Actively Recruiting
Response-Based Dose Reduction of Linvoseltamab in the Treatment of Relapsed, Refractory, or Triple-Class Relapsed/Refractory Multiple Myeloma
Led by Fred Hutchinson Cancer Center · Updated on 2026-03-27
30
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I/II trial evaluates the safety and feasibility of early, response-based dose reduction of linvoseltamab in the treatment of patients multiple myeloma that has come back after a period of improvement (relapsed), that does not respond to treatment (refractory), or that is resistant to three classes of therapeutic agents, including proteasome inhibitors, immunomodulatory agents, and monoclonal antibodies (triple-class relapsed/refractory). Linvoseltamab is a bispecific antibody. Upon administration, linvoseltamab binds to the BCMA protein on cancer cells and the CD3 protein on T cells (a type of immune cell). This generates an immune response that stimulates the T cells to kill the cancer cells. Optimal dosing schedules of linvoseltamab have not yet been determined. Reducing the dosage of linvoseltamab may reduce treatment-related side effects while maintaining long-term disease outcomes.
CONDITIONS
Official Title
Response-Based Dose Reduction of Linvoseltamab in the Treatment of Relapsed, Refractory, or Triple-Class Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ability to understand and provide informed consent
- Confirmed diagnosis of active multiple myeloma by established criteria
- Measurable disease as defined by specific protein levels or lesion size
- Relapsed or refractory myeloma after at least 4 prior lines of therapy including proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody
- ECOG performance status of 0 or 1
- Adequate blood counts and organ function measured within 14 days before registration
- Prior BCMA-targeted antibody-drug conjugate treatment allowed if adverse events have resolved to grade 1 or lower
- Willingness and ability to comply with clinic visits and study procedures
You will not qualify if you...
- Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis (excluding myeloma-associated amyloidosis), Waldenstr�f6m macroglobulinemia, or POEMS syndrome
- Known brain lesions or meningeal involvement from multiple myeloma
- History of neurodegenerative conditions, CNS movement disorders, or seizures within 12 months prior to enrollment
- Continuous systemic corticosteroid treatment above 10 mg prednisone or equivalent within 72 hours before study drug
- Live or live attenuated vaccines within 28 days before first dose
- Previous chimeric antigen receptor (CAR) T cell therapy or gene therapy
- Infection requiring hospitalization or IV treatment within 2 weeks before first dose
- Uncontrolled HIV, hepatitis B, or hepatitis C infection
- Known allergy to linvoseltamab components
- Women of childbearing potential with positive pregnancy test
- Unwillingness to use highly effective contraception during and after the study
- Concurrent uncontrolled illness including infections, heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance
- Other malignancies within past 5 years except certain treated cancers or in situ tumors
- Participation in other investigational agent studies
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
M
Madhav Dhodapkar, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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