Recruitment

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