Spots Global Cancer Trial Database for Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With High-Risk Multiple Myeloma

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Trial Identification

Brief Title: Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With High-Risk Multiple Myeloma

Official Title: Maintenance Therapy With Carfilzomib, Pomalidomide and Dexamethasone (CPd) in High-Risk Myeloma Patients: A Phase 2 Study With a Safety Run-In

Study ID: NCT03756896

Conditions

Plasma Cell Myeloma

Interventions

Carfilzomib

Dexamethasone

Pomalidomide

Study Description

Brief Summary: This phase II trial studies how well carfilzomib, pomalidomide, and dexamethasone work in treating patients with high-risk multiple myeloma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pomalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carfilzomib, pomalidomide, and dexamethasone may work better in treating patients with multiple myeloma.

Detailed 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 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.