High Risk Smoldering Multiple Myeloma study: Linvoseltamab vs Daratumumab
Official title A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
ClinicalTrials.gov ID: NCT07393282
What this study is testing
What is Linvoseltamab?
Linvoseltamab is an investigational medicine, being studied as a potential treatment for high risk smoldering multiple myeloma (hr-smm).
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 wants to find out if linvoseltamab can keep high‑risk smoldering multiple myeloma from becoming active longer than daratumumab, and to learn about side effects and how the drug behaves in the body.
- Who it's for
- Adults who have high‑risk smoldering multiple myeloma but have not yet developed active disease.
- What's involved
- Participants will receive either linvoseltamab or daratumumab, have regular blood draws to check drug levels and antibodies, and undergo safety monitoring visits.
- Time commitment
- The trial runs for several months with multiple clinic visits for treatment infusions and blood tests.
- 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
- 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 Key
You likely can't join if
- 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...
- History of neurodegenerative condition, progressive multifocal leukoencephalopathy, or Central Nervous System (CNS) movement disorder
- History of a seizure within the 12 months of randomization
- Prior exposure to any approved or investigational treatments directed against a clonal plasma cell disorder (including but not limited to...
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Cannes, Cannes, France
- Pessac, Gironde, France
- Lille, Nord, France
- Toulouse, Occitanie, France
- Nagoya, Aichi-ken, Japan
- Okayama, Okayama-ken, Japan
- Tokushima, Tokushima, Japan
- Kofu, Yamanashi, Japan
- Matsumoto-shi, Japan
- Skorzewo, Wielkopolska, Poland
- Katowice, Poland
- Suwon, Gyeonggi-do, South Korea
+ 7 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 Phoenix, Arizona, United States; Atlanta, Georgia, United States; Boston, Massachusetts, United States; Detroit, Michigan, United States; Rochester, Minnesota, United States; St Louis, Missouri, United States and 21 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.