Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma (ELOQUENT - 2)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Multiple Myeloma; Lymphoma

Treatments: Drug: Dexamethasone (IV); Drug: Lenalidomide; Drug: Dexamethasone (Oral); Biological: Elotuzumab (BMS-901608; HuLuc63); Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01239797

2010-020347-12 (EudraCT Number)

CA204-004

Details and patient eligibility

About

The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).

Enrollment: 646 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:

• Documented progression from most recent line of therapy

• 1-3 prior lines of therapy

• Measurable disease

• Life expectancy ≥3 months

• Prior treatment with Lenalidomide permitted if:

  1. Best response achieved was ≥Partial Response (PR)
  2. Patient was not refractory
  3. Patient did not discontinue due to a Grade ≥3 related adverse event
  4. Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression

Exclusion Criteria:

• Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma
• Active plasma cell leukemia
• Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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646 participants in 2 patient groups

Lenalidomide + Dexamethasone

Active Comparator group

Treatment:

Drug: Dexamethasone

Drug: Lenalidomide

Lenalidomide + Dexamethasone +Elotuzumab

Experimental group

Treatment:

Biological: Elotuzumab (BMS-901608; HuLuc63)

Drug: Dexamethasone (Oral)

Drug: Lenalidomide

Drug: Dexamethasone (IV)