Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01441973
First received: September 27, 2011
Last updated: May 16, 2016
Last verified: December 2015
Results First Received: December 22, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Smoldering Multiple Myeloma
Intervention: Biological: Elotuzumab (BMS-901608; HuLuc63)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study enrolled a total of 41 participants, and 31 received treatment. The 10 participants enrolled who did not receive treatment failed to meet the inclusion criteria.

Reporting Groups
  Description
Elotuzumab, 20 mg/kg Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
Elotuzumab, 10 mg/kg Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.

Participant Flow:   Overall Study
    Elotuzumab, 20 mg/kg     Elotuzumab, 10 mg/kg  
STARTED     15     16  
COMPLETED     7 [1]   11 [1]
NOT COMPLETED     8     5  
Disease progression                 4                 2  
Adverse event unrelated to study drug                 3                 0  
Patient request to discontinue treatment                 1                 1  
Poor compliance/noncompliance                 0                 1  
Nonrelated cardiac amyloidosis                 0                 1  
[1] Still receiving treatment



  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 1 dose of study medication

Reporting Groups
  Description
Elotuzumab, 20 mg/kg Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
Elotuzumab, 10 mg/kg Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
Total Total of all reporting groups

Baseline Measures
    Elotuzumab, 20 mg/kg     Elotuzumab, 10 mg/kg     Total  
Number of Participants  
[units: participants]
  15     16     31  
Age  
[units: Years]
Mean (Standard Deviation)
  59.0  (9.75)     59.3  (9.37)     59.2  (9.40)  
Age, Customized  
[units: Participants]
     
Younger than 65 years     10     13     23  
65 years and older to younger than 75 years     5     2     7  
75 years and older     0     1     1  
Gender  
[units: Participants]
     
Female     5     9     14  
Male     10     7     17  
Ethnicity (NIH/OMB)  
[units: Participants]
     
Hispanic or Latino     0     1     1  
Not Hispanic or Latino     15     15     30  
Unknown or Not Reported     0     0     0  
Race/Ethnicity, Customized  
[units: Participants]
     
White     14     15     29  
Black or African American     1     1     2  
Serum monoclonal (M) protein  
[units: g/L]
Mean (Standard Deviation)
  29.5  (15.19)     21.9  (11.46)     25.6  (13.72)  
Urine M protein  
[units: g/day]
Mean (Standard Deviation)
  0.208  (0.6199)     0.094  (0.2131)     0.149  (0.4532)  
Time from diagnosis to enrollment  
[units: Months]
Mean (Standard Deviation)
  31.75  (37.572)     36.81  (35.103)     34.37  (35.798)  



  Outcome Measures
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1.  Primary:   Linear Regression of Maximal Percent Reduction in Serum Monoclonal (M) Protein on Baseline Percent CD56^Dim Cells in Bone Marrow   [ Time Frame: From day of last patient, first dose to 6 months ]

2.  Secondary:   Objective Response Rate (ORR)   [ Time Frame: From day of last patient, first dose to 6 months ]

3.  Secondary:   Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions   [ Time Frame: From day of last patient, first dose to 6 months ]

4.  Secondary:   Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality   [ Time Frame: From day of last patient, first dose to 6 months ]

5.  Secondary:   Number of Participants With a Dose- or Concentration-related Effect on QTcF Interval, PR Interval, QRS Interval, and Heart Rate   [ Time Frame: From day of last patient, first dose to 6 months ]


  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
No text entered.


  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: NCT01441973     History of Changes
Other Study ID Numbers: CA204-011
Study First Received: September 27, 2011
Results First Received: December 22, 2015
Last Updated: May 16, 2016
Health Authority: United States: Food and Drug Administration