Phase I/II Study of Linvoseltamab (Anti-BCMA X Anti-CD3 Bispecific Antibody) in Previously Untreated Patients with Symptomatic Multiple Myeloma
Study Description
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
-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
-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, as well as known neurocognitive conditions, 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