Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma (ELOQUENT - 1)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Multiple Myeloma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01335399

2010-022445-20 (EudraCT Number)

CA204-006

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: 748 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:

• Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:

  • have not received any prior systemic anti-myeloma therapy AND
  • have measurable disease AND
  • are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old

Exclusion Criteria:

• Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
• Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
• Monoclonal Gammopathy of Undetermined Significance (MGUS)
• 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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748 participants in 2 patient groups

Lenalidomide + Dexamethasone

Active Comparator group

Treatment:

Drug: Dexamethasone

Drug: Dexamethasone

Drug: Lenalidomide

Drug: Dexamethasone

Drug: Dexamethasone

Lenalidomide + Dexamethasone + Elotuzumab

Experimental group

Treatment:

Biological: Elotuzumab (BMS-901608; HuLuc63)

Drug: Dexamethasone

Drug: Dexamethasone

Drug: Lenalidomide

Biological: Elotuzumab (BMS-901608; HuLuc63)

Drug: Dexamethasone

Drug: Dexamethasone