Belantamab Mafodotin, Pomalidomide and Dexamethasone for the Treatment of High-Risk Myeloma

Active:	Yes
Cancer Type:	Multiple Myeloma Plasma cell neoplasm	NCT ID:	NCT05208307
Trial Phases:	Phase II	Protocol IDs:	Winship5382-21 (primary) NCI-2021-08385 STUDY00003092
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/NCT05208307

Summary

This phase II trial studies the effect of belantamab mafodotin, pomalidomide, and dexamethasone in treating patents with high-risk myeloma. Belantamab mafodotin is a monoclonal antibody, called belantamab, linked to a chemotherapy drug, called mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules on the surface of cancer cells, known as BCMA receptors, and delivers mafodotin to kill them. Chemotherapy drugs, such as pomalidomide, 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. Anti-inflammatory drugs, such as dexamethasone lower the body’s immune response and are used with other drugs in the treatment of some types of cancer. Giving belantamab mafodotin, pomalidomide, and dexamethasone may kill more cancer cells.

Objectives

PRIMARY OBJECTIVE:
I. To evaluate the efficacy of the combination of belantamab mafodotin, pomalidomide and dexamethasone (BPd) by assessing the >= complete response (CR) rates with BPd maintenance in patients with high-risk myeloma by International Myeloma Working Group (IMWG) criteria.

SECONDARY OBJECTIVES:
I. To evaluate the safety and tolerability of the combination of BPd in patients with high-risk myeloma.
II. To determine the antitumor activity of BPd maintenance among high-risk myeloma patients.

TERTIARY/EXPLORATORY OBJECTIVE:
I. To evaluate the changes in microenvironment among patients receiving BPd maintenance.

OUTLINE:
Patients receive belantamab mafodotin intravenously (IV) over 30 minutes on day 1 of every other cycle, pomalidomide orally (PO) once daily (QD) on days 1-21, and dexamethasone PO QD on days 1, 8, 15, and 22. 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.

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