Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-30 @ 7:45 AM
Study NCT ID:
NCT04361851
Status:
WITHDRAWN
Last Update Posted:
2022-04-26
First Post:
2020-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Dara-Pembro for Multiple Myeloma Patients
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
LCI-HEM-DRMM-DPEM-001: Phase II Study of Daratumumab-Pembrolizumab for Multiple Myeloma Patients With ≥ Three Prior Lines of Therapy
Status:
WITHDRAWN
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment due to competing studies
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 00043318 | OTHER | Advarra IRB | View |