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Linvoseltamab versus standard daratumumab‑lenalidomide‑dexamethasone for adults with newly diagnosed, transplant‑ineligible multiple myeloma

A Randomized, Open-Label, Controlled Phase 3 Study of Comparing Daratumumab, Lenalidomide and Dexamethasone Induction Followed by Linvoseltamab Versus Continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients

Phase 3 Interventional European Myeloma Network B.V. · NCT06932562

This trial tests whether linvoseltamab works better or is safer than the standard daratumumab‑lenalidomide‑dexamethasone combination in adults newly diagnosed with multiple myeloma who are not eligible for transplant.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorEuropean Myeloma Network B.V. Research network
Drugs / interventionsdaratumumab, chemotherapy, radiation, linvoseltamab
Locations59 sites (Adelaide and 58 other locations)
Trial IDNCT06932562 on ClinicalTrials.gov

What this trial studies

This randomized Phase 3 study assigns adults with newly diagnosed, transplant‑ineligible multiple myeloma to receive either the experimental bispecific antibody linvoseltamab or the standard regimen of daratumumab plus lenalidomide and dexamethasone. Eligible participants must have measurable disease and an ECOG performance status of 0–2, and treatments are given per protocol with scheduled safety and response assessments. Key outcomes include efficacy measures such as response rates and progression‑free survival alongside detailed adverse event monitoring. The trial is sponsored by the European Myeloma Network with Regeneron as a collaborator and is being conducted at multiple centers in Australia.

Who should consider this trial

Good fit: Adults with symptomatic, newly diagnosed multiple myeloma who are not candidates for high‑dose chemotherapy and autologous stem cell transplant, have measurable disease, and ECOG 0–2 are the intended participants.

Not a fit: Patients who are transplant‑eligible, have non‑secretory myeloma, active plasma cell leukemia, concurrent amyloidosis or other excluded diagnoses, or prior myeloma therapy are unlikely to benefit from joining this study.

Why it matters

Potential benefit: If successful, linvoseltamab could provide a more effective or better‑tolerated first‑line option for transplant‑ineligible patients with newly diagnosed multiple myeloma.

How similar studies have performed: Other early‑phase studies of BCMA‑targeting bispecific antibodies have shown promising responses, but frontline use of linvoseltamab in transplant‑ineligible patients is being tested in larger randomized Phase 3 trials.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria.
2. Participants must not be considered a candidate for high-dose chemotherapy (HDT) and ASCT, as described in the protocol.
3. Participants must have measurable disease as defined in the protocol.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
5. Participants must have clinical laboratory values within a prespecified range.

Exclusion Criteria:

1. International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone.
2. Participants who defer transplant due to personal preference.
3. Participants with non-secretory MM, active plasma cell leukemia, known light-chain (AL) amyloidosis in the presence of a concurrent diagnosis of myeloma, any other form of amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome.
4. Any prior therapy for monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), or MM, with the exception of:

   * focal radiation and/or
   * a short course of corticosteroids as defined in the protocol.
5. Participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against MM
6. Participants who have known central nervous system (CNS) or meningeal involvement with MM or known or suspected progressive multifocal leukoencephalopathy (PML), a history of a neurocognitive condition or CNS movement disorder, OR a history of seizure, transient ischemic attack (TIA), stroke or seizure within 12 months prior to study C1D1.
7. Participants who have uncontrolled intercurrent illness.
8. Known contraindications to the use of daratumumab or lenalidomide per local prescribing information.
9. History of allogeneic hematopoietic stem cell transplantation or solid organ transplant at any time.

NOTE Other protocol defined inclusion/exclusion criteria apply.

Where this trial is running

Adelaide and 58 other locations

+9 more sites — see ClinicalTrials.gov for the full list.

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 MyelomaTransplant ineligibleNewly diagnosedLinvoseltamabBCMA X CD3 bispecific antibodyCD38 antibodyLenalidomide
Last reviewed 2026-06-13 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.