Health TrialsbyHealthPanel

A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

ConditionRelapsed and/or Refractory Multiple Myeloma (RRMM)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegeneron Pharmaceuticals

About this trial

This study is researching a drug called linvoseltamab (also called "study drug") either given alone or in combination with another anti-myeloma drug called carfilzomib, compared to several standard treatments for progressive Multiple Myeloma (MM) after at least 1 but no more than 3 prior therapies.

The aim of this study is to see if the safety and efficacy of linvoseltamab alone or in combination with carfilzomib can deliver better outcomes (deeper and longer responses that help extend life) than standard treatment options.

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

Participant with RRMM who received at least 1 but not more than 3 prior lines of therapy, which must have included treatment with lenalidomide and either a Protease Inhibitor (PI) or anti-CD38 monoclonal antibody

Eastern Cooperative Oncology Group (ECOG) performance status score ≤2

Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy

Disqualifiers

Prior treatment with a T cell-based immunotherapy targeting BCMA, including BCMA-directed bispecific antibodies, Bispecific T-cell Engagers (BiTEs), and Chimeric Antigen Receptor (CAR) T cells. Antibody-drug conjugates targeting BCMA (eg, belantamab mafodotin) are not excluded

Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)

Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement

History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy (PML), or CNS movement disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Linvoseltamab

    Drug

    Administered per the protocol

  • Carfilzomib

    Drug

    Administered per the protocol

  • Daratumumab

    Drug

    Administered per the protocol

  • Dexamethasone

    Drug

    Administered per the protocol

  • Pomalidomide

    Drug

    Administered per the protocol

  • Bortezomib

    Drug

    Administered per the protocol

Treatment groups

915 Participants
are divided into 5 treatment groups
Group A: Part 1: Arm AExperimental treatment 1 intervention
Group B: Part 1: Arm BExperimental treatment 2 interventions
Group C: Part 2: Arm AExperimental treatment 1 intervention
Group D: Part 2: Arm BExperimental treatment 2 interventions
Group E: Part 2: Arm CExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Occurrence of Treatment Emergent Adverse Events (TEAEs)

Part 1

Time frame
Up to 5 years
2

Severity of TEAEs

Part 1

Time frame
Up to 5 years
3

Occurrence of Adverse Events of Special Interest (AESI)

Part 1

Time frame
Up to 5 years
4

Severity of AESIs

Part 1

Time frame
Up to 5 years

Secondary outcomes

1

Occurrence of grade ≥2 Cytokine Release Syndrome (CRS)

Part 1

Time frame
Up to 28 days
2

Timing of grade ≥2 CRS

Part 1

Time frame
Up to 28 days
3

Overall Survival (OS)

Part 2

Time frame
Up to 7 years
4

Achievement of Partial Response (PR) or better per IMWG response criteria as determined by BIRC

Part 2

Time frame
Up to 5 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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