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Trial record 11 of 50 for:    Elotuzumab

Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02272803
Recruitment Status : Active, not recruiting
First Posted : October 23, 2014
Results First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Lenalidomide
Drug: Dexamethasone
Biological: Elotuzumab (BMS-901608)
Enrollment 90
Recruitment Details  
Pre-assignment Details 90 participants were enrolled; 82 were randomized and treated. Participants were enrolled but not treated because they no longer met study criteria (n=7) or they withdrew consent (n=1).
Arm/Group Title Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) Arm B: Lenalidomide + Dexamethasone
Hide Arm/Group Description

Drug: Lenalidomide

Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Drug: Dexamethasone

Tablets, Oral 28 mg and Intravenous (IV) 8 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Biological: Elotuzumab (BMS-901608)

Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Drug: Lenalidomide

Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Drug: Dexamethasone

Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Period Title: Overall Study
Started 40 42
Completed [1] 31 [1] 25 [1]
Not Completed 9 17
Reason Not Completed
Disease progression             4             2
Adverse Event unrelated to study drug             1             4
Study drug toxicity             1             4
Subj request to discontinue study trt             1             4
Maximum clinical benefit             1             1
Subject moved to care facility             0             1
Poor/non-compliance             0             1
Withdrawal by Subject             1             0
[1]
Completed = Still receiving treatment
Arm/Group Title Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) Arm B: Lenalidomide + Dexamethasone Total
Hide Arm/Group Description

Drug: Lenalidomide

Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Drug: Dexamethasone

Tablets, Oral 28 mg and Intravenous (IV) 8 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Biological: Elotuzumab (BMS-901608)

Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Drug: Lenalidomide

Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Drug: Dexamethasone

Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Total of all reporting groups
Overall Number of Baseline Participants 40 42 82
Hide Baseline Analysis Population Description
All treated particpants
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 42 participants 82 participants
72.6  (4.91) 74.0  (6.32) 73.3  (5.69)
[1]
Measure Analysis Population Description: All treated participants
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 42 participants 82 participants
Female
23
  57.5%
20
  47.6%
43
  52.4%
Male
17
  42.5%
22
  52.4%
39
  47.6%
[1]
Measure Analysis Population Description: All treated participants
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 42 participants 82 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
40
 100.0%
42
 100.0%
82
 100.0%
[1]
Measure Analysis Population Description: All treated participants
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 42 participants 82 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
40
 100.0%
42
 100.0%
82
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: All treated participants
1.Primary Outcome
Title Objective Response Rate (ORR) of Participants Treated With Elotuzumab + Lenalidomide/Dexamethasone (E-Ld)
Hide Description

ORR is the proportion of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or PR as determined by investigator using the International Myeloma Working Group (IMWG) response criteria.

SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.

Time Frame From first dose until documented response (assessed up to February 2017, approximately 24 months)
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Hide Analysis Population Description
Participants treated with E-Ld
Arm/Group Title Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)
Hide Arm/Group Description:

Drug: Lenalidomide

Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Drug: Dexamethasone

Tablets, Oral 28 mg and Intravenous (IV) 8 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Biological: Elotuzumab (BMS-901608)

Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Overall Number of Participants Analyzed 40
Measure Type: Number
Number (70% Confidence Interval)
Unit of Measure: Percentage of participants
87.5
(79.7 to 92.9)
2.Secondary Outcome
Title Objective Response Rate (ORR) in All Treated Participants
Hide Description

ORR is the proportion of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or PR as determined by investigator using the International Myeloma Working Group (IMWG) response criteria.

SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.

Time Frame From first dose until documented response (assessed up to February 2017, approximately 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) Arm B: Lenalidomide + Dexamethasone
Hide Arm/Group Description:

Drug: Lenalidomide

Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Drug: Dexamethasone

Tablets, Oral 28 mg and Intravenous (IV) 8 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Biological: Elotuzumab (BMS-901608)

Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Drug: Lenalidomide

Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Drug: Dexamethasone

Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Overall Number of Participants Analyzed 40 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
87.5
(73.2 to 95.8)
73.8
(58.0 to 86.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608), Arm B: Lenalidomide + Dexamethasone
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Objective Response Rate
Estimated Value 13.0
Confidence Interval (2-Sided) 95%
-3.5 to 29.6
Estimation Comments Difference of E-Ld minus Ld. Computed using the method of DerSimonian and Laird (weighted average over the strata as recorded in randomization file).
3.Secondary Outcome
Title Progression Free Survival (PFS) in Lenalidomide/Dexamethasone + Elotuzumab and Lenalidomide/Dexamethasone Therapy
Hide Description PFS was defined as the time from randomization to the date of the first documented tumor progression, as determined by the investigator using the IMWG response criteria, or to death due to any cause, provided death does not occur more than 10 weeks (2 or more assessment visits) after the last tumor assessment. Clinical deterioration will not be considered progression.
Time Frame From randomization to the date of first documented tumor progression or death due to any cause (assessed up to February 2017, approximately 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) Arm B: Lenalidomide + Dexamethasone
Hide Arm/Group Description:

Drug: Lenalidomide

Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Drug: Dexamethasone

Tablets, Oral 28 mg and Intravenous (IV) 8 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Biological: Elotuzumab (BMS-901608)

Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Drug: Lenalidomide

Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Drug: Dexamethasone

Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Overall Number of Participants Analyzed 40 42
Median (95% Confidence Interval)
Unit of Measure: months
22.21 [1] 
(22.21 to NA)
NA [1] 
(16.20 to NA)
[1]
PFS was not estimable due to an insufficient number of participants with events
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608), Arm B: Lenalidomide + Dexamethasone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.25 to 2.71
Estimation Comments Hazard Ratio of E-Ld to Ld. Stratified by stage of disease (International Staging System 1 - 2 vs 3)
4.Secondary Outcome
Title PFS Rate at 1 Year
Hide Description The number of participants with PFS at 1 year post-randomization was divided by the total number randomized in that arm and expressed as a percentage. PFS was defined as the time from randomization to the date of the first documented tumor progression, as determined by the investigator using the IMWG response criteria, or to death due to any cause, provided death does not occur more than 10 weeks (2 or more assessment visits) after the last tumor assessment. Clinical deterioration will not be considered progression.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) Arm B: Lenalidomide + Dexamethasone
Hide Arm/Group Description:

Drug: Lenalidomide

Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Drug: Dexamethasone

Tablets, Oral 28 mg and Intravenous (IV) 8 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Biological: Elotuzumab (BMS-901608)

Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Drug: Lenalidomide

Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Drug: Dexamethasone

Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Overall Number of Participants Analyzed 40 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
93
(79 to 98)
91
(73 to 97)
Time Frame From first dose to date of last dose plus 60 days (assessed up to February 2017, approximately 24 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide + Dexamethasone
Hide Arm/Group Description

Drug: Lenalidomide

Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Drug: Dexamethasone

Tablets, Oral 28 mg and Intravenous (IV) 8 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Biological: Elotuzumab (BMS-901608)

Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Drug: Lenalidomide

Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

Drug: Dexamethasone

Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug

All-Cause Mortality
Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide + Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   1/40 (2.50%)   3/42 (7.14%) 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide + Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   11/40 (27.50%)   16/42 (38.10%) 
Blood and lymphatic system disorders     
Disseminated intravascular coagulation  1  0/40 (0.00%)  1/42 (2.38%) 
Cardiac disorders     
Cardiac failure  1  0/40 (0.00%)  2/42 (4.76%) 
Cardiac failure acute  1  0/40 (0.00%)  1/42 (2.38%) 
Cardiac failure congestive  1  1/40 (2.50%)  0/42 (0.00%) 
Eosinophilic myocarditis  1  0/40 (0.00%)  1/42 (2.38%) 
Eye disorders     
Cataract  1  1/40 (2.50%)  1/42 (2.38%) 
Gastrointestinal disorders     
Intestinal perforation  1  0/40 (0.00%)  1/42 (2.38%) 
Ischaemic enteritis  1  0/40 (0.00%)  1/42 (2.38%) 
Lower gastrointestinal haemorrhage  1  0/40 (0.00%)  1/42 (2.38%) 
Stomatitis  1  1/40 (2.50%)  0/42 (0.00%) 
General disorders     
Chills  1  1/40 (2.50%)  0/42 (0.00%) 
Hepatobiliary disorders     
Hepatic function abnormal  1  0/40 (0.00%)  1/42 (2.38%) 
Infections and infestations     
Influenza  1  1/40 (2.50%)  0/42 (0.00%) 
Lung infection  1  0/40 (0.00%)  1/42 (2.38%) 
Peritonitis  1  0/40 (0.00%)  1/42 (2.38%) 
Pneumonia  1  1/40 (2.50%)  3/42 (7.14%) 
Sepsis  1  1/40 (2.50%)  1/42 (2.38%) 
Injury, poisoning and procedural complications     
Spinal compression fracture  1  2/40 (5.00%)  1/42 (2.38%) 
Investigations     
C-reactive protein increased  1  1/40 (2.50%)  0/42 (0.00%) 
Neutrophil count decreased  1  1/40 (2.50%)  0/42 (0.00%) 
Platelet count decreased  1  1/40 (2.50%)  0/42 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  0/40 (0.00%)  1/42 (2.38%) 
Hyperglycaemia  1  0/40 (0.00%)  1/42 (2.38%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/40 (2.50%)  2/42 (4.76%) 
Muscle spasms  1  0/40 (0.00%)  1/42 (2.38%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastrointestinal stromal tumour  1  0/40 (0.00%)  1/42 (2.38%) 
Lung neoplasm malignant  1  0/40 (0.00%)  1/42 (2.38%) 
Papillary thyroid cancer  1  0/40 (0.00%)  1/42 (2.38%) 
Rectal cancer  1  1/40 (2.50%)  0/42 (0.00%) 
Nervous system disorders     
Dizziness  1  0/40 (0.00%)  1/42 (2.38%) 
Syncope  1  0/40 (0.00%)  1/42 (2.38%) 
Psychiatric disorders     
Delirium  1  0/40 (0.00%)  1/42 (2.38%) 
Depression  1  1/40 (2.50%)  0/42 (0.00%) 
Renal and urinary disorders     
Urinary retention  1  0/40 (0.00%)  1/42 (2.38%) 
Respiratory, thoracic and mediastinal disorders     
Interstitial lung disease  1  1/40 (2.50%)  0/42 (0.00%) 
Pulmonary embolism  1  0/40 (0.00%)  1/42 (2.38%) 
Skin and subcutaneous tissue disorders     
Drug reaction with eosinophilia and systemic symptoms  1  0/40 (0.00%)  1/42 (2.38%) 
Vascular disorders     
Deep vein thrombosis  1  1/40 (2.50%)  0/42 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide + Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   40/40 (100.00%)   41/42 (97.62%) 
Blood and lymphatic system disorders     
Anaemia  1  2/40 (5.00%)  5/42 (11.90%) 
Leukopenia  1  8/40 (20.00%)  3/42 (7.14%) 
Lymphopenia  1  5/40 (12.50%)  4/42 (9.52%) 
Neutropenia  1  8/40 (20.00%)  6/42 (14.29%) 
Thrombocytopenia  1  2/40 (5.00%)  1/42 (2.38%) 
Cardiac disorders     
Atrial fibrillation  1  3/40 (7.50%)  1/42 (2.38%) 
Ear and labyrinth disorders     
Tinnitus  1  4/40 (10.00%)  0/42 (0.00%) 
Vertigo  1  3/40 (7.50%)  0/42 (0.00%) 
Eye disorders     
Cataract  1  6/40 (15.00%)  1/42 (2.38%) 
Eyelid oedema  1  2/40 (5.00%)  0/42 (0.00%) 
Glaucoma  1  2/40 (5.00%)  0/42 (0.00%) 
Gastrointestinal disorders     
Abdominal discomfort  1  2/40 (5.00%)  0/42 (0.00%) 
Abdominal pain upper  1  3/40 (7.50%)  0/42 (0.00%) 
Chronic gastritis  1  2/40 (5.00%)  1/42 (2.38%) 
Constipation  1  17/40 (42.50%)  13/42 (30.95%) 
Dental caries  1  3/40 (7.50%)  2/42 (4.76%) 
Diarrhoea  1  11/40 (27.50%)  9/42 (21.43%) 
Haemorrhoids  1  0/40 (0.00%)  3/42 (7.14%) 
Nausea  1  5/40 (12.50%)  4/42 (9.52%) 
Stomatitis  1  6/40 (15.00%)  0/42 (0.00%) 
Vomiting  1  6/40 (15.00%)  1/42 (2.38%) 
General disorders     
Chest pain  1  4/40 (10.00%)  3/42 (7.14%) 
Influenza like illness  1  2/40 (5.00%)  1/42 (2.38%) 
Malaise  1  9/40 (22.50%)  1/42 (2.38%) 
Oedema  1  4/40 (10.00%)  2/42 (4.76%) 
Oedema peripheral  1  8/40 (20.00%)  6/42 (14.29%) 
Pyrexia  1  14/40 (35.00%)  3/42 (7.14%) 
Hepatobiliary disorders     
Hepatic function abnormal  1  6/40 (15.00%)  1/42 (2.38%) 
Liver disorder  1  2/40 (5.00%)  0/42 (0.00%) 
Immune system disorders     
Seasonal allergy  1  2/40 (5.00%)  0/42 (0.00%) 
Infections and infestations     
Bronchitis  1  4/40 (10.00%)  2/42 (4.76%) 
Hepatitis b  1  2/40 (5.00%)  0/42 (0.00%) 
Influenza  1  2/40 (5.00%)  0/42 (0.00%) 
Lung infection  1  1/40 (2.50%)  3/42 (7.14%) 
Nasopharyngitis  1  10/40 (25.00%)  11/42 (26.19%) 
Oral herpes  1  0/40 (0.00%)  4/42 (9.52%) 
Periodontitis  1  2/40 (5.00%)  0/42 (0.00%) 
Pharyngitis  1  2/40 (5.00%)  1/42 (2.38%) 
Pneumonia  1  3/40 (7.50%)  1/42 (2.38%) 
Upper respiratory tract infection  1  7/40 (17.50%)  3/42 (7.14%) 
Urinary tract infection  1  5/40 (12.50%)  2/42 (4.76%) 
Injury, poisoning and procedural complications     
Contusion  1  5/40 (12.50%)  0/42 (0.00%) 
Spinal compression fracture  1  2/40 (5.00%)  1/42 (2.38%) 
Investigations     
Blood creatinine increased  1  2/40 (5.00%)  2/42 (4.76%) 
C-reactive protein increased  1  2/40 (5.00%)  1/42 (2.38%) 
Creatinine renal clearance decreased  1  6/40 (15.00%)  0/42 (0.00%) 
Lymphocyte count decreased  1  2/40 (5.00%)  2/42 (4.76%) 
Neutrophil count decreased  1  5/40 (12.50%)  4/42 (9.52%) 
Platelet count decreased  1  4/40 (10.00%)  0/42 (0.00%) 
Weight decreased  1  2/40 (5.00%)  2/42 (4.76%) 
White blood cell count decreased  1  3/40 (7.50%)  1/42 (2.38%) 
Metabolism and nutrition disorders     
Decreased appetite  1  6/40 (15.00%)  3/42 (7.14%) 
Dehydration  1  2/40 (5.00%)  1/42 (2.38%) 
Diabetes mellitus  1  2/40 (5.00%)  1/42 (2.38%) 
Hyperglycaemia  1  4/40 (10.00%)  3/42 (7.14%) 
Hyponatraemia  1  3/40 (7.50%)  0/42 (0.00%) 
Hypophosphataemia  1  0/40 (0.00%)  4/42 (9.52%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/40 (7.50%)  2/42 (4.76%) 
Back pain  1  7/40 (17.50%)  8/42 (19.05%) 
Muscle spasms  1  1/40 (2.50%)  6/42 (14.29%) 
Muscular weakness  1  1/40 (2.50%)  3/42 (7.14%) 
Pain in extremity  1  4/40 (10.00%)  3/42 (7.14%) 
Nervous system disorders     
Dizziness  1  3/40 (7.50%)  5/42 (11.90%) 
Dysgeusia  1  9/40 (22.50%)  8/42 (19.05%) 
Headache  1  3/40 (7.50%)  0/42 (0.00%) 
Hypoaesthesia  1  3/40 (7.50%)  1/42 (2.38%) 
Loss of consciousness  1  2/40 (5.00%)  0/42 (0.00%) 
Somnolence  1  2/40 (5.00%)  0/42 (0.00%) 
Psychiatric disorders     
Delirium  1  3/40 (7.50%)  1/42 (2.38%) 
Insomnia  1  7/40 (17.50%)  8/42 (19.05%) 
Renal and urinary disorders     
Chronic kidney disease  1  3/40 (7.50%)  1/42 (2.38%) 
Cystitis noninfective  1  2/40 (5.00%)  0/42 (0.00%) 
Haematuria  1  2/40 (5.00%)  0/42 (0.00%) 
Renal impairment  1  2/40 (5.00%)  2/42 (4.76%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/40 (5.00%)  1/42 (2.38%) 
Hiccups  1  2/40 (5.00%)  4/42 (9.52%) 
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  2/40 (5.00%)  2/42 (4.76%) 
Dry skin  1  3/40 (7.50%)  1/42 (2.38%) 
Pruritus  1  7/40 (17.50%)  5/42 (11.90%) 
Purpura  1  3/40 (7.50%)  1/42 (2.38%) 
Rash  1  11/40 (27.50%)  15/42 (35.71%) 
Rash maculo-papular  1  0/40 (0.00%)  3/42 (7.14%) 
Vascular disorders     
Hypertension  1  2/40 (5.00%)  1/42 (2.38%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Phone: Please Email:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02272803     History of Changes
Other Study ID Numbers: CA204-116
First Submitted: October 21, 2014
First Posted: October 23, 2014
Results First Submitted: January 26, 2018
Results First Posted: March 22, 2018
Last Update Posted: March 22, 2018