A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment (NCT05828511)
Phase 1/2 Study of Linvoseltamab (Anti-BCMA X Anti-CD3 Bispecific Antibody) in Previously Untreated Patients With Symptomatic Multiple Myeloma
🩺 Plain-English Summary (8th-Grade Level)
This study is researching an experimental drug called linvoseltamab (called "study drug"). The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are eligible for high dose chemotherapy with autologous stem cell transplantation (transplant-eligible) or ineligible for autologous stem cell transplantation (transplant-ineligible). The aim of this clinical trial is to study the safety, tolerability (how the body reacts to the drug), and effectiveness (tumor shrinkage) of linvoseltamab in study participants with NDMM as a first step in determining if the study drug has a role in the treatment of NDMM. This study consists of 2 phases: * In Phase 1 Parts A and B, the study drug will be given to participants to study the side effects of the study drug and to establish the regimen (initial doses and full dose) of the study drug to be given to participants in Phase 2. * In Phase 1 Part C, the study drug will be given to participants to study the side effects when using different initial doses of the study drug. * In Phase 2, the study drug will be given to more participants to continue to assess the side effects of the study drug and to evaluate the activity of the study drug to shrink the tumor (multiple myeloma) in participants with NDMM. The study is looking at several research questions, including: * What side effects may happen from taking linvoseltamab? * What the right dosing regimen is for linvoseltamab? * How many participants treated with linvoseltamab have improvement of their disease and for how long? * The effects of linvoseltamab study treatment before and after transplant * How much linvoseltamab is in the blood at different times? * Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects).
Who can join: Review the eligibility criteria below.
Location: University of California Los Angeles (UCLA) — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (32 Sites)
Showing the first 25 of 32 sites.
- University of California Los Angeles (UCLA) — Los Angeles, California
- UC Irvine Health — Orange, California
- Colorado Blood Cancer Institute/SCRI — Denver, Colorado
- Norton Cancer Institute — Louisville, Kentucky
- Karmanos Cancer Institute — Detroit, Michigan
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island — Mineola, New York
- Perlmutter Cancer Center — New York, New York
- Columbia University _ New York Presbyterian — New York, New York
- Stony Brook University Hospital — Stony Brook, New York
- Levine Cancer Institute — Charlotte, North Carolina
- Duke University Health System (DUHS) — Durham, North Carolina
- The University of Texas MD Anderson Cancer Center — Houston, Texas
- Centre Hospitalier Universitaire (CHU) de Poitiers — Poitiers, Vienne
- CHU De Lille — Lille,
- Centre Hospitalier Universitaire (CHU) Montpellier — Montpellier,
- Hopital Saint Louis — Paris,
- University Hospitals Pitie Salpetriere - Charles Foix — Paris,
- Hopital Prive d'Antony — Antony, Île-de-France Region
- Hopital Necker — Paris, Île-de-France Region
- Gustave Roussy — Villejuif, Île-de-France Region
- Hospital Germans Trias i Pujol — Badalona, Barcelona
- Hospital Universitario Quiron Salud Madrid — Pozuelo de Alarcón, Madrid
- Clinica Universidad de Navarra — Pamplona, Navarre
- Hospital Universitario Central de Asturias — Oviedo, Principality of Asturias
📞 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 Multiple Myeloma
- Ixazomib + Pomalidomide + Dexamethasone In MM — Boston, Massachusetts
- A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma — Birmingham, Alabama
- Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant — Tampa, Florida
- MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb — Beverly Hills, California
- A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma — Phoenix, Arizona
- A Study of Carfilzomib, Lenalidomide, Vorinostat, and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma — Hackensack, New Jersey
Explore by condition: All Multiple Myeloma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.