title: Single autologous stem-cell transplantation followed by maintenance therapy with thalidomide is superior to double autologous transplantation in multiple myeloma: results of a multicenter randomized clinical trial.
abstract: From April 2003 to December 2006, 195 patients with de novo symptomatic myeloma and younger than 60 years of age were randomly assigned to receive either tandem transplantation up front (arm A, n = 97) or one autologous stem-cell transplantation followed by a maintenance therapy with thalidomide (day + 90, 100 mg per day during 6 months) (arm B, n = 98). Patients included in arm B received a second transplant at disease progression. In both arms, autologous stem-cell transplantation was preceded by first-line therapy with thalidomide-dexamethasone and subsequent collection of peripheral blood stem cells with high-dose cyclophosphamide (4 g/m(2)) and granulocyte colony stimulating factor. Data were analyzed on an intent-to-treat basis. With a median follow-up of 33 months (range, 6-46 months), the 3-year overall survival was 65% in arm A and 85% in arm B (P = .04). The 3-year progression-free survival was 57% in arm A and 85% in arm B (P = .02). Up-front single autologous transplantation followed by 6 months of maintenance therapy with thalidomide (with second transplant in reserve for relapse or progression) is an effective therapeutic strategy to treat multiple myeloma patients and appears superior to tandem transplant in this setting. This study was registered at www.ClinicalTrials.gov as (NCT 00207805).
authors: Centre National de Greffe de Moelle Osseuse, Tunis, Tunisia. aabdelkefi@yahoo.fr
authors: Abderrahman
authors: A
authors: Abdelkefi
authors: Saloua
authors: S
authors: Ladeb
authors: Lamia
authors: L
authors: Torjman
authors: Tarek Ben
authors: TB
authors: Othman
authors: Amel
authors: A
authors: Lakhal
authors: Neila Ben
authors: NB
authors: Romdhane
authors: Halima El
authors: HE
authors: Omri
authors: Moez
authors: M
authors: Elloumi
authors: Hatem
authors: H
authors: Belaaj
authors: Ramzi
authors: R
authors: Jeddi
authors: Lamia
authors: L
authors: Aissaouï
authors: Habib
authors: H
authors: Ksouri
authors: Assia Ben
authors: AB
authors: Hassen
authors: Fahmi
authors: F
authors: Msadek
authors: Ali
authors: A
authors: Saad
authors: Mohamed
authors: M
authors: Hsaïri
authors: Kamel
authors: K
authors: Boukef
authors: Ahlem
authors: A
authors: Amouri
authors: Hechmi
authors: H
authors: Louzir
authors: Koussay
authors: K
authors: Dellagi
authors: Abdeladhim Ben
authors: AB
authors: Abdeladhim
mesh_terms: D000328:Adult; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use; D001798:Blood Proteins / Q000378:metabolism; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000097:blood / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D009367:Neoplasm Staging; D018579:Patient Selection; D033581:Stem Cell Transplantation / Q000379:methods*; D016019:Survival Analysis; D013792:Thalidomide / Q000627:therapeutic use*; D013997:Time Factors; D020858:Tissue and Organ Harvesting / Q000379:methods; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D001798:Blood Proteins; D006454:Hemoglobins; D013792:Thalidomide