Universitätsklinikum Freiburg | Klinik fur Dermatologie und Venerologie
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The trial aims to demonstrate the non-inferiority of subcutaneous to intravenous isatuximab administration in transplant-eligible patients with newly diagnosed multiple myeloma.
Full description
Prospective, multicentre, randomised, parallel group, open, phase III clinical trial, for patients with confirmed diagnosis of untreated multiple myeloma requiring systemic therapy.
Investigational Medicinal Product: Isatuximab, subcutaneous administration via a wearable injector system.
Randomization: Patients are randomized in one of 2 study arms (A or B) before induction therapy. Patients randomized in arm A will receive 3 cycles of the monoclonal antibody isatuximab intravenously, combined with RVd regimen (Lenalidomide, Bortezomib, Dexamethasone). Each cycle will last for 42 days. Patients in arm B will receive 3 cycles RVd plus isatuximab subcutaneously. After induction therapy, patients will receive standard intensification (usually cyclophosphamide-based mobilization therapy, stem cell collection and high-dose melphalan followed by autologous stem cell transplantation (HDM/ASCT)). End of study will be after the first HDM/ASCT.
There is one primary objective:
Demonstration of non-inferiority of subcutaneous (SC) isatuximab compared to intravenous (IV) isatuximab, both in combination with RVd, with respect to rates of VGPR or better after induction therapy (according to standard International Myeloma Working Group (IMWG) response criteria).
Key secondary objectives are:
The duration of the trial for each patients is expected to be approximately 10 months (induction and intensification treatment).
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For further details on inclusion/exclusion criteria please refer to the study protocol.
Primary purpose
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Interventional model
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514 participants in 2 patient groups
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Central trial contact
Hartmut Goldschmidt, Prof.
Data sourced from clinicaltrials.gov
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