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

Active:	No
Cancer Type:	Multiple Myeloma Plasma cell neoplasm	NCT ID:	NCT03756896
Trial Phases:	Phase II	Protocol IDs:	Winship4101-17 (primary) NCI-2017-02052 IRB00097882
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT03756896

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.