Study of Dara-Pembro for Multiple Myeloma Patients

Status Withdrawn

Clinical Trial Summary

This is a phase II, single-arm, open-label study in subjects with relapsed and/or refractory multiple myeloma (RRMM) comparing Pembrolizumab (Pembro) in combination with Daratumumab (Dara) to the historical control of Daratumumab.

Clinical Trial Description

Heavily pre-treated multiple myeloma patients who are treated with single agent daratumumab have been reported to have median PFS of 4 months. A median PFS of 4 months corresponds to an 8-month progression-free survival rate of 25% (based on the exponential survival distribution). For this population of patients treated with Daratumumab and Pembrolizumab, the aim is to improve the 8-month PFS rate to 50%. Thirty-three RRMM patients who have received ≥ 3 lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) will be eligible for enrollment. Sixteen (16) subjects will be enrolled in the first stage, and if at least 5 of the 16 patients are alive and progression free at 8 months, an additional 17 subjects will be enrolled. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04361851
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact
Status	Withdrawn
Phase	Phase 2
Start date	June 9, 2021
Completion date	May 2027

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See also
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