Multiple Myeloma Clinical Trial
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Summary
The primary objectives of the study are:
For Phase 1
To find out if linvoseltamab is safe and well tolerated
To find out what the most appropriate dosing schedule would be for future clinical trials
For Phase 2
•To find out if it works to treat multiple myeloma
The secondary objectives of the study are:
For Phase 1 and 2
To find out how linvoseltamab moves throughout the body over time (pharmacokinetics)
To find out how much B-cell maturation antigen (BCMA) participants have in their blood
To find out if the participants' immune systems respond to linvoseltamab.
Eligibility Criteria
Key Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Confirmed diagnosis of symptomatic multiple myeloma (MM) by International Myeloma Working Group (IMWG) diagnosis criteria
Measurable disease, according to the 2016 IMWG response criteria, as defined in the protocol
No prior therapy for MM, with the exception of prior emergent or palliative radiation and up to 1 month of single-agent corticosteroids, with washout periods as per the protocol
Participants must have evidence of adequate bone marrow reserves and hepatic, renal and cardiac function as defined in the protocol
Participants must be age <70 and have adequate hepatic, renal, pulmonary and cardiac function to be considered transplant-eligible. The specific thresholds for adequate organ function are as per institutional guidance.
Key Exclusion Criteria:
Receiving any concurrent investigational agent with known or suspected activity against MM, or agents targeting the A proliferation-inducing ligand (APRIL)/ Transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI)/BCMA axis
Known central nervous system (CNS) involvement with MM, known or suspected progressive multifocal leukoencephalopathy (PML), a history of neurocognitive conditions, or CNS movement disorder, or history of seizure within 12 months prior to study enrollment
Rapidly progressive symptomatic disease, (e.g. progressing renal failure or hypercalcemia not responsive to standard medical interventions), in urgent need of treatment with chemotherapy
Diagnosis of non-secretory MM, active plasma cell leukemia, primary light-chain (AL) amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or known POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Note: Other protocol-defined Inclusion/Exclusion criteria apply
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There are 10 Locations for this study
Los Angeles California, 90095, United States
Orange California, 92868, United States
Louisville Kentucky, 40202, United States
Detroit Michigan, 48201, United States
New Brunswick New Jersey, 08901, United States
New York New York, 10016, United States
Charlotte North Carolina, 28204, United States
Houston Texas, 77030, United States
Lille , 59000, France
Paris , 75015, France
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