DARA-RVD for Smoldering Multiple Myeloma
(PRISM Trial)

Recruiting in Palo Alto (17 mi)

+6 other locations

Omar Nadeem, MD - Dana-Farber Cancer ...

Overseen byOmar Nadeem, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Omar Nadeem, MD

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

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

Eligibility Criteria

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

Your test results need to be within certain numbers.

I can take care of myself and perform daily activities.

My cancer can be tracked with a specific DNA test for minimal disease.

+7 more

Exclusion Criteria

You currently have HIV, hepatitis B, hepatitis C, or active COVID-19 infection.

Pregnant or nursing women

I haven't had or been treated for another cancer in the last 2 years.

+7 more

Participant Groups

The study tests a combination of drugs: Daratumumab (Darzalex Faspro), Lenalidomide (Revlimid), Bortezomib (Velcade), and Dexamethasone, on preventing smoldering multiple myeloma from becoming symptomatic. It aims to understand the effectiveness of this drug mix.

1Treatment groups

Experimental Treatment

Group I: Daratumumab, Bortezomib,Lenalidomide,DexamethasoneExperimental Treatment4 Interventions

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Cycle Length is 28 days. The names of the study drugs involved in this study are: * Daratumumab * Bortezomib * Lenalidomide * Dexamethasone

Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Velcade for: