Phase 2 Study of Lenalidomide/dexamethasone with or without Elotuzumab for newly diagnosed MM patients in Japan.

Phase 2

Completed

• Conditions: Multiple Myeloma

• Registration Number: JPRN-jRCT2080222753
• Lead Sponsor: Bristol-Myers Squibb K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Newly diagnosed with symptomatic Multiple Myeloma.
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 and above) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204-116 for a subject less than 65 years old. There must be a comorbidity that prevents SCT for a subject less than 65 years old.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified