Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT04176718
Status:
RECRUITING
Last Update Posted:
2025-10-07
First Post:
2019-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM
Sponsor:
Andrew Yee, MD
Organization:
Study Overview
Official Title:
A Phase II Study of Daratumumab With Weekly Carfilzomib, Pomalidomide, and Dexamethasone in Relapsed and Refractory Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is studying the combination of daratumumab with weekly carfilzomib, pomalidomide, and dexamethasone in people with relapsed and refractory multiple myeloma. Relapsed and Refractory Multiple Myeloma is the condition of returned or previous treatment resistant Multiple Myeloma.
This research study involves two study drugs and two standard of care drugs.
* The names of the study drugs involved in this study are:
* Carfilzomib
* Daratumumab
* The names of the standard of care drugs involved in this study are:
* Dexamethasone
* Pomalidomide
This research study involves two study drugs and two standard of care drugs.
* The names of the study drugs involved in this study are:
* Carfilzomib
* Daratumumab
* The names of the standard of care drugs involved in this study are:
* Dexamethasone
* Pomalidomide
Detailed Description:
This phase II, multicenter, open-label study is studying daratumumab in combination with weekly carfilzomib, pomalidomide, and dexamethasone in people with relapsed and refractory multiple myeloma who have received at least one prior therapy and who have had previous treatment with both lenalidomide and a proteasome inhibitor.
* The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. This research study involves two study drugs and two standard of care drugs.
* The names of the study drugs involved in this study are:
* Carfilzomib
* Daratumumab
* The names of the standard of care drugs involved in this study are:
* Dexamethasone
* Pomalidomide
* A total of 43 participants will be enrolled to this trial
* The U.S. Food and Drug Administration (FDA) has not approved Daratumumab, and Carfilzomib for use in treatment of Multiple Myeloma.
* The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. This research study involves two study drugs and two standard of care drugs.
* The names of the study drugs involved in this study are:
* Carfilzomib
* Daratumumab
* The names of the standard of care drugs involved in this study are:
* Dexamethasone
* Pomalidomide
* A total of 43 participants will be enrolled to this trial
* The U.S. Food and Drug Administration (FDA) has not approved Daratumumab, and Carfilzomib for use in treatment of Multiple Myeloma.
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?:
False
Is an FDA AA801 Violation?: