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

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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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)

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

Arm B: Lenalidomide + Dexamethasone

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


Participant Flow:   Overall Study
    Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)   Arm B: Lenalidomide + Dexamethasone
STARTED   40   42 
COMPLETED [1]   31 [1]   25 [1] 
NOT COMPLETED   9   17 
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



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All treated particpants

Reporting Groups
  Description
Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)

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

Arm B: Lenalidomide + Dexamethasone

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 Total of all reporting groups

Baseline Measures
   Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)   Arm B: Lenalidomide + Dexamethasone   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   42   82 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 72.6  (4.91)   74.0  (6.32)   73.3  (5.69) 
[1] All treated participants
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
     
Female      23  57.5%      20  47.6%      43  52.4% 
Male      17  42.5%      22  52.4%      39  47.6% 
[1] All treated participants
Ethnicity (NIH/OMB) [1] 
[Units: Participants]
Count of 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] All treated participants
Race (NIH/OMB) [1] 
[Units: Participants]
Count of 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] All treated participants


  Outcome Measures

1.  Primary:   Objective Response Rate (ORR) of Participants Treated With Elotuzumab + Lenalidomide/Dexamethasone (E-Ld)   [ Time Frame: From first dose until documented response (assessed up to February 2017, approximately 24 months) ]

2.  Secondary:   Objective Response Rate (ORR) in All Treated Participants   [ Time Frame: From first dose until documented response (assessed up to February 2017, approximately 24 months) ]

3.  Secondary:   Progression Free Survival (PFS) in Lenalidomide/Dexamethasone + Elotuzumab and Lenalidomide/Dexamethasone Therapy   [ 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) ]

4.  Secondary:   PFS Rate at 1 Year   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
phone: Please Email:
e-mail: Clinical.Trials@bms.com



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