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NCT06932562 | NOT YET RECRUITING | Multiple Myeloma

A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant
Sponsor:

European Myeloma Network B.V.

Brief 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 with the effect and safety of the standard treatment.

Condition or disease

Multiple Myeloma

Intervention/treatment

Linvoseltamab

Daratumumab

Lenalidomide

Dexamethasone

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 1000 participants
Masking : NONE
Primary Purpose : TREATMENT
Official 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
Actual Study Start Date : 2025-09
Estimated Primary Completion Date : 2036-12
Estimated Study Completion Date : 2036-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant

Location Details

NCT06932562

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