Overview

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

Status:
Active, not recruiting
Trial end date:
2021-06-01
Target enrollment:
0
Participant gender:
All
Summary
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)
Phase:
Phase 3
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:

- 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