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

Why it matters

Who can join: the full rules

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 it's running

• Flinders Medical Centre
  Adelaide, Australia Recruiting
• Box Hill Hospital
  Box Hill, Australia Recruiting
• Canberra Hospital
  Canberra, Australia Recruiting
• Barwon Health, University Hospital Geelong
  Geelong, Australia Recruiting
• Austin Hospital
  Heidelberg, Australia Recruiting
• Nepean Cancer Centre
  Kingswood, Australia Recruiting

+9 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Roberto Mina — A.O.U. Città della Salute e della Scienza di Torino
• Study coordinator: Silvia Villa
• Email: silvia.villa@emn.org
• Phone: +31 10 268 70 65

Similar studies

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

• Tec Dara for newly diagnosed multiple myeloma with light chain amyloidosis

  This study tests whether tec listamab plus daratumumab can help newly diagnosed multiple myeloma with AL amyloidosis and whether the combination is safe.

  Recruiting Phase 2 Shanghai Zhongshan Hospital · Shanghai · NCT07638683

• Maintaining myeloma with less frequent daratumumab plus lenalidomide

  This phase 2 study tests a reduced-dosing schedule of daratumumab with lenalidomide to maintain remission in adults with multiple myeloma after stem cell transplant.

  Recruiting Phase 2 Vanderbilt-Ingram Cancer Center · Nashville, Tennessee · NCT07485647

• GR1803 injection versus daratumumab plus pomalidomide and dexamethasone for relapsed or refractory multiple myeloma

  This trial tests whether GR1803 injection works better than daratumumab combined with pomalidomide and dexamethasone for adults with relapsed or refractory multiple myeloma who have had one to three prior treatments.

  Recruiting Phase 3 Genrix (Shanghai) Biopharmaceutical Co., Ltd. · Tianjin · NCT07452198

• Linvoseltamab vs. Daratumumab in high-risk smoldering myeloma

  This study tests whether linvoseltamab can delay progression to active myeloma better than daratumumab in people with high-risk smoldering multiple myeloma.

  Recruiting at 33 sites Phase 3 Regeneron Pharmaceuticals · Phoenix, Arizona and 32 other locations · NCT07393282

• Belantamab Mafodotin or Daratumumab with VRd for Newly Diagnosed High-Risk Myeloma

  This study tests whether belantamab mafodotin plus standard multiple myeloma drugs works better than daratumumab plus the same drugs for people newly diagnosed and ineligible for transplant.

  Recruiting Phase 3 PrECOG, LLC. · La Crosse, Wisconsin · NCT07285239

• Etentamig plus daratumumab versus daratumumab‑lenalidomide‑dexamethasone for newly diagnosed multiple myeloma in patients not eligible for transplant

  This trial will test whether adding the investigational drug etentamig to daratumumab helps control disease and is safe in adults newly diagnosed with multiple myeloma who cannot have a transplant.

  Recruiting at 49 sites Phase 2/3 AbbVie · Scottsdale, Arizona and 48 other locations · NCT07095452

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.