Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Trial end date: 2017-04-21
• Target enrollment: 0
• Participant gender: All

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)].

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: AbbVie
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Elotuzumab

Criteria

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email[email protected]. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

• 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:

1. The subject did not discontinue any proteasome inhibitor due to intolerance or grade ≥ 3 toxicity

2. The subject is not refractory to any proteasome inhibitor, defined as progression during treatment or within 60 days after the last dose

3. The subject previously achieved a partial response (PR) or better to previous proteasome inhibitor (PI)

Exclusion Criteria:

• 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