Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Elotuzumab; Bortezomib; Dexamethasone; Dexamethasone; Dexamethasone; Dexamethasone
Intervention description: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until subject meets criteria for discontinuation of study drug; Solution; IV; 1.3 mg/m2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until subject meets criteria for discontinuation of study drug; Tablets; Oral; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until subject meets criteria for discontinuation of study drug; Tablets; Oral; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until subject meets criteria for discontinuation of study drug; Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until subject meets criteria for discontinuation of study drug; Tablets; Oral; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until subject meets criteria for discontinuation of study drug
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Bortezomib; Elotuzumab; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsed/Refractory Multiple Myeloma

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:

        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.

        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