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Multiple Myeloma (MM)Phase 2/3LINKER-MM8NCT07428369

A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM)

A Phase 2/3 study testing Linvoseltamab, Bortezomib and Lenalidomide in people with Multiple Myeloma (MM), run by Regeneron Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This study is focused on participants with Newly Diagnosed Multiple Myeloma (NDMM) who are eligible for high dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma (MM)
What is being tested?
Linvoseltamab, Bortezomib and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
5 Jun 2026to 21 May 2038
Phase
Phase 2/3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have a histologically or cytologically confirmed diagnosis of multiple myeloma, which requires the presence of clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma, and at least one other criteria as defined by the SLiM (>=60%, Light chains I/U >10, Magnetic resonance imaging >1 focal lesion) CRAB (Calcium elevation, Renal insufficiency, Anemia, Bone disease) criteria
  • Participants must have measurable disease, as defined in the protocol
  • Participants must be considered eligible for high-dose chemotherapy (melphalan) and ASCT per local standard guidelines
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Must be willing to defer ASCT

Who cannot join

  • Any prior therapy for Monoclonal Gammopathy of Undetermined Significance (MGUS), Monoclonal Gammopathy of Renal Significance (MGRS), Smoldering Multiple Myeloma (SMM), or MM, with the exception of those defined in the protocol
  • Participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against MM (or another plasma cell disorder), or those whose AEs due to agents administered earlier (such as radiation and/or corticosteroids) have not recovered to a severity of grade 0 or grade 1
  • Participants with non-secretory MM, diagnosis of plasma cell leukemia (>20% circulating plasma cells), symptomatic amyloidosis (including myeloma associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes).
  • 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), or stroke within 12 months prior to study randomization
  • Another malignancy besides MM that is progressive or has required treatment in the 3 years preceding randomization with the exceptions defined in the protocol
  • NOTE: Other protocol defined inclusion/exclusion criteria apply

About this study

Official title: A Phase 2/3, Open-Label, Randomized Study of Linvoseltamab, Bortezomib and Lenalidomide (Linvo-VR) With and Without Autologous Stem Cell Transplantation (ASCT) Vs Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) in Transplant-Eligible Participants With Newly Diagnosed Multiple Myeloma

This study is focused on participants with Newly Diagnosed Multiple Myeloma (NDMM) who are eligible for high dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT).

This study is evaluating a drug called linvoseltamab in combination with standard therapies for multiple myeloma called bortezomib (V) and lenalidomide (R). This combination is abbreviated as Linvo-VR.

Read more

The aim of this study is to compare how well Linvo-VR, with and without ASCT, treats myeloma to how well the current standard of care regimen for NDMM treats myeloma. That current standard of care regimen includes the drugs daratumumab (D), bortezomib (V), lenalidomide (R), and dexamethasone (d). This combination is referred to as DVRd. The study is also evaluating if Linvo-VR treats myeloma well enough that ASCT is no longer needed with the first myeloma treatments.

The study is looking at several other research questions, including:

  • What side effects may happen from taking linvoseltamab
  • How much linvoseltamab is in the blood at different times
  • Whether the body makes antibodies against the linvoseltamab (which could make the drug less effective or could lead to side effects)
Being tested
Linvoseltamab, Bortezomib, Lenalidomide, Daratumumab, Dexamethasone
Keywords
Autologous Stem Cell Transplantation (ASCT), Transplant-Eligible, Linvoseltamab, Newly Diagnosed Multiple Myeloma (NDMM), High-dose chemotherapy, Bortezomib (V), Lenalidomide (R), Daratumumab (D), bortezomib (V), lenalidomide (R), dexamethasone (d) (DVRd)
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LinvoseltamabDrug

    Also called REGN5458, Lynozyfic™

    Administered per the protocol

  • BortezomibDrug

    Also called Velcade®

    Administered per the protocol

  • LenalidomideDrug

    Also called Revlimid®

    Administered per the protocol

  • DaratumumabDrug

    Also called Darzalex Faspro®,, Darzalex®

    Administered per the protocol

  • DexamethasoneDrug

    Also called Dexahexal®,, Decadron®

    Administered per the protocol

Study groups in NCT07428369
Study groupRoleWhat they receive
Linvo-VR with ASCTExperimentalNot described
Receives: Drug: Linvoseltamab; Drug: Bortezomib; Drug: Lenalidomide
Linvo-VR without ASCTExperimentalNot described
Receives: Drug: Linvoseltamab; Drug: Bortezomib; Drug: Lenalidomide
DVRd with ASCTActive comparatorNot described
Receives: Drug: Bortezomib; Drug: Lenalidomide; Drug: Daratumumab; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Phase 2

    Measured: Up to day 112

  2. Severity of TEAEs

    Phase 2

    Measured: Up to day 112

  3. Achievement of Complete Response or better (≥CR) per International Myeloma Working Group (IMWG) criteria

    Phase 2

    Measured: Up to day 112

  4. Minimal Residual Disease (MRD) negative CR at 10^-5 per IMWG criteria

    Phase 3

    Measured: Up to 12 months

  5. Progression Free Survival (PFS) per IMWG

    Phase 3

    Measured: Up to 5 years

Secondary outcomes (69)

  1. Occurrence of TEAEs

    Phase 2

    Measured: Up to 3.5 years

  2. Severity of TEAEs

    Phase 2

    Measured: Up to 3.5 years

  3. Occurrence of Serious Adverse Events (SAEs)

    Phase 2

    Measured: Up to 3.5 years

  4. Severity of SAEs

    Phase 2

    Measured: Up to 3.5 years

  5. Occurrence of Cytokine Release Syndrome (CRS)

    Phase 2

    Measured: Up to day 30

  6. Severity of CRS

    Phase 2

    Measured: Up to day 30

  7. Occurrence of Cell-Associated Neurotoxicity Syndrome (ICANS)

    Phase 2

    Measured: Up to day 30

  8. Severity of ICANS

    Phase 2

    Measured: Up to day 30

  9. Achievement of objective response [Partial Response or better (≥PR)] per IMWG criteria

    Measured: Up to 5 years

  10. Time to ≥PR per IMWG criteria

    Measured: Up to 5 years

  11. Time to Very Good Partial Response or better (≥VGPR) per IMWG criteria

    Measured: Up to 5 years

  12. Time to ≥CR per IMWG criteria

    Measured: Up to 5 years

  13. Achievement of MRD negative (at 10^-5 sensitivity) CR per IMWG criteria

    Measured: Up to 5 years

  14. Duration Of Response (DOR) of ≥PR per IMWG criteria

    Measured: Up to 5 years

  15. Duration of ≥VGPR per IMWG criteria

    Measured: Up to 5 years

  16. Duration of ≥CR per IMWG criteria

    Measured: Up to 5 years

  17. PFS per IMWG criteria

    Measured: Up to 5 years

  18. Second PFS (PFS2) per IMWG criteria

    Measured: Up to 5 years

  19. Overall Survival (OS)

    Measured: Up to 5 years

  20. Concentrations of total linvoseltamab in serum

    Measured: Up to 5 years

  21. Occurrence of TEAEs

    Phase 3

    Measured: Up to 5 years

  22. Severity of TEAEs

    Phase 3

    Measured: Up to 5 years

  23. Occurrence of SAEs

    Phase 3

    Measured: Up to 5 years

  24. Severity of SAEs

    Phase 3

    Measured: Up to 5 years

  25. Occurrence of second primary malignancies

    Phase 3

    Measured: Up to 5 years

  26. Change from baseline in Global Health Status (GHS) per European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30)

    Phase 3 The EORTC QLQ-C30 is a 30-item validated questionnaire developed to measure patient-reported Quality of Life (QoL).

    For GHS, scores range from 1 = "very poor" to 5 = "excellent" with higher scores indicating better functioning and positive changes from baseline indicate improvement.

    Measured: Up to 5 years

  27. Change from baseline in physical functioning per EORTC QLQ-C30

    Phase 3 The EORTC QLQ-C30 is a validated 30-item questionnaire designed to measure patient-reported quality of life.

    Physical functioning is scored from 1 'very poor' to 5 'excellent,' with higher scores indicating better functioning; positive changes from baseline indicate improvement.

    Measured: Up to 5 years

  28. Change from baseline in role functioning per EORTC QLQ-C30

    Phase 3 The EORTC QLQ-C30 is a validated 30-item questionnaire designed to measure patient-reported quality of life.

    Role functioning is scored from 1 'very poor' to 5 'excellent,' with higher scores indicating better functioning; positive changes from baseline indicate improvement.

    Measured: Up to 5 years

  29. Change from baseline in pain per EORTC QLQ-C30

    Phase 3 The EORTC QLQ-C30 is a validated 30-item questionnaire designed to measure patient-reported quality of life.

    Pain is scored from 1 = "not at all" to 9 = "very much". Higher scores indicate higher symptom burden.

    Measured: Up to 5 years

  30. Change from baseline in fatigue per EORTC QLQ-C30

    Phase 3 The EORTC QLQ-C30 is a validated 30-item questionnaire designed to measure patient-reported quality of life.

    Fatigue is scored from1 = "not at all" to 9 = "very much". Higher scores indicate higher symptom burden.

    Measured: Up to 5 years

  31. Change from baseline in disease symptoms per EORTC QLQ- Multiple Myeloma Module 20 (MY20)

    Phase 3 The EORTC QLQ-MY20 is a self-administered instrument to assess QoL in persons with MM.

    This 20-item questionnaire includes 6 items for disease symptoms. A high score for a symptom scale/item represents a high level of symptomatic problem.

    Measured: Up to 5 years

  32. Change from baseline in treatment side effects per EORTC QLQ-MY20

    Phase 3 The EORTC QLQ-MY20 is a self-administered instrument to assess QoL in persons with MM.

    This 20-item questionnaire includes 10 items for treatment side effects. A high score for a symptom scale/item represents a high level of symptomatic problem.

    Measured: Up to 5 years

  33. Change from baseline in body image per EORTC QLQ-MY20

    Phase 3 The EORTC QLQ-MY20 is a self-administered instrument to assess QoL in persons with MM.

    This 20-item questionnaire includes 1 item for treatment body image. A high score for a symptom scale/item represents a high level of symptomatic problem.

    Measured: Up to 5 years

  34. Change from baseline in future perspective per EORTC QLQ-MY20

    Phase 3 The EORTC QLQ-MY20 is a self-administered instrument to assess QoL in persons with MM.

    This 20-item questionnaire includes 3 items for treatment future perspective. A high score for a symptom scale/item represents a high level of symptomatic problem.

    Measured: Up to 5 years

  35. Change from baseline in EuroQoL-5 Dimensions 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)

    Phase 3 The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: "no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems". The EQ VAS records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labeled "Best imaginable health state" and "Worst imaginable health state".

    Measured: Up to 5 years

  36. Time to definitive deterioration in GHS per EORTC QLQ-C30

    Phase 3

    Measured: Up to 5 years

  37. Time to definitive deterioration in physical functioning per EORTC QLQ-C30

    Phase 3

    Measured: Up to 5 years

  38. Time to definitive deterioration in role functioning per EORTC QLQ-C30

    Phase 3

    Measured: Up to 5 years

  39. Time to definitive deterioration in pain per EORTC QLQ-C30

    Phase 3

    Measured: Up to 5 years

  40. Time to definitive deterioration in fatigue per EORTC QLQ-C30

    Phase 3

    Measured: Up to 5 years

  41. Time to definitive deterioration in disease symptoms per EORTC QLQ-MY20

    Phase 3

    Measured: Up to 5 years

  42. Time to definitive deterioration in treatment side effects per EORTC QLQ-MY20

    Phase 3

    Measured: Up to 5 years

  43. Time to definitive deterioration in body image per EORTC QLQ-MY20

    Phase 3

    Measured: Up to 5 years

  44. Time to definitive deterioration in future perspective per EORTC QLQ-MY20

    Phase 3

    Measured: Up to 5 years

  45. Time to definitive deterioration in EQ-5D-5L VAS

    Phase 3

    Measured: Up to 5 years

  46. Time to first improvement in GHS per EORTC QLQ-C30

    Phase 3

    Measured: Up to 5 years

  47. Time to first improvement in physical functioning per EORTC QLQ-C30

    Phase 3

    Measured: Up to 5 years

  48. Time to first improvement in role functioning per EORTC QLQ-C30

    Phase 3

    Measured: Up to 5 years

  49. Time to first improvement in pain per EORTC QLQ-C30

    Phase 3

    Measured: Up to 5 years

  50. Time to first improvement in fatigue per EORTC QLQ-C30

    Phase 3

    Measured: Up to 5 years

  51. Time to first improvement in disease symptoms per EORTC QLQ-MY20

    Phase 3

    Measured: Up to 5 years

  52. Time to first improvement in treatment side effects per EORTC QLQ-MY20

    Phase 3

    Measured: Up to 5 years

  53. Time to first improvement in body image per EORTC QLQ-MY20

    Phase 3

    Measured: Up to 5 years

  54. Time to first improvement in future perspective per EORTC QLQ-MY20

    Phase 3

    Measured: Up to 5 years

  55. Time to first improvement in EQ-5D-5L VAS

    Phase 3

    Measured: Up to 5 years

  56. Proportion with clinically meaningful improvement in GHS per EORTC QLQ-C30

    Phase 3

    Measured: Up to 5 years

  57. Proportion with clinically meaningful improvement in physical functioning per EORTC QLQ-C30

    Phase 3

    Measured: Up to 5 years

  58. Proportion with clinically meaningful improvement in role functioning per EORTC QLQ-C30

    Phase 3

    Measured: Up to 5 years

  59. Proportion with clinically meaningful improvement in pain per EORTC QLQ-C30

    Phase 3

    Measured: Up to 5 years

  60. Proportion with clinically meaningful improvement in fatigue per EORTC QLQ-C30

    Phase 3

    Measured: Up to 5 years

  61. Proportion with clinically meaningful improvement in disease symptoms per EORTC QLQ-MY20

    Phase 3

    Measured: Up to 5 years

  62. Proportion with clinically meaningful improvement in treatment side effects per EORTC QLQ-MY20

    Phase 3

    Measured: Up to 5 years

  63. Proportion with clinically meaningful improvement in body image per EORTC QLQ-MY20

    Phase 3

    Measured: Up to 5 years

  64. Proportion with clinically meaningful improvement in future perspective per EORTC QLQ-MY20

    Phase 3

    Measured: Up to 5 years

  65. Proportion of clinically meaningful improvement in EQ-5D-5L VAS

    Phase 3

    Measured: Up to 5 years

  66. Mean proportion of time with high side effect bother as measured by Functional Assessment of Cancer Therapy (FACIT)- Item Global Population 5 (GP5)

    Phase 3 FACIT-Item GP5 will be used to assess the patient-reported impact of treatment toxicity that uses a single item "I am bothered by side effects of treatment" on a 5-point scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much).

    Measured: Up to 5 years

  67. Proportion of patients with high side effect bother as measured by FACIT- Item GP5

    Phase 3

    Measured: Up to 5 years

  68. Occurrence of Anti-Drug Antibody (ADA) to linvoseltamab in serum

    Phase 3

    Measured: Up to 5 years

  69. Magnitude of ADA to linvoseltamab in serum

    Phase 3

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2026
  2. Study start5 Jun 2026 (estimated)
  3. Primary completion21 May 2038 (estimated)
  4. Study completion21 May 2038 (estimated)

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07428369
Sponsor's protocol ID
R5458-HM-2504
Other IDs
2025-524032-19-00, 2025
Acronym
LINKER-MM8
Status last verified
Jun 2026
First submitted
3 Feb 2026
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

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