Dexamethasone, Elotuzumab, and Pomalidomide in Treating Patients With Refractory Multiple Myeloma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Refractory Plasma Cell Myeloma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To determine the overall response rate (ORR) of utilizing elotuzumab, pomalidomide and dexamethasone in patients with disease refractory to daratumumab. SECONDARY OBJECTIVES: I. To determine percentage of patients achieving complete response (CR) with the elotuzumab combinatio...
PRIMARY OBJECTIVES: I. To determine the overall response rate (ORR) of utilizing elotuzumab, pomalidomide and dexamethasone in patients with disease refractory to daratumumab. SECONDARY OBJECTIVES: I. To determine percentage of patients achieving complete response (CR) with the elotuzumab combination. II. To determine progression-free survival (PFS) for treatment with the elotuzumab combination. III. To determine safety profile for treatment with the elotuzumab combination. IV. To determine the overall survival (OS) for patients receiving treatment with the elotuzumab combination. OUTLINE: Patients receive dexamethasone intravenously (IV) on days 1, 8, 15, and 22 of courses 1-2 and IV on day 1 and orally (PO) on days 8, 15, and 22 of subsequent courses and elotuzumab IV on days 1, 8, 15, and 22 of courses 1-2 and day 1 of subsequent courses. Patients also receive pomalidomide PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months until progressive disease, then every 6 months thereafter.
Tracking Information
- NCT #
- NCT03713294
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Sikander Ailawadhi Mayo Clinic