Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan

• Status: Active, not recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy of Lenalidomide/Dexamethasone + Elotuzumab in the subjects with newly diagnosed, previously untreated Multiple Myeloma (MM) in Japan.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: AbbVie
• 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:

• Newly diagnosed with symptomatic Multiple Myeloma (MM)

• Have not received any prior systemic anti-myeloma therapy

• Have measurable disease

• 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 CA204-116 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old

Exclusion Criteria:

• Non-secretory 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