Linvoseltamab vs. Daratumumab in high-risk smoldering myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial compares linvoseltamab to daratumumab in adults with high-risk smoldering multiple myeloma who have not yet developed active disease. Participants are monitored for time to progression, safety, drug levels in blood, and the development of antibodies against the study drugs. The study also collects data on side effects and tolerability to understand the safety profiles of the two therapies. Eligibility requires good performance status, confirmed HR-SMM per protocol criteria, and absence of myeloma-defining events. Investigational treatments directed at clonal plasma cells are not allowed prior to enrollment.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group performance status score ≤1
2. SMM diagnosis per IMWG criteria as defined in the protocol
3. Meets HR-SMM criteria by 1 of the risk models as defined in the protocol

Key Exclusion Criteria:

1. Evidence of myeloma-defining events attributable to the underlying plasma cell dyscrasia, as defined in the protocol
2. Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), plasma cell leukemia, or soft tissue plasmacytoma
3. History of neurodegenerative condition, progressive multifocal leukoencephalopathy, or Central Nervous System (CNS) movement disorder
4. History of a seizure within the 12 months of randomization
5. Prior exposure to any approved or investigational treatments directed against a clonal plasma cell disorder (including but not limited to conventional chemotherapies, radiotherapy, immunomodulatory drugs, proteasome inhibitors, anti-CD38 antibodies). Ongoing treatment with other monoclonal antibodies (eg, infliximab, rituximab) or other treatments likely to interfere with study procedures or results, as described in the protocol.

NOTE: Other protocol defined inclusion/exclusion criteria apply

Where it's running

• Mayo Clinic Phoenix, Mayo Clinic Building
  Phoenix, Arizona, United States Recruiting
• Emory University - Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting
• Dana Farber / Harvard Cancer Center
  Boston, Massachusetts, United States Recruiting
• Barbara Ann Karmanos Cancer Institute - Detroit
  Detroit, Michigan, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Washington University School of Medicine in St. Louis
  St Louis, Missouri, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Daratumumab for acquired immune thrombotic thrombocytopenic purpura

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.