Four-Drug cocktail aims to halt smoldering myeloma before it strikes

NCT ID NCT04775550

Ongoing Disease control Sponsor: Omar Nadeem, MD Source: ClinicalTrials.gov ↗

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This phase 2 trial tests whether a combination of four drugs—daratumumab, bortezomib, lenalidomide, and dexamethasone—can stop high-risk smoldering multiple myeloma from progressing to active multiple myeloma. Participants must be 18 or older and meet specific high-risk criteria. The study measures how many patients achieve minimal residual disease (MRD) negativity, meaning no cancer cells are detectable in the bone marrow.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: daratumumab, bortezomib, lenalidomide, and dexamethasone
What this could lead to: If successful, this combination could prevent or delay smoldering multiple myeloma from progressing to active multiple myeloma, potentially reducing the need for more intensive treatments later.
What could go wrong: This is a phase 2 trial with only 61 participants, so results may not apply to everyone. The drugs can cause side effects like infections, nerve damage, and blood clots, and the combination may not work for all patients.

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Conditions

The condition(s) this trial relates to.

smoldering plasma cell myeloma plasma cell myeloma prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIGH RISK SMOLDERING MULTIPLE MYELOMA MULTIPLE MYELOMA

Contacts and locations

Locations

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
Dana-Farber Brigham Cancer Center

South Weymouth, Massachusetts, 02190, United States
Dana-Farber Brigham Cancer Center - Foxborough

Foxborough, Massachusetts, 02035, United States
Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute - Merrimack Valley

Methuen, Massachusetts, 01844, United States
Stamford Hospital

Stamford, Connecticut, 06902, United States

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