Health TrialsbyHealthPanel

A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)

ConditionHigh Risk Smoldering Multiple Myeloma (HR-SMM)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegeneron Pharmaceuticals

About this trial

This study is researching an experimental drug called linvoseltamab (also called "study drug") compared to another drug called daratumumab, in participants with Smoldering Multiple Myeloma (SMM), who are at a High Risk (HR) of developing active multiple myeloma.

The aim of this study is to find out whether linvoseltamab is better than daratumumab in delaying the development of MM.

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

* What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group performance status score ≤1

SMM diagnosis per IMWG criteria as defined in the protocol

Meets HR-SMM criteria by 1 of the risk models as defined in the protocol

Disqualifiers

Evidence of myeloma-defining events attributable to the underlying plasma cell dyscrasia, as defined in the protocol

Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), plasma cell leukemia, or soft tissue plasmacytoma

History of neurodegenerative condition, progressive multifocal leukoencephalopathy, or Central Nervous System (CNS) movement disorder

History of a seizure within the 12 months of randomization

Trial design

Design model

Parallel

Treatments tested in this trial

  • Linvoseltamab

    Drug

    Administered per the protocol

  • Daratumumab

    Drug

    Administered per the protocol

Treatment groups

270 Participants
are divided into 2 treatment groups
Group A: LinvoseltamabExperimental treatment 1 intervention
Group B: DaratumumabActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) criteria

Time frame
Up to 5 years
2

Biochemical PFS per IMWG criteria

Time frame
Up to 5 years

Secondary outcomes

1

Achievement of Minimal Residual Disease (MRD) Complete Response (CR) at 10^-5 per IMWG criteria

Time frame
Up to 3 years
2

Time to death

Time frame
Up to 9 years
3

Overall Response Rate (ORR) of Partial Response or better (≥PR) per IMWG criteria

Time frame
Up to 3 years
4

Best Overall Response (BOR) per IMWG criteria

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regeneron Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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