Phase
Condition
Cancer/tumors
Bone Diseases
Lymphoproliferative Disorders
Treatment
Linvoseltamab
REGN7945+Linvoseltamab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status ≤1 as described in theprotocol
Received at least 3 lines of therapy including exposure to at least 1 anti-CD38antibody, 1 immunomodulatory imide drug (IMiD), and 1 proteasome inhibitor (PI) andhave demonstrated disease progression on or after the last therapy, as defined inthe protocol. Prior treatment with other BCMA directed immunotherapies, includingBCMA CAR-T cells and BCMA antibody-drug conjugates (Phase 1 and 2), and with BCMA xCD3 bispecific antibodies (Phase 1 only), is allowed
Participants must have the measurable disease for response assessment as describedin the protocol
Adequate hematologic, hepatic, and renal function as described in the protocol
Exclusion
Key Exclusion Criteria:
Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis (including myeloma associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly,endocrinopathy, monoclonal protein, and skin changes)
Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28days before first administration of study drug, whichever is shorter
History of allogeneic stem cell transplantation within 6 months, or autologous stemcell transplantation within 12 weeks of the start of study treatment
Treatment with systemic corticosteroid treatment with more than 10 mg per day ofprednisone or steroid equivalent within 72 hours of start of study drug
Participants who have known central nervous system (CNS) involvement with MM orknown or suspected progressive multifocal leukoencephalopathy (PML), history of aneurocognitive condition or CNS disorder, or history of seizure within 12 monthsprior to study enrollment
Live or live attenuated vaccination within 28 days before first study drugadministration with a vector that has replicative potential
Has received a COVID-19 vaccination within 1 week of planned start of studymedication as described in the protocol
Myelodysplastic syndrome or another malignancy in the past 3 years, except fornonmelanoma skin cancer, in situ carcinoma, thyroid cancer, or low-risk early stageprostate adenocarcinoma, as described in the protocol
Significant cardiovascular disease as described in the protocol
Uncontrolled infection with HIV, Hep B or Hep C infection, or other uncontrolledinfection, such as CMV, as described in the protocol
Known hypersensitivity to both allopurinol and rasburicase
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Study Design
Connect with a study center
Illawarra Cancer Care Centre
Wollongong, New South Wales 2500
AustraliaActive - Recruiting
Pindara Private Hospital
Benowa, Queensland 4217
AustraliaActive - Recruiting
Royal Adelaide Hospital
Adelaide, South Australia 5000
AustraliaActive - Recruiting
St Vincent's Hospital - Melbourne
Fitzroy, Victoria 3065
AustraliaActive - Recruiting
Alfred Hospital
Melbourne, Victoria 3004
AustraliaActive - Recruiting
University College London Hospitals
London, NW1 2PG
United KingdomActive - Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BQ
United KingdomActive - Recruiting

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