Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Trial end date: 2021-04-21
• 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:

• Documented progression from most recent line of therapy

• 1-3 prior lines of therapy

• Measurable disease

• Life expectancy ≥3 months

• Prior treatment with Lenalidomide permitted if:

1. Best response achieved was ≥Partial Response (PR)

2. Patient was not refractory

3. Patient did not discontinue due to a Grade ≥3 related adverse event

4. Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression

Exclusion Criteria:

• Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma

• Active plasma cell leukemia

• Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C