An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)

• Status: Active, not recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma compared to pomalidomide and low-dose dexamethasone by itself.

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborators: AbbVie; Celgene
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Elotuzumab; Pomalidomide; Thalidomide

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• ≥ 2 prior lines of therapy which must have included at least 2 consecutive cycles of lenalidomide and a proteosome inhibitor alone or in combination

• Documented refractory or relapsed and refractory multiple myeloma

• Refractory to proteosome inhibitor and lenalidomide, and to last treatment

• Relapsed and refractory patients must have achieved at least a partial response to previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed within 6 months, and were refractory to their last treatment

• Measurable disease at screening

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

• Active plasma cell leukemia

• Prior treatment with pomalidomide

• Unable to tolerate thromboembolic prophylaxis while on the study

• Prior autologous stem cell transplant within 12 weeks

• Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C