Japanese Study of BMS-901608 (Elotuzumab) in Combination With Lenalidomide and Low Dose Dexamethasone

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01241292
First received: November 4, 2010
Last updated: January 22, 2016
Last verified: January 2016
Results First Received: December 16, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Biological: BMS-901608 (Elotuzumab) 10 mg
Biological: BMS-901608 (Elotuzumab) 20 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study is on-going. Data presented from primary endpoint cut-off date, February 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Seven participants were enrolled and 6 entered the treatment period. Reason for 1 participant not entering treatment period: participant no longer met study criteria.

Reporting Groups
  Description
Elotuzumab 10 mg/kg Elotuzumab 10 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
Elotuzumab 20 mg/kg Elotuzumab 20 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).

Participant Flow:   Overall Study
    Elotuzumab 10 mg/kg     Elotuzumab 20 mg/kg  
STARTED     3     3  
COMPLETED     2 [1]   1 [1]
NOT COMPLETED     1     2  
Disease Progression                 1                 0  
Withdrawal by Subject                 0                 2  
[1] completed=treatment on-going



  Baseline Characteristics
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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 participants who received at least one dose of study drug were summarized.

Reporting Groups
  Description
Elotuzumab 10 mg/kg

Elotuzumab was intravenously (IV) injected at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.

Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.

On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).

Elotuzumab 20 mg/kg

Elotuzumab was intravenously (IV) injected at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.

Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.

On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion).

Total Total of all reporting groups

Baseline Measures
    Elotuzumab 10 mg/kg     Elotuzumab 20 mg/kg     Total  
Number of Participants  
[units: participants]
  3     3     6  
Age  
[units: years]
Median (Full Range)
  61.0  
  (52 to 66)  
  66.0  
  (60 to 75)  
  63.5  
  (52 to 75)  
Age, Customized  
[units: participants]
     
Less than (<) 65     2     1     3  
65 to < 75     1     1     2  
Greater than, equal to 75     0     1     1  
Gender  
[units: participants]
     
Female     1     2     3  
Male     2     1     3  
Region of Enrollment  
[units: participants]
     
Japan     3     3     6  



  Outcome Measures
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1.  Primary:   Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Deaths   [ Time Frame: First dose (Day 1) to last dose plus 60 days, up to 3 years ]

2.  Primary:   Number of Participants With Clinically Relevant Vital Sign Findings   [ Time Frame: First dose (Day 1) to last dose plus 60 days, up to 3 years ]

3.  Primary:   Number of Participants With Worst Toxicity Grade Hematology Laboratory Tests   [ Time Frame: First dose (Day 1) to last dose plus 60 days, up to 3 years ]

4.  Primary:   Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests   [ Time Frame: First dose (Day 1) to last dose plus 60 days, up to 3 years ]

5.  Primary:   Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests   [ Time Frame: First dose (Day 1) to last dose plus 60 days, up to 3 years ]

6.  Secondary:   Number of Participants With Best Overall Response - Treated Participants   [ Time Frame: Cycle 2 (Study Day 29) to last dose, up to 3 years ]

7.  Secondary:   Geometric Mean Maximum Observed Serum Elotuzumab Concentration (Cmax) During Cycles 1, 2, and 3   [ Time Frame: Days 1, 8, 15 and 22 of cycle 1, Days 1 and 22 of cycle 2, Days 1 and 15 of cycle 3 ]

8.  Secondary:   Geometric Mean Minimum Observed Serum Elotuzumab Concentration (Cmin) During Cycles 1, 2, and 3   [ Time Frame: Days 8, 15 and 22 of cycle 1, Days 1 and 22 of cycle 2, Days 1 and 15 of cycle 3 ]

9.  Secondary:   Number of Participants Positive for Anti-Elotuzumab Anti-drug Antibodies - Treated Participants   [ Time Frame: First dose (Day 1) to last dose plus 60 days, up to 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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
e-mail: Clinical.Trials@bms.com



Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01241292     History of Changes
Other Study ID Numbers: CA204-005
Study First Received: November 4, 2010
Results First Received: December 16, 2015
Last Updated: January 22, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency