DARA-RVD for Smoldering Multiple Myeloma
(PRISM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that other concurrent chemotherapy, immunotherapy, or investigational therapies are not allowed, so it's best to discuss your current medications with the study team.
Is the DARA-RVD treatment safe for humans?
The DARA-RVD treatment, which includes drugs like daratumumab, lenalidomide, bortezomib, and dexamethasone, has been shown to be generally safe in patients with relapsed/refractory multiple myeloma. Common side effects include low blood cell counts, nerve damage, and infections, but these are considered manageable.12345
What makes the DARA-RVD drug unique for treating smoldering multiple myeloma?
The DARA-RVD drug combines four different medications—Bortezomib, Daratumumab, Dexamethasone, and Lenalidomide—each with distinct mechanisms to target multiple aspects of smoldering multiple myeloma, potentially offering a more comprehensive approach compared to treatments using fewer components.678910
What data supports the effectiveness of the drug combination DARA-RVD for Smoldering Multiple Myeloma?
Who Is on the Research Team?
Omar Nadeem, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for adults over 18 with high-risk smoldering multiple myeloma, who meet specific criteria but do not have active symptoms. Participants must be in good enough health to perform daily activities and agree to birth control measures if applicable. They cannot have had treatment for active myeloma or other cancers within the last two years, among other exclusions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a combination of daratumumab, bortezomib, lenalidomide, and dexamethasone for up to 24 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bortezomib
- Daratumumab
- Dexamethasone
- Lenalidomide
Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Omar Nadeem, MD
Lead Sponsor
Omar Nadeem
Lead Sponsor
Janssen Pharmaceuticals
Industry Sponsor
Joaquin Duato
Janssen Pharmaceuticals
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Pharmaceuticals
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University
Janssen, LP
Industry Sponsor
Joaquin Duato
Janssen, LP
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen, LP
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University