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Brief Title: Daratumumab-containing Induction Effects on Stem Cells Mobilization, colLection and Engraftment in Newly Diagnosed Multiple MyelomA Patients.
Official Title: Daratumumab-containing Induction Effects on Stem Cells Mobilization, colLection and Engraftment in Newly Diagnosed Multiple MyelomA Patients (DILEMMA).
Study ID: NCT05835726
Brief Summary: Daratumumab is a human first-in-class monoclonal antibody that targets a cluster of differentiation (CD) 38, a cell surface protein that is overexpressed on multiple myeloma (MM) cells, showing significant activity in relapsed/refractory disease. More recently, it was demonstrated that the addition of daratumumab to pre-autologous hematopoietic stem cell transplant (ASCT) induction regimens in newly diagnosed multiple myeloma increased the rate of complete responses and disease-free survival. However, in consideration of the expression of CD38 antigen also by stem cells, daratumumab could exert effects on their mobilization, collection, and engraftment. The primary objective of this retrospective/prospective observational study is to investigate the impact of adding daratumumab to standard induction regimens (VTD:bortezomib-thalidomide and dexamethasone, VD: bortezomib and dexamethasone) on stem cell mobilization in patients with newly diagnosed multiple myeloma (NDMM) who are candidates for ASCT.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fondazione Policlinico Universitario A.Gemelli IRCCS, Rome, , Italy
Name: Luciana Teofili
Affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
Role: PRINCIPAL_INVESTIGATOR