Clinica Universidad de Navarra | Sede Madrid - Hematology Department
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About
The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients.
Full description
Multiple myeloma (MM) is a malignant plasma cell disorder characterized by the production of monoclonal immunoglobulin (Ig) proteins or protein fragments (M proteins) that have lost their function.
JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) is an autologous chimeric antigen receptor T cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA) that is being evaluated to treat participants with multiple myeloma. The primary hypothesis is that in transplant-eligible participants with newly diagnosed multiple myeloma (NDMM), cilta-cel will significantly improve progression-free survival (PFS) and Sustained MRD-negative CR rate compared with Autologous Stem Cell Transplant (ASCT).
Approximately 750 participants (375 per arm) will be randomly assigned in a 1:1 ratio into 2 arms.
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Inclusion criteria
Participants with documented NDMM according to IMWG diagnostic criteria, for whom high-dose therapy and ASCT are part of the intended initial treatment plan.
Measurable disease, as assessed by central laboratory, at screening as defined by any of the following:
ECOG performance status of grade 0 or 1
Clinical laboratory values within prespecified range.
Exclusion criteria
Primary purpose
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Masking
750 participants in 2 patient groups
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Central trial contact
Giulia Gazzera; Chiara Pautasso
Data sourced from clinicaltrials.gov
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