title: A new conditioning regimen involving total marrow irradiation, busulfan and cyclophosphamide followed by autologous PBSCT in patients with advanced multiple myeloma.
abstract: The overall survival of patients with advanced multiple myeloma (MM) undergoing high-dose chemotherapy and autologous stem cell transplantation (SCT) depends mainly on the quality of response. Thus, to improve the response rate, a new intensified high-dose chemoradiotherapy was evaluated in a phase I/II study. After induction chemotherapy, 89 patients (median age 51 years, range 32-60 years) with MM stage II/III received a conditioning regimen with total marrow irradiation (9 Gy), busulfan (12 mg/kg) and cyclophosphamide (120 mg/kg) followed by SCT. Regimen-related toxicity according to WHO criteria and response rates defined by EBMT/IBMTR were analyzed. The main toxicity was mucositis grade III/IV in 76%, and fever grade >I in 75% of patients. Three patients developed reversible veno-occlusive disease. Transplant-related mortality was 2%. Among patients with de novo and pretreated MM, a CR rate of 48 and 41%, respectively, was documented. With a median follow-up of 45 months, the actuarial median durations of event-free survival (EFS) and overall survival (OS) after transplant were 29 and 61 months for the whole group, 36 and 85 months for patients with de novo MM, respectively. Thus, administration of this intensified conditioning regimen was associated with tolerable toxicity, a high response rate and long EFS and OS.
authors.affiliation: Department of Hematology and Oncology, Tübingen, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Einsele
authors.forename: M
authors.initials: M
authors.lastname: Bamberg
authors.forename: W
authors.initials: W
authors.lastname: Budach
authors.forename: H
authors.initials: H
authors.lastname: Schmidberger
authors.forename: C F
authors.initials: CF
authors.lastname: Hess
authors.forename: B
authors.initials: B
authors.lastname: Wörmann
authors.forename: C
authors.initials: C
authors.lastname: Meisner
authors.forename: C
authors.initials: C
authors.lastname: Straka
authors.forename: H
authors.initials: H
authors.lastname: Hebart
authors.forename: L
authors.initials: L
authors.lastname: Trümper
authors.forename: N
authors.initials: N
authors.lastname: Kröger
authors.forename: A R
authors.initials: AR
authors.lastname: Zander
authors.forename: S
authors.initials: S
authors.lastname: Hegewisch-Becker
authors.forename: D K
authors.initials: DK
authors.lastname: Hossfeld
authors.forename: H
authors.initials: H
authors.lastname: Schmidt
authors.forename: P
authors.initials: P
authors.lastname: Müller
authors.forename: G
authors.initials: G
authors.lastname: Schlimok
authors.forename: B
authors.initials: B
authors.lastname: Hertenstein
authors.forename: D
authors.initials: D
authors.lastname: Peest
authors.forename: B
authors.initials: B
authors.lastname: Metzner
authors.forename: N
authors.initials: N
authors.lastname: Frickhofen
authors.forename: L
authors.initials: L
authors.lastname: Kanz
authors.forename: W I
authors.initials: WI
authors.lastname: Bensinger
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D001853:Bone Marrow / Q000528:radiation effects; D002066:Busulfan / Q000008:administration & dosage; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications / Q000401:mortality / Q000628:therapy*; D036102:Peripheral Blood Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D018714:Radiotherapy, Adjuvant / Q000379:methods; D012074:Remission Induction / Q000379:methods; D016019:Survival Analysis; D019172:Transplantation Conditioning / Q000009:adverse effects / Q000379:methods*; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D003520:Cyclophosphamide; D002066:Busulfan