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.
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).
Abdelkefi
Abderrahman
A
Centre National de Greffe de Moelle Osseuse, Tunis, Tunisia. aabdelkefi@yahoo.fr
Ladeb
Saloua
S
Torjman
Lamia
L
Othman
Tarek Ben
TB
Lakhal
Amel
A
Romdhane
Neila Ben
NB
Omri
Halima El
HE
Elloumi
Moez
M
Belaaj
Hatem
H
Jeddi
Ramzi
R
Aissaouï
Lamia
L
Ksouri
Habib
H
Hassen
Assia Ben
AB
Msadek
Fahmi
F
Saad
Ali
A
Hsaïri
Mohamed
M
Boukef
Kamel
K
Amouri
Ahlem
A
Louzir
Hechmi
H
Dellagi
Koussay
K
Abdeladhim
Abdeladhim Ben
AB
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
D020533:Angiogenesis Inhibitors; D001798:Blood Proteins; D006454:Hemoglobins; D013792:Thalidomide