Status:
COMPLETED
Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
AbbVie
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/ Dexamethasone will prolong the time before myeloma worsens \[progression free survival (PFS)\].
Eligibility Criteria
Inclusion
- For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
- Documented progression from most recent line of therapy
- Measurable disease
- 1 to 3 prior lines of therapy
- Subjects may be proteasome inhibitor naive or have received prior proteasome inhibitor therapy provided all the following criteria are met:
- The subject did not discontinue any proteasome inhibitor due to intolerance or grade ≥ 3 toxicity
- The subject is not refractory to any proteasome inhibitor, defined as progression during treatment or within 60 days after the last dose
- The subject previously achieved a partial response (PR) or better to previous proteasome inhibitor (PI)
Exclusion
- Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, or Waldenstrom's macroglobulinemia
- Active plasma cell leukemia
- Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C
Key Trial Info
Start Date :
November 30 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2017
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT01478048
Start Date
November 30 2011
End Date
April 21 2017
Last Update
May 21 2018
Active Locations (77)
Enter a location and click search to find clinical trials sorted by distance.
1
Compassionate Cancer Res Grp
Corona, California, United States, 92879
2
Local Institution
Corona, California, United States, 92879
3
Local Institution
Long Beach, California, United States, 90806
4
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033