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HDAC Inhibitor AR-42 and Pomalidomide in Treating Patients With Relapsed Multiple Myeloma

Recurrent Plasma Cell Myeloma Clinical Trial

Official title:
A Phase 1b Trial of AR-42 With Pomalidomide in Relapsed Multiple Myeloma

Clinical Trial Summary

This pilot phase I trial studies the side effects and best dose of histone deacetylase (HDAC) inhibitor AR-42 (AR-42) when given together with pomalidomide in treating patients with multiple myeloma that has returned after a period of improvement. HDAC inhibitor AR-42 may work to stop cancer growth by blocking an enzyme needed for cell growth. Pomalidomide is a drug used in chemotherapy that works to stop the growth of cancer cells by causing them to die. Giving HDAC inhibitor AR-42 together with pomalidomide may cause patients to respond better to treatment.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose, safety and efficacy of AR-42 in combination with pomalidomide in relapsed multiple myeloma (MM) patients. SECONDARY OBJECTIVES: I. To determine time to progression (TTP). II. To determine overall survival (OS). OUTLINE: This is a dose-escalation study of HDAC inhibitor AR-42 and pomalidomide. Patients receive pomalidomide orally (PO) daily on days 1-21, dexamethasone PO twice weekly (BIW) or thrice weekly (TIW) weeks 1-3, and HDAC inhibitor AR-42 PO BIW or TIW on weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for at least 30 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02569320
Study type Interventional
Source Ohio State University Comprehensive Cancer Center
Contact
Status Completed
Phase Phase 1
Start date May 20, 2016
Completion date March 10, 2021
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