Trial comparing treatments for Relapsed and/or Refractory Multiple Myeloma (RRMM)
Official title 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)
ClinicalTrials.gov ID: NCT07222761
What this study is testing
What is Linvoseltamab?
Linvoseltamab is an investigational medicine, being studied as a potential treatment for relapsed and/or refractory multiple myeloma (rrmm).
Also referred to as REGN5458, Lynozyfic™.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study compares the safety and effectiveness of linvoseltamab alone or with carfilzomib to standard therapies in people whose multiple myeloma has come back or not responded to 1–3 prior treatments. It also looks at side effects, drug levels in the blood, and whether the body makes antibodies against the drug.
- Who it's for
- Adults with relapsed or refractory multiple myeloma who have had at least one but no more than three previous treatments.
- What's involved
- Participants may receive linvoseltamab alone or with carfilzomib, or a standard treatment. They will have regular clinic visits, blood tests, and other assessments to monitor safety and response.
- Time commitment
- The study lasts several months, with multiple scheduled visits for treatment, monitoring, and follow‑up.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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...
- 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 Key
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)...
- Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Atlanta, Georgia, United States
- New York, New York, United States
- Stony Brook, New York, United States
- Columbus, Ohio, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Benowa, Queensland, Australia
- Brisbane, Queensland, Australia
- Southport, Queensland, Australia
- East Melbourne, Victoria, Australia
- Heidelberg, Victoria, Australia
- Melbourne, Victoria, Australia
- Perth, Western Australia, Australia
- Adelaide, Australia
- Belo Horizonte, Minas Gerais, Brazil
- Curitiba, Paraná, Brazil
- Niterói, Rio de Janeiro, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Joinville, Santa Catarina, Brazil
- Lages, Santa Catarina, Brazil
+ 24 more site(s).
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, but 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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Atlanta, Georgia, United States; New York, New York, United States; Stony Brook, New York, United States; Columbus, Ohio, United States; Dallas, Texas, United States; Houston, Texas, United States and 38 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.