title: Single daily dose of intravenous busulfan and melphalan as a conditioning regimen for patients with multiple myeloma undergoing autologous stem cell transplantation: a phase II trial.
abstract: We evaluated the toxicity and outcome of a conditioning regimen comprising intravenous (iv) busulfan (BU) and melphalan (MEL) in 55 patients (median age, 61 years; range, 34-71) with multiple myeloma (MM) undergoing autologous stem-cell transplantation (ASCT). In 49 patients, this was the first ASCT. At transplant, 3 patients were in complete response (CR), 8 in near CR (nCR) and 30 in partial response (PR). The conditioning regimen comprised ivBU (3.2 mg/kg in a single daily dose, days -5 to -3) and MEL (140 mg/m(2), day -2). Mucositis was the most frequent non-hematopoietic toxicity (47 patients). No patient developed sinusoidal occlusive syndrome. Febrile events were observed in 46 patients and were the cause of death in two (3.6%) transplant-related deaths. With a median follow-up of 15 months, 27 patients achieved CR/nCR (11 CR) and 21 a PR. The one-year actuarial overall and progression-free survival rates are 96% and 87%, respectively. This ivBU-containing regimen is associated with an acceptable toxicity and a high-response rate.
authors.affiliation: Hematology Service, University Hospital La Fe, Valencia, Spain.
authors.forename: Margarita
authors.initials: M
authors.lastname: Blanes
authors.forename: Javier
authors.initials: J
authors.lastname: de la Rubia
authors.forename: Juan J
authors.initials: JJ
authors.lastname: Lahuerta
authors.forename: José D
authors.initials: JD
authors.lastname: González
authors.forename: Paz
authors.initials: P
authors.lastname: Ribas
authors.forename: Carlos
authors.initials: C
authors.lastname: Solano
authors.forename: Adrián
authors.initials: A
authors.lastname: Alegre
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Sanz
mesh_terms: D000328:Adult; D000368:Aged; D002066:Busulfan / Q000494:pharmacology*; D002465:Cell Movement; D002469:Cell Separation; D018450:Disease Progression; D005260:Female; D006412:Hematopoietic Stem Cells / Q000166:cytology; D006801:Humans; D008297:Male; D008558:Melphalan / Q000494:pharmacology*; D008875:Middle Aged; D009101:Multiple Myeloma / Q000473:pathology / Q000601:surgery*; D009367:Neoplasm Staging; D033581:Stem Cell Transplantation; D015996:Survival Rate; D019172:Transplantation Conditioning / Q000379:methods*; D014184:Transplantation, Homologous
chemical_list: D002066:Busulfan; D008558:Melphalan