Relapsed/Refractory Multiple Myeloma study: Linvoseltamab vs Tocilizumab
Official title Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS)
ClinicalTrials.gov ID: NCT07609940
What this study is testing
What is Linvoseltamab?
Linvoseltamab is an investigational injectable medicine being studied for relapsed or refractory multiple myeloma.
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 aims to see how safe, tolerable, and effective linvoseltamab is when given after tocilizumab, and to identify any side effects from the pre‑treatment.
- Who it's for
- Adults with relapsed or refractory multiple myeloma who have already received at least four prior treatments, including a proteasome inhibitor, an immunomodulatory drug, and an anti‑CD38 antibody.
- What's involved
- Participants will receive a dose of tocilizumab before their first linvoseltamab injection, then continue with linvoseltamab. They will attend scheduled clinic visits and undergo routine blood tests and other safety monitoring.
- Phase 4: studies an already-approved treatment
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
- Disease progression on or after at least 4 prior lines of therapy including a(n) Protease Inhibitor (PI), Immunomodulatory imide Drug (IMiD), 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
- Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia...
- Known myeloma brain lesions or meningeal involvement
- History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy [PML], or Central Nervous System (CNS) movement disorder NOTE...
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- St. Petersburg, Florida, United States
- Baton Rouge, Louisiana, United States
- Bethesda, Maryland, United States
- Reno, Nevada, United States
- Lubbock, Texas, United States
- Tacoma, Washington, United States
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 Los Angeles, California, United States; St. Petersburg, Florida, United States; Baton Rouge, Louisiana, United States; Bethesda, Maryland, United States; Reno, Nevada, United States; Lubbock, Texas, United States and 1 more location. 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.