title: High-dose idarubicin, busulphan and melphalan for autologous stem cell transplantation in multiple myeloma responsive to DAV chemotherapy: comparison with a historical control.
abstract: Since 1997, 32 newly diagnosed multiple myeloma patients responsive to DAV chemotherapy were autografted with idarubicin-intensified busulphan-melphalan (ida-bu-mel). Main endpoints of the study were transplant-related toxicity, overall survival (OS) and progression-free survival (PFS). The results were compared with a historical control group of 38 patients treated with the 'standard' bu-mel regimen. Concerning time to engraftment, no significant difference was observed between the two groups, while toxicity was significantly higher in the intensive conditioning group, regarding grade IV mucositis, duration of profound neutropenia, incidence of infections and platelet requirement. Five-year OS and PFS are 73 versus 78% and 37 versus 48% for the intensive and standard regimen, respectively (p value not significant). The ida-bu-mel schedule appears to be a feasible and effective regimen for newly diagnosed multiple myeloma patients; nevertheless, no apparent benefit in OS and PFS arises from the comparison with a historical control treated with standard bu-mel, which is better tolerated and at least equally effective.
authors.affiliation: Dipartimento di Biotecnologie Cellulari ed Ematologia, Università La Sapienza, Rome, Italy.
authors.forename: Saveria
authors.initials: S
authors.lastname: Capria
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Petrucci
authors.forename: Alessandro
authors.initials: A
authors.lastname: Pulsoni
authors.forename: Michela
authors.initials: M
authors.lastname: Ribersani
authors.forename: Erminia
authors.initials: E
authors.lastname: Baldacci
authors.forename: Maria Stefania
authors.initials: MS
authors.lastname: de Propris
authors.forename: Giovanna
authors.initials: G
authors.lastname: Meloni
mesh_terms: D000328:Adult; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002066:Busulfan / Q000008:administration & dosage; D003606:Dacarbazine / Q000008:administration & dosage; D005260:Female; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage; D007239:Infections / Q000209:etiology / Q000401:mortality / Q000628:therapy; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D008875:Middle Aged; D052016:Mucositis / Q000209:etiology / Q000401:mortality / Q000628:therapy; D009101:Multiple Myeloma / Q000150:complications / Q000401:mortality / Q000628:therapy*; D009503:Neutropenia / Q000209:etiology / Q000401:mortality / Q000628:therapy; D015376:Nimustine / Q000008:administration & dosage; D036102:Peripheral Blood Stem Cell Transplantation; D019172:Transplantation Conditioning; D014182:Transplantation, Autologous; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D000903:Antibiotics, Antineoplastic; D018906:Antineoplastic Agents, Alkylating; D015376:Nimustine; D014750:Vincristine; D003606:Dacarbazine; D002066:Busulfan; D008558:Melphalan; D015255:Idarubicin