Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-28 @ 2:45 PM
Study NCT ID:
NCT04775550
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-02
First Post:
2021-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DARA RVD For High Risk SMM
Sponsor:
Omar Nadeem, MD
Organization:
Study Overview
Official Title:
B- PRISM (Precision Intervention Smoldering Myeloma): A Phase II Trial of Combination of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in High- Risk Smoldering Multiple Myeloma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
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:
PRISM
Brief Summary:
The purpose of this research study is to learn whether the combination of daratumumab SC ( Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone works in treating smoldering multiple myeloma and preventing progression to active or symptomatic multiple myeloma.
The names of the study drugs involved in this study are:
* Daratumumab (also called Darzalex Faspro)
* Bortezomib (also called Velcade)
* Lenalidomide (also called Revlimid)
* Dexamethasone
The names of the study drugs involved in this study are:
* Daratumumab (also called Darzalex Faspro)
* Bortezomib (also called Velcade)
* Lenalidomide (also called Revlimid)
* Dexamethasone
Detailed Description:
The purpose of this research study is to learn whether the combination of daratumumab (Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone works in treating smoldering multiple myeloma and preventing progression to active or symptomatic multiple myeloma.
This combination of drugs are considered "investigational" which means it has not been approved in this combination for smoldering myeloma by the United States Food and Drug Administration.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits
The names of the study drugs involved in this study are:
* Daratumumab (also called Darzalex Faspro)
* Bortezomib (also called Velcade)
* Lenalidomide (also called Revlimid)
* Dexamethasone
Participants may be treated for up to 24 months and will be followed for up to 3 years.
It is expected that about 30 people will take part in this research study.
This research study is a Phase II clinical trial, which tests the effectiveness of an investigational drug(s). The investigational drugs used in this research study are daratumumab (Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone. "Investigational" means that the FDA (the U.S. Food and Drug Administration) has not approved the combination of daratumumab (Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone as a treatment regimen for the specific disease.
This combination of drugs are considered "investigational" which means it has not been approved in this combination for smoldering myeloma by the United States Food and Drug Administration.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits
The names of the study drugs involved in this study are:
* Daratumumab (also called Darzalex Faspro)
* Bortezomib (also called Velcade)
* Lenalidomide (also called Revlimid)
* Dexamethasone
Participants may be treated for up to 24 months and will be followed for up to 3 years.
It is expected that about 30 people will take part in this research study.
This research study is a Phase II clinical trial, which tests the effectiveness of an investigational drug(s). The investigational drugs used in this research study are daratumumab (Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone. "Investigational" means that the FDA (the U.S. Food and Drug Administration) has not approved the combination of daratumumab (Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone as a treatment regimen for the specific disease.
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?: