Phase 2 Myeloma Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who are relatively active and able to carry out daily activities, with a fitness score of 0 or 1 on a standard oncology scale (called ECOG performance status).
- People who have a confirmed diagnosis of active Multiple Myeloma (MM), diagnosed using standard international criteria.
- People whose myeloma can be measured and tracked to assess whether treatment is working, according to standard international guidelines.
- People (in the dose-finding phase, Part 1) whose myeloma has come back or stopped responding to all available treatments that could reasonably help, including having tried at least 3 lines of treatment — or being resistant to, or unable to tolerate, specific types of drugs including a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-CD38 antibody.
- People (in the under-skin injection phase, Part 2, and the main Phase 2 groups) whose myeloma has progressed after at least 3 prior lines of treatment including all three drug types listed above, OR whose disease has stopped responding to all three of those drug types.
- People in Phase 2, Cohort 3 who previously received a CAR-T cell therapy targeting BCMA may be eligible, provided that therapy produced at least a partial response, and — if it was the most recent treatment — it was given at least 60 days before starting this trial's treatment (confirm with trial site).
Who may not be able to join:
- People diagnosed with plasma cell leukemia, primary systemic light-chain amyloidosis (not including amyloidosis associated with myeloma), Waldenström macroglobulinemia, or POEMS syndrome.
- People who have myeloma that has spread to the brain or the lining of the brain or spinal cord.
- People whose heart is pumping at less than 40% of its normal capacity, as measured by a heart scan.
- People who have previously been treated with BCMA-targeted immunotherapies such as BCMA bispecific antibodies or BiTE therapies. Note: BCMA antibody-drug conjugates are not excluded, and BCMA-directed CAR-T therapy is not excluded for people joining Phase 2 Cohort 3.
- People who have previously received a donor stem cell transplant at any time, or their own stem cells transplanted within the 12 weeks before starting the trial treatment.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Clinical Trial Management, Regeneron Pharmaceuticals
Phone: 844-734-6643
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period; Incidence and severity of treatment-emergent adverse events (TEAEs); Incidence and severity of adverse events of special interest (AESI); Assessment of the pharmacokinetics (PK) of linvoseltamab; Concentrations of linvoseltamab in serum over time; Objective response rate (ORR) as determined by an Independent Review Committee (IRC); Incidence and severity of cytokine release syndrome (CRS) with linvoseltamab; ORR of IV linvoseltamab as assessed by investigator
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.