Overview

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