NCT04775550

DARA RVD For High Risk SMM

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Omar Nadeem, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• High-risk Smoldering Multiple Myeloma
• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Daratumumab	Subcutaneous, dosage per protocol, dose days vary per cycle. Cycle =28 days
DRUG	Bortezomib	Subcutaneous, dosage per protocol, dose days vary per cycle. Cycle =28 days
DRUG	Lenalidomide	Oral, dosage per protocol, days 1-21 per cycle
DRUG	Dexamethasone	Oral, dosage per protocol, dose days vary per cycle. Cycle =28 days

Timeline

• Start date: 2021-03-08
• Primary completion: 2026-12-20
• Completion: 2030-12-08
• First posted: 2021-03-01
• Last updated: 2025-07-02

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study