PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy)

• Status: Terminated
• Trial end date: 2020-06-25
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to look at subjects who receive Lenalidomide, Dexamethasone, and Elotuzumab and determine if they will have lower surface CS1 expression on malignant plasma cells at the time of progression than those who receive Lenalidomide and Dexamethasone without Elotuzumab

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Abbott
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Elotuzumab; Lenalidomide; Thalidomide

Criteria

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

Inclusion Criteria:

Subjects who are newly diagnosed with symptomatic MM and who:

• Have not received any prior systemic anti-myeloma therapy

• 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 CA204-006 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