Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With High-Risk Multiple Myeloma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- 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 OBJECTIVE: I. To determine the ? complete response (CR) rates with carfilzomib, pomalidomide and dexamethasone (CPd) maintenance. SECONDARY OBJECTIVES: I. To determine the improved progression free survival (PFS) with CPd maintenance among high-risk patients. II. To determine the best respon...
PRIMARY OBJECTIVE: I. To determine the ? complete response (CR) rates with carfilzomib, pomalidomide and dexamethasone (CPd) maintenance. SECONDARY OBJECTIVES: I. To determine the improved progression free survival (PFS) with CPd maintenance among high-risk patients. II. To determine the best response rates (very good partial response rate [VGPR], stringent complete response [sCR] rate) with CPd maintenance. II. To evaluate the safety of the CPd combination as maintenance regimen. III. To characterize safety in subjects who receive CPd maintenance. IV. To evaluate the duration of response (DOR). V. To evaluate the overall survival (OS) in high-risk patients. VI. To evaluate the minimal residual disease (MRD) detection with CPd maintenance. OUTLINE: Patients receive carfilzomib intravenously (IV) over 30 minutes on days 1, 8, and 15, pomalidomide orally (PO) daily on days 1-21, and dexamethasone PO daily on days 1, 8, and 15. Cycles 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.
Tracking Information
- NCT #
- NCT03756896
- Collaborators
- Amgen
- Investigators
- Principal Investigator: Ajay Nooka, MD, MPH Emory University