NCT02569320

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Recurrent Plasma Cell Myeloma

Interventions

Type	Name	Description
DRUG	Dexamethasone	Given PO
DRUG	HDAC Inhibitor AR-42	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Pomalidomide	Given PO

Timeline

• Start date: 2016-05-20
• Primary completion: 2020-11-14
• Completion: 2021-03-10
• First posted: 2015-10-06
• Last updated: 2021-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study