Pilot Clinical Trial of Injection of ex Vivo Amplified G-CSF Mobilised Autologous Peripheral Blood Stem Cell Transplantation in Adult Patients With Multiple Myeloma in First Response
To check that injection of autologous peripheral blood stem cell CD34(+) "amplified ex vivo
in the presence of SCF, G-CSF and TPO in HP01 Maco pharma medium culture. ": Allows to
obtain a hematopoietic reconstitution:
1. Rapid : 7 days or less after the injection, regarding neutrophils and 15 days or less
2. Complete: numbers neutrophils and platelets respectively higher than 500/mm3 and
20000/mm3 within the times mentioned
3. Stable: no secondary neutropenia or thrombocytopenia during the year following the
injection, in the absence of recurence of the myeloma.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Hematopoietic reconstitution defined by a neutrophils number > 500/mm3 at day 7 after injection of in vitro amplified graft and by a platelets number > 20000/mm3, at day 15 after the injection of in vitro amplified graft, without transfusion.
at day 7 (neutrophils) and day 15 (platelets) after injection of in vitro amplified graft
Noel MILPIED, MS, MD
University Hospital, Bordeaux
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)