At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Linvoseltamab (drug)
- How long the study runs
- Study runs about 173 months (dates as stated)
- About the drug or intervention
- Linvoseltamab — drug: Administered per the protocol
- Patient visit burden
- Not specified by the sponsor
In plain English
This is an early-stage (phase 1/2) study testing a drug called linvoseltamab in adults with multiple myeloma, a type of blood cancer, that has come back or not responded to treatment. The study is paid for by Regeneron Pharmaceuticals. The trial looks at different doses and ways of giving the drug to find out if it is safe and works.
Who can take part
- Adults with a confirmed diagnosis of active multiple myeloma, judged by standard international guidelines.
- Patients must be fairly well and able to carry out light daily activities (performance status of 1 or less on a scale used by doctors).
- In most parts of the study, patients must have already tried at least 3 previous treatments, including three standard types of myeloma medicine, or their disease must no longer respond to those three types.
- If patients have had a type of cell therapy called CAR-T aimed at a marker called BCMA, it must have worked at least partly, and if it was the most recent treatment it must have been at least 60 days before starting this study drug.
- The myeloma must be measurable using standard 2016 criteria described in the study plan.
Who may not be able to
- People with plasma cell leukaemia, light-chain amyloidosis (unless linked to the myeloma), Waldenström macroglobulinaemia, or POEMS syndrome.
- People with myeloma that has spread to the brain or the tissues around it.
- People whose heart pumps less strongly than usual (pumping less than 40% on a heart scan).
- People who have had certain immunotherapies aimed at BCMA, called bispecific antibodies or BiTEs (some other BCMA treatments are allowed in one part of the study).
- People who have had a stem cell transplant from a donor at any time, or their own stem cell transplant within 12 weeks of starting the study.
- Other rules in the study plan may also apply — ask the trial team.
What taking part involves
- • Not stated — ask the trial team about how the drug is given, doses, and how long treatment lasts.
- • The study includes a dose-finding part (phase 1) and a part testing the drug under the skin (phase 1, part 2), as well as phase 2 groups.
Time commitment: Not stated — ask the trial team about how often visits happen and how long the study lasts.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 387
- Started
- 2019-01-23
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for multiple myeloma
- • Phase1/Phase2 - 387 participants
- • The main purpose of this study is to learn about the safety of linvoseltamab and to find out what is the best dose of linvoseltamab to give to patients with multiple myeloma and to look for any signs that linvoseltamab can effectively treat cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with multiple myeloma
Where?
- • Sutton - Royal Marsden Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The main purpose of this study is to learn about the safety of linvoseltamab and to find out what is the best dose of linvoseltamab to give to patients with multiple myeloma and to look for any signs that linvoseltamab can effectively treat cancer. The study is looking at several other research questions, including: * Side effects that may be experienced by people receiving linvoseltamab * How linvoseltamab works in the body * How much linvoseltamab is present in the blood * How linvoseltamab may work to treat cancer
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ at least 1 anti-CD38 antibody
- ✓ at least 1 PI
- ✓ been associated with a response of PR or better, and
- ✓ been a minimum of 60 days
What the study is looking for
- ✓activity scale (ECOG) performance status ≤ 1
- ✓Confirmed diagnosis of active Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnostic criteria
- ✓Patients must have myeloma that is response-evaluable according to the 2016 IMWG response criteria as defined in the...
- ✓Phase 1, Part 2 (SC Administration): Patients with MM whose disease meets the following criteria:
- ✓Phase 2 (Cohorts 1 and 2):
Who cannot take part
- ✗5\. History of allogeneic stem cell transplantation at any time, or autologous stem cell transplantation within 12...
- ✗Note: Other protocol defined inclusion / exclusion criteria apply
See the full criteria
Where Is This Study? (1 UK site)
Royal Marsden Hospital
Sutton SM2 5PT, United Kingdom
How to Get in Touch
Clinical Trial Administrator
Sponsor contactCONTACT
