NCT04361851

Study of Dara-Pembro for Multiple Myeloma Patients

LCI-HEM-DRMM-DPEM-001: Phase II Study of Daratumumab-Pembrolizumab for Multiple Myeloma Patients With ≥ Three Prior Lines of Therapy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Experimental

Timeline

• Start date: 2021-06-09
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2020-04-24
• Last updated: 2022-04-26

Regulatory

• FDA-regulated drug study