Actively Recruiting
Pharmacodynamically Monitored Linvoseltamab Dose Reduction in Relapsed Multiple Myeloma Phase I/II Trial Evaluating Safety and Feasibility
Led by Fred Hutchinson Cancer Center · Updated on 2026-03-27
30
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the safety and feasibility of reducing the dose of linvoseltamab, a bispecific antibody, in treating patients with multiple myeloma that has returned after improvement, does not respond to treatment, or is resistant to three classes of therapies including proteasome inhibitors, immunomodulatory agents, and monoclonal antibodies. This phase I/II trial aims to find optimal dosing schedules that might lower treatment side effects while maintaining disease control. Participants initially receive linvoseltamab intravenously once a week for 14 weeks, then every two weeks if the disease does not progress or side effects are unacceptable. Disease response is checked starting at week 3 and every 4 weeks thereafter. Patients achieving a very good partial response or better after at least 14 weeks are assigned to one of three groups receiving reduced doses every 4, 8, or 12 weeks. Throughout the trial, patients undergo bone marrow tests, blood sample collection, and may have CT or PET/CT scans as needed. After treatment ends, patients are followed for 3 months. During the study, participants will have regular evaluations including bone marrow aspiration and biopsy, blood tests, and imaging scans to monitor disease and safety. Researchers will measure outcomes such as early disease progression within 3 months of dose reduction and residual disease status one year after starting treatment. The trial involves frequent clinic visits for treatment and assessments, with ongoing monitoring to understand the effects of dose adjustments over time.
CONDITIONS
Brief 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 willing to sign informed consent
- Confirmed active multiple myeloma diagnosis by standard criteria
- Measurable disease as defined by specific protein or lesion levels within 14 days before registration
- Relapsed or refractory myeloma after at least 4 prior therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate blood counts and organ function based on recent lab tests
- Prior BCMA-targeted antibody-drug conjugate treatment allowed if side effects resolved
- Willing and able to comply with study visits and procedures
You will not qualify if you...
- Diagnosis of plasma cell leukemia, systemic light-chain amyloidosis (excluding myeloma-associated), Waldenstr�f6m macroglobulinemia, or POEMS syndrome
- Known brain lesions or meningeal involvement of multiple myeloma
- History of neurodegenerative disease, CNS movement disorder, or seizures within past 12 months
- Continuous systemic corticosteroid treatment above specified dose near study start
- Live vaccines within 28 days before first study drug dose
- Previous CAR T-cell or gene therapy
- Recent infections requiring hospitalization or intravenous treatment
- Uncontrolled HIV, hepatitis B or C infections
- Allergy to linvoseltamab components
- Women of childbearing potential with positive pregnancy test
- Participants unwilling to use effective contraception during and after study
- Uncontrolled illness that could interfere with compliance
- Other malignancies within past 5 years except certain treated skin or in situ cancers or tumors controlled with curative intent
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 14 weeks
Participants receive linvoseltamab intravenously once a week for weeks 1 to 14, then once every 2 weeks if there is no disease progression or unacceptable toxicity. Disease response is evaluated starting at week 3 and every 4 weeks thereafter. Participants undergo bone marrow aspiration and biopsy and blood sample collection throughout this period. CT or PET/CT scans may be performed if indicated.
Weekly visits for 14 weeks, then biweekly visits
Duration - Variable based on individual treatment continuation
Participants who achieve a very good partial response or better after at least 14 weeks of treatment enter one of three dose de-escalation cohorts, receiving linvoseltamab intravenously once every 4, 8, or 12 weeks depending on cohort assignment. Bone marrow aspiration and biopsy and blood sample collection continue throughout. CT or PET/CT scans may be performed if indicated.
Visits every 4, 8, or 12 weeks depending on cohort
Duration - 3 months
Participants are followed for 3 months after completing study treatment to monitor safety and outcomes.
Approximately 3 monthly visits
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
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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