | Posted | Median | 95% Confidence Interval | months | Baseline to Death From Any Cause (assessed up to 19 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to First Skeletal-Related Event (SRE) | Time to first SRE is defined as time from randomization to any one of the following related to multiple myeloma: New Pathological Fracture, Spinal Cord Compression, Surgery to the Bone, Radiation to the Bone collected until participant death, study closure or lost to follow up. Participants not known to have had an SRE at the time of the analysis were censored at the date of their last complete documented assessment for SRE. | All randomized participants. | Posted | Median | 95% Confidence Interval | months | Baseline to Date of First Skeletal Related Event (assessed up to 19 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With >30% Reduction in Brief Pain Inventory (BPI) - Worst Pain Score | BPI is assessed by 7 questions rated "0" for "no pain" and higher numbers indicated more pain. | All randomized participants. | Posted | Count of Participants | Participants | No | Baseline through End of Treatment (19 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) | Time to progression is defined as the time from the date of randomization to the date of first observed objective progression or death due to study disease. Time to progression will be censored as for PFS for those participants not known to have progressed or that died from other causes. | All randomized participants, with 79 participants censored. | Posted | Median | 95% Confidence Interval | months | Baseline to Objective Disease Progression or Death (assessed up to 9 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) | DOR is measured by the International Myeloma Working Group Uniform Response Criteria: from the date of first evidence of a confirmed response to the date of objective progression or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, the DOR time will be censored at the last complete objective progression-free disease assessment date. Progressive disease is an increase of 25% from baseline in Serum M, Urine M, bone marrow plasma cell increase of 10 %, development of new bone lesions, development of new soft tissue plasmacytomas or bone lesions, hypercalcemia >11.5 milligrams per deciliter, decrease in hemoglobin of 2 grams per deciliter, rise in serum creatinine by 2 mg/deciliter. | All randomized participants who received at least 1 dose of study drug and had a response. | Posted | Median | 95% Confidence Interval | months | Time from Response to Objective Disease Progression (assessed up to 38 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Next Treatment (TNT) | TNT is defined as the time from the date of randomization to the date of initiation of the first poststudy treatment course of anticancer therapy or death from any cause. Time to next treatment will be censored at the date of the last visit for participant who did not initiate additional anticancer therapy. | All randomized participants. | Posted | Median | 95% Confidence Interval | months | Baseline to Initiation of New Cancer Treatment or Death From Any Cause (18 Months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab | Maximum Concentration (Cmax) of Tabalumab. | All randomized participants who received at least 1 dose of study drug and evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter | Cycle (C)1 Day (D)1: Predose, 3O minutes, 2 hours Postdose; C1 D4, 8, 11: Predose, (D11 only, 30 minutes Postdose); C2 and C6-C10 D1: Predose and immediately Postdose; C2 D 4, 8, 11: Anytime |
| |||||||||||||||||||||||||||||||||
| Secondary | PK: Time to Maximum Plasma Concentration (Tmax) of Tabalumab | All randomized participants who received at least 1 dose of study drug with evaluable PK values. | Posted | Mean | 95% Confidence Interval | hours | C1 D1: Predose, 3O minutes, 2 hours Postdose; C1 D4, 8, 11: Predose, (D11 only, 30 minutes Postdose); C2 and C6-C10 D1: Predose and immediately Postdose; C2 D 4, 8, 11: Anytime |
|
| |||||||||||||||||||||||||||||||||
| Secondary | PK: Area Under the Curve Over the Dosing Interval (AUC-T) for Tabalumab | All randomized participants who received at least 1 dose of study drug and had evaluable PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms times hour per milliliter | C1 D1: Predose, 3O minutes, 2 hours Postdose; C1 D4, 8, 11: Predose, (D11 only, 30 minutes Postdose); C2 and C6-C10 D1: Predose and immediately Postdose; C2 D 4, 8, 11: Anytime |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Developing Anti-tabalumab Antibodies | Zero participants analyzed, no data collected due to compound termination. | Posted | No | Baseline through Cycle 8 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Participants With Best Overall Response (BOR) in Each Category | Stringent Complete Response-Complete Response and normal free light chain ration and no clonal cells in bone marrow Complete Response- no monoclonal protein (mp) in blood, no serum or urine mp, less than 5% plasma cells in bone marrow Very Good Partial Response-more than 90% decrease in mp and urine protein Partial Response- over 50% decrease in serum mp Stable Disease- less than 25 percent decrease of monoclonal protein Progressive Disease- 25% increase compared to lowest value of serum mp, urine mp, no measurable mp | All randomized participants. | Posted | Count of Participants | Participants | No | Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (28 Months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Given Best Objective Myeloma Response (Quality of Response [QoR]) | Response categories in order of decreasing quality are: Stringent Complete Response(sCR),Complete Response(CR), Very Good Partial Response(VGPR),Partial Response(PR),Minimal Response(MR),Stable Disease(SD), or Progressive Disease(PD), according to the International Uniform Response Criteria for Multiple Myeloma.SCR:normal free light chain ration and no clonal cells in bone marrow;CR-no monoclonal protein(mp) in blood, no serum/urine,<5% plasma cells in bone marrow; VGPR-more than 90% decrease in mp and urine protein; PR->50% decrease in serum MP;SD-<25% decrease in mp; PD-25% increase compared to lowest value of serum mp, urine mp and no measurable mp. | All randomized participants. | Posted | Number | participants | Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (up to 28 Months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | Overall Response Rate (ORR) is the percentage of participants that had a response. | All randomized participants who had a partial response or greater. | Posted | Number | percentage of participants | Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (28 Months) |
|
Not provided
All randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 100 mg Tabalumab+Dexamethasone+Bortezomib | Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 milligram per square meter (mg/m^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles. | 33 | 73 | 71 | 73 | ||
| EG001 | 300 mg Tabalumab+Dexamethasone+Bortezomib | Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles. | 35 | 74 | 70 | 74 | ||
| EG002 | Placebo Comparator: Placebo + Dexamethasone + Bortezomib | Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles. | 26 | 72 | 69 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Ventricular dysfunction | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Left ventricle outflow tract obstruction | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Infectious colitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Traumatic haemorrhage | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Renal function test abnormal | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Plasma cell leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Autonomic neuropathy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000069286 | Bortezomib |
| C575974 | tabalumab |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United Kingdom |
|
| Spain |
|
| Greece |
|
| Canada |
|
| South Korea |
|
| Netherlands |
|
| Turkey |
|
| Taiwan |
|
| Brazil |
|
| Poland |
|
| Italy |
|
| Mexico |
|
| France |
|
| Germany |
|
|
|
| OG002 | Placebo Comparator: Placebo + Dexamethasone + Bortezomib | Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles. |
|
|
|
|
Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles. |
|
|
Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles. |
| OG002 | Placebo Comparator: Placebo + Dexamethasone + Bortezomib | Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles. |
|
|
Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles. |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
|
| OG002 | Placebo Comparator: Placebo + Dexamethasone + Bortezomib | Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles. |
|
|
| OG002 | Placebo Comparator: Placebo + Dexamethasone + Bortezombib | Placebo administered once IV on Day 1 every 21 days for 8 cycles.Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles. |
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