🏛️ Verified NIH Record • Updated 2026-07-07

A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma (NCT06140524)

Phase 2 Dose-Ranging and Interception Study of Linvoseltamab in Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Regeneron Pharmaceuticals

🩺 Plain-English Summary (8th-Grade Level)

This study is researching an investigational drug called linvoseltamab ("study drug") in participants at moderate risk of developing multiple myeloma (about 3 to 10% average annual risk), a group that consists of patients with precancerous conditions called High-Risk Monoclonal Gammopathy of Undetermined Significance (HR-MGUS) and Non-High-Risk Smoldering Multiple Myeloma (NHR-SMM). The primary purpose of the study is to understand how well the study drug can eliminate abnormal plasma cells and laboratory signs of HR-MGUS and NHR-SMM. The study is looking at several other research questions, including: * How many participants treated with linvoseltamab have improvement of their HR-MGUS or NHR-SMM? * What side effects may happen from taking the study drug? * How much study drug is in the blood at different times? * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects).

Who can join: Review the eligibility criteria below.

Location: Johns Hopkins Hospital — Baltimore, Maryland

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (39 Sites)

Showing the first 25 of 39 sites.

  • Johns Hopkins Hospital — Baltimore, Maryland
  • Dana-Farber Cancer Institute — Boston, Massachusetts
  • University of Michigan Health — Ann Arbor, Michigan
  • NYU Langone Health Perlmutter Cancer Center — New York, New York
  • Stony Brook University Hospital — Stony Brook, New York
  • Thomas Jefferson University Hospital — Philadelphia, Pennsylvania
  • University of Washington — Seattle, Washington
  • Algemeen Ziekenhuis (AZ) Klina — Brasschaat, Antwerpen
  • AZ St.-Elisabeth Herentals vzw — Herentals, Antwerp
  • AZ Sint Maarten Algemeen Ziekenhuis Emmaus — Mechelen, Flanders
  • Algemeen Ziekenhuis St Jan Brugge Oostende Av — Bruges, West-Vlaanderen
  • Algemeen Ziekenhuis AZ Delta — Roeselare, West-Vlaanderen
  • Ziekenhuis Netwerk Antwerpen Cadix, Hematology — Antwerp,
  • Centre Hospitalier Universitaire De Poitiers — Poitiers, New Aquitaine
  • Institut Curie — Paris, Île-de-France Region
  • Galway University Hospital — Galway, Connacht
  • Cork University Hospital — Cork,
  • Mater Misericordiae University Hospital — Dublin,
  • Istituto Romagnolo per lo Studio Dei Tumori Dino Amadori — Meldola, Forli-Cesena
  • IRCCS Ospedale Policlinico San Martino — Genoa, Genova
  • San Paolo Hospital — Milan, Lombardy
  • Azienda Ospedaliero Universitaria (AOU) SS. Antonio e Biagio e Cesare Arrigo — Alessandria, Piedmont
  • UOC Ematologia e Terapia Cellulare - PO Mazzoni AST Ascoli Piceno — Ascoli Piceno,
  • Universita degli Studi di Pavia - Fondazione IRCCS Policlini — Pavia,
  • Ospedale Santa Maria delle Croci — Ravenna,

📞 Contact the Study Coordinator

Phone: (844) 734-6643

Email: clinicaltrials@regeneron.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Monoclonal Gammopathy of Undetermined Significance (MGUS)

Explore by condition: All Monoclonal Gammopathy of Undetermined Significance (MGUS) clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗