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

Overview

Elotuzumab 10 mg/kg solution intravenously weekly in cycle 1 and 2, then every other week, Lenalidomide 25 mg tablet by mouth Days 1-21 of each cycle / Dexamethasone 40 mg tablet by mouth / solution intravenously weekly until progression or discontinuation of Elotuzumab
SparkCures ID 686
Trial Phase Phase 2
Enrollment 76 Patients
Treatments
Trial Sponsors
  • Bristol-Myers Squibb
NCT Identifier

NCT02159365

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

View Centers