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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Dexamethasone; Drug: Elotuzumab; Drug: Lenalidomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02159365

CA204-112

Details and patient eligibility

About

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

Enrollment: 84 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:

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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84 participants in 1 patient group

Elotuzumab + Lenalidomide/Dexamethasone

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone

Drug: Lenalidomide

Drug: Elotuzumab