NCT03756896

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Plasma Cell Myeloma

Interventions

Type	Name	Description
DRUG	Carfilzomib	Given IV
DRUG	Dexamethasone	Given PO
DRUG	Pomalidomide	Given PO

Timeline

• Start date: 2019-01-25
• Primary completion: 2025-06-24
• Completion: 2026-06-30
• First posted: 2018-11-28
• Last updated: 2025-04-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study