A Phase 1/2 interventional study of Linvoseltamab in Multiple Myeloma, sponsored by Regeneron Pharmaceuticals. Recruiting at 40 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Regeneron Pharmaceuticals · Phase 1/2, Interventional, and Treatment
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:
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's planned enrollment of 387 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.
Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion 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:
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.
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.
Patients with MM whose disease meets the following criteria:
Patients must be triple- refractory, defined as being refractory* to prior treatment with at least 1 PI, 1 IMiD, and an anti-CD38 antibody.
AND, for ALL patients, if they have relapsed after a BCMA-directed CAR-T cellular therapy then:
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
Phase 1 has two parts. Part 1, consists of linvoseltamab intravenous (IV) dose escalation and Part 2, consists of subcutaneous (SC) administration.
Drug: Linvoseltamab
Low Dose of linvoseltamab IV monotherapy.
Drug: Linvoseltamab
High Dose of linvoseltamab IV monotherapy.
Drug: Linvoseltamab
Anti-interleukin (IL)-6 receptor (R) prophylactic therapy followed by high dose of IV linvoseltamab monotherapy.
Drug: Linvoseltamab
Administered per the protocol
Also known as: REGN5458, Lynozyfic™
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
Phase 1 and Phase 2 for Japanese cohort only
Time frame: Up to 28 days
Incidence and severity of treatment-emergent adverse events (TEAEs)
Phase 1
Time frame: Up to 5 years
Incidence and severity of adverse events of special interest (AESI)
Phase 1
Time frame: Up to 5 years
Assessment of the pharmacokinetics (PK) of linvoseltamab
Phase 1 part 2
Time frame: Up to 5 years
Concentrations of linvoseltamab in serum over time
Phase 2, for Japanese cohort only
Time frame: Up to 5 years
Objective response rate (ORR) as determined by an Independent Review Committee (IRC)
Phase 2, cohorts 1 and 2
Time frame: Up to 5 years
Incidence and severity of cytokine release syndrome (CRS) with linvoseltamab
Phase 2, cohort 3
Time frame: Up to 5 years
ORR of IV linvoseltamab as assessed by investigator
Phase 2, cohort 3
Time frame: Up to 5 years
Concentrations of linvoseltamab in the serum over time
Phase 1 part 1 and Phase 2
Time frame: Up to 5 years
Incidence over time of anti-drug antibodies (ADAs) to linvoseltamab
Phase 1 and Phase 2
Time frame: Up to 5 years
Titer of anti-drug antibodies (ADAs) to linvoseltamab over time
Phase 1 and Phase 2
Time frame: Up to 5 years
Incidence of neutralizing antibodies (NAb) to linvoseltamab over time
Phase 1 and Phase 2
Time frame: Up to 5 years
Duration of response (DOR) as determined by an IRC, measured using the IMWG criteria
Phase 2, cohorts 1 and 2
Time frame: Up to 5 years
DOR as determined by an investigator, measured using the International Myeloma Working Group (IMWG) criteria
Phase 1 and Phase 2
Time frame: Up to 5 years
Progression-free survival (PFS) as determined by an IRC, measured using the IMWG criteria
Phase 2
Time frame: Up to 5 years
PFS as determined by an investigator, measured using the IMWG criteria
Phase 1 and Phase 2
Time frame: Up to 5 years
Rate of minimal residual disease (MRD) negative status, using the IMWG criteria
Phase 1
Time frame: Up to 5 years
Rate of MRD negative status
Phase 2
Time frame: Up to 5 years
Overall survival (OS)
Phase 1 and Phase 2
Time frame: Up to 5 years
ORR as measured as determined by blinded IRC, as measured using the IMWG criteria
Phase 1, part 1 dose level 7 (DL7)
Time frame: Up to 5 years
ORR as determined by the investigator, measured using the IMWG criteria
Phase 1 and Phase 2
Time frame: Up to 5 years
Effects of linvoseltamab on health-related quality of life (HRQoL) and patient-reported symptoms and functioning per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Phase 2 The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
Time frame: Up to 5 years
Effects of linvoseltamab on HRQOL and patient-reported symptoms and functioning per Quality of Life Questionnaire-Multiple Myeloma module 20 [QLQ-MY20])
Phase 2 The EORTC QLQ-MY20 is a self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). A high score represents a high level of symptoms or problems.
Time frame: Up to 5 years
Effects of linvoseltamab on HRQOL and patient-reported symptoms and functioning per EuroQoL-5 Dimension-3 Level Scale [EQ-5D-3L])
Phase 2 The EQ-5D-3L is a self-administered generic standardized health status measure, consisting of an EQ-5D descriptive system and an EQ visual analog scale. The EQ-5D-3L descriptive system assesses 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 3-level scale: no problems, some problems, and extreme problems. The EQ visual analog scale component is a vertical visual analog scale used by patients to rate their health.
Time frame: Up to 5 years
Change in patient-reported global health status/QoL per EORTC QLQ-C30
Phase 2
Time frame: Baseline up to Up to 5 years
Time to definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30
Phase 2
Time frame: Up to 5 years
Effects of linvoseltamab on general health status per EQ-5D-3L
Phase 2
Time frame: Up to 5 years
Effects of linvoseltamab on patient-reported functions and symptoms per EORTC QLQ-C30
Phase 2
Time frame: Up to 5 years
Effects of linvoseltamab on patient-reported functions and symptoms per QLQ-MY20
Phase 2
Time frame: Up to 5 years
Incidence and severity of TEAEs with linvoseltamab
Phase 2
Time frame: Up to 5 years
Incidence and severity of AESIs with linvoseltamab
Phase 2
Time frame: Up to 5 years
Plan to share: Yes — All IPD that underlie results in a publication.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Regeneron Pharmaceuticals