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Testing linvoseltamab for newly diagnosed multiple myeloma patients

Phase 1/2 Study of Linvoseltamab (Anti-BCMA X Anti-CD3 Bispecific Antibody) in Previously Untreated Patients With Symptomatic Multiple Myeloma

Phase1; Phase2 Interventional Regeneron Pharmaceuticals · NCT05828511

This study is testing a new drug called linvoseltamab to see if it can safely help adults with newly diagnosed multiple myeloma before they start other treatments.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment149 (estimated)
Ages18 Years and up
SexAll
SponsorRegeneron Pharmaceuticals Industry-sponsored
Drugs / interventionschemotherapy, radiation, linvoseltamab
Locations32 sites (Los Angeles, California and 31 other locations)
Trial IDNCT05828511 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the experimental drug linvoseltamab in adults with recently diagnosed multiple myeloma who have not yet received treatment. The study is divided into two phases: Phase 1 focuses on assessing the safety and tolerability of the drug, while Phase 2 evaluates its effectiveness in reducing tumor size. Participants may be eligible for high dose chemotherapy with autologous stem cell transplantation or may be ineligible for such treatment. The trial aims to establish the drug's role in treating this condition.

Who should consider this trial

Good fit: Ideal candidates are adults under 70 years old with symptomatic multiple myeloma who have not received prior treatment.

Not a fit: Patients with prior treatment for multiple myeloma or those with severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a new treatment option for patients with newly diagnosed multiple myeloma.

How similar studies have performed: Other studies have shown promise with similar approaches in treating multiple myeloma, but this specific drug is being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
2. Confirmed diagnosis of symptomatic Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnosis criteria, as described in the protocol
3. Response-evaluable myeloma, according to the 2016 IMWG response criteria, as defined in the protocol
4. No prior therapy for MM, with the exception of prior emergent or palliative radiation and up to 1 month of single-agent corticosteroids, with washout periods as per the protocol
5. Participants must have evidence of adequate bone marrow reserves and hepatic, renal and cardiac function as defined in the protocol
6. Participants must be age \<70 and have adequate hepatic, renal, pulmonary and cardiac function to be considered transplant-eligible. The specific thresholds for adequate organ function are as per institutional guidance.

Key Exclusion Criteria:

1. Receiving any concurrent investigational agent with known or suspected activity against MM, or agents targeting the A proliferation-inducing ligand (APRIL)/ Transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI)/BCMA axis
2. Known Central Nervous System (CNS) involvement with MM, known or suspected Progressive Multifocal Leukoencephalopathy (PML), a history of neurocognitive conditions, or CNS movement disorder, or history of seizure within 12 months prior to study enrollment
3. Rapidly progressive symptomatic disease, (e.g. progressing renal failure or hypercalcemia not responsive to standard medical interventions), in urgent need of treatment with chemotherapy
4. Diagnosis of non-secretory MM, active plasma cell leukemia primary light-chain (AL) amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or known POEMS syndrome (Plasma cell dyscrasia with polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes)

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Where this trial is running

Los Angeles, California and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple MyelomaNewly Diagnosed Multiple MyelomaAutologous Stem Cell TransplantationCluster of Differentiation 3BCMAHigh Dose chemoTherapyInternational Myeloma Working Group
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.