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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)
EU CTIS ID: 2024-519504-27-00
What this study is testing
Part 1 - To evaluate the safety and tolerability of condensed step-up dosing for linvoseltamab and linvoseltamab + carfilzomib treatment and select the RP3Rs for Arm A and Arm B in Part 2 Part 2 (dual) - To compare the proportion of participants who achieve MRD-negative CR at 12 months in each linvoseltamab arm (Arm A or Arm B) vs standard therapy (Arm C) Part 2 (dual) - To compare PFS in each linvoseltamab arm (Arm A or Arm B) vs standard therapy (Arm C)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- NOTE: Other protocol defined inclusion criteria apply
You likely can't join if
- 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
- NOTE: Other protocol defined exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- Korea, Republic of
- Argentina
- Japan
- Australia
- Taiwan
- United Kingdom
- Turkey
- Canada
- United States
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; Korea, Republic of; Argentina; Japan; Australia; Taiwan and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.