Actively Recruiting
A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed/Refractory Multiple Myeloma
Led by Regeneron Pharmaceuticals · Updated on 2026-04-13
186
Participants Needed
7
Research Sites
568 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is researching an experimental drug called REGN7945 in combination with another experimental drug called linvoseltamab, (also known as REGN5458) (each individually called a "study drug" or "study drugs" when combined). This study is the first time REGN7945 will be tested in humans. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after several other therapies had failed. The aim of the study is to see how safe, tolerable, and effective REGN7945 is when given in combination with linvoseltamab, compared with linvoseltamab alone. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug(s) * How many people treated with REGN7945 and linvoseltamab compared to linvoseltamab alone have improvement of their multiple myeloma and by how much * How long people benefit from receiving REGN7945 in combination with linvoseltamab compared with linvoseltamab alone * How much study drug(s) is in the blood at different times * Whether the body makes antibodies against the study drugs(s) (which could make the study drug(s) less effective or could lead to side effects) * If there is any change in pain and cancer-related symptoms, how well people are able to function, and their quality of life when taking the study drug(s)
CONDITIONS
Official Title
A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status 1 or less
- Received at least 3 lines of therapy including exposure to at least 1 anti-CD38 antibody, 1 immunomodulatory imide drug, and 1 proteasome inhibitor
- Demonstrated disease progression on or after last therapy
- Prior treatment with BCMA-directed immunotherapies allowed
- Measurable disease for response assessment
- Adequate hematologic, hepatic, and renal function
You will not qualify if you...
- Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome
- Treatment with systemic anti-cancer therapy within 5 half-lives or 28 days before study drug start
- Allogeneic stem cell transplantation within 6 months or autologous stem cell transplantation within 12 weeks before treatment
- Systemic corticosteroid treatment with more than 10 mg prednisone or equivalent within 72 hours before treatment
- Known CNS involvement with multiple myeloma, progressive multifocal leukoencephalopathy, neurocognitive conditions, CNS disorders, or seizure history within 12 months
- Live or live attenuated vaccination with replicative vector within 28 days before study drug
- COVID-19 vaccination within 1 week before study drug
- Myelodysplastic syndrome or other malignancy in past 3 years except certain low-risk cancers
- Significant cardiovascular disease
- Uncontrolled infections including HIV, Hepatitis B or C, or CMV
- Known hypersensitivity to both allopurinol and rasburicase
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Trial Site Locations
Total: 7 locations
1
Illawarra Cancer Care Centre
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
2
Pindara Private Hospital
Benowa, Queensland, Australia, 4217
Actively Recruiting
3
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
4
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
5
St Vincents Hospital Melbourne
Melbourne, Victoria, Australia, 3065
Actively Recruiting
6
University College London Hospitals
London, United Kingdom, NW1 2PG
Actively Recruiting
7
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BQ
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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