A Study of Elotuzumab in Combination With Pomalidomide and Low Dose Dexamethasone and Elotuzumab in Combination With Nivolumab in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Elotuzumab; Pomalidomide; Dexamethasone; Nivolumab
Intervention MeSH terms: Dexamethasone; Nivolumab; Pomalidomide; Elotuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study of elotuzumab in combination with pomalidomide and low dose dexamethasone (EPd Cohort)
      and elotuzumab in combination with nivolumab (EN Cohort) to assess the safety and efficacy of
      these combination therapies for treatment of relapsed or refractory MM patients.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          1. All subjects must have documented disease progression per IMWG criteria during or
             after their last anti-myeloma therapy.

          2. ECOG Performance Status less than or equal to 2

          3. Subject Re-enrollment: This study permits the re-enrollment of a subject that has
             discontinued the study as a pre-treatment failure (ie, has not been treated). If
             re-enrolled, the subject must be re-consented.

          4. EPd Cohort:

               -  must have received at least 1 but no greater than 2 prior lines of therapy (note:
                  induction and stem cell transplants with or without maintenance therapy is
                  considered 1 line of therapy)

               -  Subjects must have received prior treatment with a lenalidomide-containing
                  regimen for at least 2 consecutive cycles (full therapeutic dose) and must have
                  been deemed as relapsed, refractory, or intolerant. Refractory is defined as
                  progressing on-treatment or within 60 days of the last dose.

          5. EN Cohort:

               -  Subjects must have received at least 3 prior lines of therapy including a
                  proteasome inhibitor (PI) and an immunomodulatory (IMID) agent OR were
                  double-refractory to both an IMID and a PI. Refractory is defined as progressing
                  on-treatment or within 60 days of the last dose.

        Exclusion Criteria:

          1. Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of
             plasma cells dyscrasia

          2. Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering
             multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, or POEMS
             syndrome (plasma cell dyscrasia with poly neuropathy, organomegaly, endocrinopathy,
             monoclonal protein, and skin changes)

          3. Subjects with Central Nervous System involvement with multiple myeloma

        Other protocol defined inclusion/exclusion criteria could apply.