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This article was retracted on June 11, 2009.
Blood, 15 February 2008, Vol. 111, No. 4, pp. 1805-1810.
Prepublished online as a Blood First Edition Paper on November 8, 2007; DOI 10.1182/blood-2007-07-101212.
 Previous Article | Table of Contents | Next Article 
CLINICAL TRIALS AND OBSERVATIONS
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
Abderrahman Abdelkefi1,
Saloua Ladeb1,
Lamia Torjman1,
Tarek Ben Othman1,
Amel Lakhal1,
Neila Ben Romdhane2,
Halima El Omri3,
Moez Elloumi4,
Hatem Belaaj4,
Ramzi Jeddi5,
Lamia Aissaouï5,
Habib Ksouri1,
Assia Ben Hassen1,
Fahmi Msadek6,
Ali Saad7,
Mohamed Hsaïri8,
Kamel Boukef9,
Ahlem Amouri10,
Hechmi Louzir10,
Koussay Dellagi10,
Abdeladhim Ben Abdeladhim1, on behalf of the Tunisian Multiple Myeloma Study Group
1 Centre National de Greffe de Moelle Osseuse, Tunis;
2 Hôpital La Rabta, Tunis;
3 Hôpital Farhat Hached, Sousse;
4 Hôpital Hédi Chaker, Sfax;
5 Hôpital Aziza Othmana, Tunis;
6 Hôpital militaire, Tunis;
7 Laboratoire de cytogénétique, Hôpital Farhat Hached, Sousse;
8 Institut National de la Santé Publique, Tunis;
9 Centre National de Transfusion Sanguine, Tunis; and
10 Institut Pasteur de Tunis, Tunisia
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/m2) 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).
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