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Blood, 15 February 2008, Vol. 111, No. 4, pp. 1805-1810.
Prepublished online as a Blood First Edition Paper on November 8, 2007October 16, 2007; DOI 10.1182/blood-2007-07-101212.
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Submitted July 16, 2007
Accepted September 13, 2007
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 Abdelkefi*, Saloua Ladeb, Lamia Torjman, Tarek Ben Othman, Amel Lakhal, Neila Ben Romdhane, Halima El Omri, Moez Elloumi, Hatem Belaaj, Ramzi Jeddi, Lamia Aissaoui, Habib Ksouri, Assia Ben Hassen, Fahmi Msadek, Ali Saad, Mohamed Hsairi, Kamel Boukef, Ahlem Amouri, Hechmi Louzir, Koussay Dellagi, and Abdeladhim Ben Abdeladhim
Department of Hematology, Centre National de Greffe de Moelle Osseuse, Tunis, Tunisia
Department of Hematology, Hopital La Rabta, Tunis, Tunisia
Department of Hematology, Hopital Farhat Hached, Sousse, Tunisia
Department of Hematology, Hopital Hedi Chaker, Sfax, Tunisia
Department of Hematology, Hopital Aziza Othmana, Tunis, Tunisia
Department of Immunology, Centre National de Greffe de Moelle Osseuse, Tunis, Tunisia
Department of Hematology, Hopital militaire, Tunis, Tunisia
Department of Cytogenetics, Hopital Farhat Hached, Sousse, Tunisia
Department of Statistics, Institut National de la Sante Publique, Tunis, Tunisia
Department of Hematology, Centre National de Transfusion Sanguine, Tunis, Tunisia
Department of Cytogenetics, Institut Pasteur de Tunis, Tunis, Tunisia
Department of Immunology, Institut Pasteur de Tunis, Tunis, Tunisia
* Corresponding author; email: aabdelkefi{at}yahoo.fr.
From April 2003 to December 2006, 195 patients with de novo symptomatic myeloma and less 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 63% in arm A, and 88% in arm B (P= .05). The 3-year progression-free survival was 57% in arm A, and 85% in arm B (P= .03). Up-front single autologous transplant 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 http://clinicaltrails.gov (NCT 00207805).
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