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NCT Number: NCT06932562

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Flinders Medical Centre, Adelaide, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone.
  • Participants who defer transplant due to personal preference.
  • 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.
  • 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.
  • Participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against MM
  • 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.
  • Participants who have uncontrolled intercurrent illness.
  • Known contraindications to the use of daratumumab or lenalidomide per local prescribing information.
  • History of allogeneic hematopoietic stem cell transplantation or solid organ transplant at any time.

NOTE Other protocol defined inclusion/exclusion criteria apply.

Treatment and study plan

Linvoseltamab

Drug

Administered per the protocol

Other names: REGN5458

Daratumumab

Drug

Administered per the protocol

Lenalidomide

Drug

Administered per the protocol

Dexamethasone

Drug

Administered per the protocol

Primary outcomes

  1. Minimal Residual Disease (MRD)

    Time frame: up to 11 years

    Minimal Residual Disease (MRD) negative Complete Remission (CR) status at 10^-5 per International Myeloma Working Group (IMWG) criteria

  2. MRD negative CR status by BICR

    Time frame: up to 11 years

    MRD negative CR status at 10^-5 as determined by the Blinded Independent Central Review (BICR)

  3. Progression Free Survival (PFS) per IMWG criteria

    Time frame: up to 11 years

    defined as the time from the date of randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, where disease progression is determined per IMWG criteria.

  4. PFS as determined by BICR

    Time frame: up to 11 years

    defined as the time from the date of randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, where disease progression is determined per by BICR.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: up to 11 years

    Overall Survival (OS), measured from the date of from randomization to the date the subject's death

  2. Objective Response (OR) of Complete Response (CR)

    Time frame: up to 11 years

    To compare the proportion of patients who achieve an objective response per International Myeloma Working Group (IMWG) response criteria between the two study arms for Complete Response (CR) or better

  3. OR of Very Good Partial Response (VGPR)

    Time frame: up to 11 years

    To compare the proportion of patients who achieve an objective response per International Myeloma Working Group (IMWG) response criteria between the two study arms for VGPR or better

  4. OR of Partial Response (PR)

    Time frame: up to 11 years

    To compare the proportion of patients who achieve an objective response per International Myeloma Working Group (IMWG) response criteria between the two study arms for PR or better

  5. Sustained MRD

    Time frame: up to 11 years

    Sustained MRD negative CR (sMRD) at 10^-5 per IMWG criteria

  6. Duration of response (DOR) of stringent (s)CR

    Time frame: up to 11 years

    duration of response to best overall response of stringent sCR, per IMWG response criteria

  7. Duration of response (DOR) of CR

    Time frame: up to 11 years

    duration of response to best overall response of CR, per IMWG response criteria

  8. Duration of response (DOR) of VGPR

    Time frame: up to 11 years

    duration of response to best overall response of VGPR, per IMWG response criteria

  9. Duration of response (DOR) of PR

    Time frame: up to 11 years

    duration of response to best overall response of PR, per IMWG response criteria

  10. Time to response ≥CR

    Time frame: up to 11 years

    Time from randomization to objective response (≥CR) as per IMWG response criteria

  11. Time to response ≥VGPR

    Time frame: up to 11 years

    Time from randomization to objective response (≥VGPR) as per IMWG response criteria

  12. Time to response ≥PR

    Time frame: up to 11 years

    Time from randomization to objective response (≥PR) as per IMWG response criteria

  13. Disease progression

    Time frame: up to 11 years

    Time to disease progression per IMWG response criteria

  14. Incidence of TEAEs

    Time frame: up to 11 years

    Incidence of treatment emergent adverse events (TEAEs)

  15. Severity of TEAEs

    Time frame: up to 11 years

    Severity of treatment emergent adverse events (TEAEs)

  16. Serious Adverse Events

    Time frame: up to 11 years

    Incidence of Serious Adverse Events (SAE)

  17. Concentrations of linvoseltamab

    Time frame: up to 11 years

    Concentrations of linvoseltamab in serum over time

  18. Incidence antidrug antibodies

    Time frame: up to 11 years

    Incidence of antidrug antibodies (ADAs) to linvoseltamab

  19. Titer of ADA

    Time frame: up to 11 years

    Titer of ADA to linvoseltamab

  20. EORTC QLQ-C30 Global Health Status / Quality of Life

    Time frame: up to 11 years

    Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) The EORTC QLQ-C30 is a 30-item validated questionnaire developed to measure patient-reported quality of life using one global health status/quality of life (GHS/QoL) scale, 5 functioning scales (physical, role, emotional, cognitive, and social) ranging from from 1 = "very poor" to 7 = "excellent" and 9 symptom scales/items (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) among patients with cancer, ranging from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.

  21. EORTC QLQ-C30 Physical Functioning (PF)

    Time frame: up to 11 years

    Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire functioning scale Physical Functioning (PF). PF scale consist of 5 items, ranging from from 1 = "not at all" to 4 = "very much" higher scores indicate higher ("better") level of functioning

  22. EORTC QLQ-C30 Role Functioning (RF)

    Time frame: up to 11 years

    Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire functioning scale Role Functioning (RF). RF scale consist of 2 items, ranging from from 1 = "not at all" to 4 = "very much" higher scores indicate higher ("better") level of functioning

  23. EORTC QLQ-C30 Pain

    Time frame: up to 11 years

    Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire symptom scale Pain. Pain scale consist of 2 items, ranging from from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden

  24. EORTC QLQ-C30 Fatigue

    Time frame: up to 11 years

    Change in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire symptom scale Fatigue. Fatigue scale consist of 3 items, ranging from from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden

  25. EQ-5D-5L VAS

    Time frame: up to 11 years

    Change in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS) (EQ-5D-5L VAS).

    The EQ-5D-5L is a generic questionnaire that measures Health-Related Quality of Life (HRQoL) across 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) across 5 levels (1= no problems, 2= slight problems, 3= some problems, 4= severe problems and 5= extreme problems), higher scores indicate lower health states And a visual analogue scale (VAS). VAS scale ranging from 0 = "worst" to 100 = "best" higher score indicate higher health status

Study contacts

Contact information is provided by the study sponsor or research team.

Silvia Villa

CONTACT

[email protected]

+31 10 268 70 65

Sponsors and collaborators

Lead sponsor

European Myeloma Network B.V.

Network

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2036
Study completion
2036
First posted
Apr 17, 2025
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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