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superior to double autologous transplantation in multiple myeloma: results of a multicenter randomized clinical trial (Retracted article. See vol. 113, pg. 6265, 2009)

Abderrahman Abdelkefi 1 Saloua Ladeb 1 Lamia Torjman 1 Tarek Ben Othman 1 Amel Lakhal 1 Halima El Omri 2 Moez Elloumi 3 Hatem Belaaj 3 Ramzi Jeddi 4 Lamia Aissaoui 4 Habib Ksouri 1 Fahmi Msadek 5 Assia Ben Hassen 1 Neila Ben Romdhane 6 Ali Saad 7 Mohamed Hsaieri 8 Kamel Boukef 9 Ahlem Amouri 10 Koussay Dellagi 10 Hechmi Louzir 10 Abdeladhim Ben Abdeladhim 1 Tunisian Multiple Myeloma Study Gr
1 CNGMO - Centre National de Greffe de la Moëlle osseuse Tunis
2 Hôpital Farhat Hached-Sousse
3 Hedi Chaker Hospital [Sfax]
4 Aziza Othmana Hospital-Tunis
5 Hôpital militaire-Tunis
6 Hôpital La Rabta [Tunis]
7 Laboratoire de cytogénétique
8 Institut National de la Santé Publique-Tunis
9 Centre National de Transfusion Sanguine-Tunis
10 Institut Pasteur de Tunis
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).
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Abderrahman Abdelkefi, Saloua Ladeb, Lamia Torjman, Tarek Ben Othman, Amel Lakhal, et al.. 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 (Retracted article. See vol. 113, pg. 6265, 2009). Blood, American Society of Hematology, 2008, 111 (4), pp.1805-1810. ⟨10.1182/blood-2007-07-101212⟩. ⟨pasteur-01375208⟩

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