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RecruitingLast updated: 22 May 2026

LUMYNA: A study recruiting people with newly diagnosed multiple myeloma who aren't eligible for a stem cell transplantation to evaluate and compare different drug treatmentsA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

LUMYNA

Clinical summary

Summary

This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible).

The main purpose of this study is to compare the effect and safety of linvoseltamab, which is a type of immunotherapy, with the effect and safety of the standard treatment.

Eligible participants will be randomly allocated (by chance) to one of two treatment arms:

  • Active Comparator Arm: DRd treatment (which consists of daratumumab, lenalidomide, and dexamethasone).
  • Experimental Arm: linvoseltamab plus DRd.

 

Conditions

This trial is treating people with newly diagnosed multiple myeloma (NDMM) who are not considered candidates for high-dose chemotherapy or autologous stem cell transplantation (ASCT)

Eligibility

Inclusion

  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

  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.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

European Myeloma Network B.V.

Scientific Title

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

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