Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients

A Phase 2 Single Arm Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients

To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible and safe.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status ≤2

• Documented evidence of active multiple myeloma:

  • Newly diagnosed, not candidate for transplant
  • Relapsed/refractory who have received up to 3 prior lines of therapy

• Prior Lenalidomide exposure is permitted only if the following criteria are fulfilled:

  • Not refractory to prior Lenalidomide which is defined as no progression while receiving Lenalidomide or within 60 days of last dose of Lenalidomide
  • Subject did not discontinue Lenalidomide due to a Grade ≥3 related adverse event (AE)

Exclusion Criteria:

• Target Disease Exceptions

  • Plasma cell leukemia
  • Monoclonal gammopathy of undetermined significance (MGUS)
  • Smoldering Myeloma

• Primary amyloidosis

• Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome