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A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in Subjects With Relapsed/Refractory Multiple Myeloma

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma

Thank you

Trial Information

A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in Subjects With Relapsed/Refractory Multiple Myeloma

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) - Time from randomization to date of first tumor progression or death due to any cause

Outcome Time Frame:

Every 21 +/-7 days (Cycles 1-8) relative to the first dose of study medication

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

January 2012

Completion Date:

April 2015

Related Keywords:

  • Multiple Myeloma
  • Relapsed/Refractory Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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Local Institution Iowa City, Iowa  
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Local Institution Honolulu, Hawaii  
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