Tests linvoseltamab in adults with relapsed or refractory multiple myeloma
Tests linvoseltamab for safety and dosing in adults with returning or resistant myeloma.
Plain-language title generated from the registry record
Registry title: Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma
Key facts
- Where
- Goyang and Seoul, South KoreaSee the 4 sites
- Phase
- Phase 1/2
Where in South Korea
- National Cancer Center KoreaGoyang, South KoreaTaking people
- Seoul National University Cancer HospitalSeoul, South KoreaTaking people
- The Catholic University of Korea, Seoul ST. Mary's HospitalSeoul, South KoreaTaking people
- Yonsei University College of Medicine (Severance Hospital)Seoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Regeneron Pharmaceuticals
- Trial code
- NCT03761108EU 2024-511454-45-00
- Record updated
- 26 October 2026
- Original description
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.Read full original descriptionShow less
Phase 1/2 FIH Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Patients With Relapsed or Refractory Multiple Myeloma
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
Inclusion: Eastern Cooperative Oncology Group (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 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:; 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:; 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:; 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:; Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR; 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.
Exclusion: 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; 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.