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.

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Nivolumab; Drug: Pomalidomide; Drug: Elotuzumab; Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02612779

CA204-142

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd)

Experimental group

Description:

patients will receive treatment with elotuzumab in combination with pomalidomide and low-dose dexamethasone. Patients are eligible to receive Nivolumab at progression.

Treatment:

Drug: Dexamethasone

Drug: Elotuzumab

Drug: Pomalidomide

Drug: Nivolumab

Elotuzumab + Nivolumab (EN)

Experimental group

Description:

Patients will receive treatment with a combination of elotuzumab and nivolumab

Treatment:

Drug: Elotuzumab

Drug: Nivolumab