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Looking for participantsPhase1/Phase2

Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma

Sponsor: Regeneron Pharmaceuticals

NCT ID: NCT03761108

View on ClinicalTrials.gov ↗

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

Multiple Myeloma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

CD38PR

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
Key Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 2. Confirmed diagnosis of active Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnostic criteria 3. Patients must have myeloma that is response-evaluable according to the 2016 IMWG response criteria as defined in the protocol. * Phase 1, Part 1 (Dose Escalation): Patients with MM who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit, either through disease relapse, treatment refractory disease or intolerance of the therapy and including either: a. Progression on or after at least 3 lines of therapy, or intolerance of therapy, including a proteasome inhibitor, an Immunomodulatory agent (IMiD), and an anti-CD38 antibody, OR b. Progression on or after an anti-CD38 antibody and have disease that is "double refractory" to a proteasome inhibitor and an IMiD, or intolerance of therapy. The anti-CD38 antibody may have been administered alone or in combination with another agent such as a proteasome inhibitor (PI). Refractory disease is defined as lack of response or relapse within 60 days of last treatment. * Phase 1, Part 2 (SC Administration): Patients with MM whose disease meets the following criteria: a. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR b. Patients must be triple-refractory, defined as being refractory to prior treatment with at least 1 anti-CD38 antibody, a proteasome inhibitor, and an IMiD. * Phase 2 (Cohorts 1 and 2): Patients with MM whose disease meets the following criteria: a. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR b. Patients must be triple- refractory, defined as being refractory\* to prior treatment with at least 1 PI, 1 IMiD, and an anti-CD38 antibody. * Phase 2 (Cohort 3): Patients with MM whose disease meets the following criteria: 1. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR 2. Patients must be triple- refractory, defined as being refractory\* to prior treatment with at least 1 PI, 1 IMiD, and an anti-CD38 antibody. * Refractory disease is defined as progression during treatment or within 60 days after completion of therapy, or \<25% response to therapy. AND, for ALL patients, if they have relapsed after a BCMA-directed CAR-T cellular therapy then: • Treatment with a CAR-T must have been associated with a response of PR or better, and • If CAR-T cellular therapy was the most recent prior therapy, excluding corticosteroids, then treatment must have been a minimum of 60 days prior to treatment with linvoseltamab. Key Exclusion Criteria: 1\. Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis, (excluding myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 2. Patients with known MM brain lesions or meningeal involvement 3. Cardiac ejection fraction \<40% by echocardiogram or multi-gated acquisition scan (MUGA) 4. Prior treatment with BCMA-directed immunotherapies, including BCMA bispecific antibodies and BiTEs. Note: BCMA antibody-drug conjugates are not excluded and BCMA-directed CAR-T treatment is not excluded in Phase 2 Cohort 3. 5\. History of allogeneic stem cell transplantation at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment Note: Other protocol defined inclusion / exclusion criteria apply

Where Is This Study? (1 UK site)

Royal Marsden Hospital

Sutton SM2 5PT, United Kingdom

WITHDRAWN
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

Clinical Trial Administrator

Sponsor contact

CONTACT

844-734-6643 clinicaltrials@regeneron.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-04