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 Aissaouï, Habib Ksouri, Assia Ben Hassen, Fahmi Msadek, Ali Saad, Mohamed Hsaïri, Kamel Boukef, Ahlem Amouri, Hechmi Louzir, Koussay Dellagi, Abdeladhim Ben Abdeladhim, Tunisian Multiple Myeloma Study Group, M Younes, N Bergaoui, I Bejia, M Elloumi, S Hdiji, H Belaaj, M Mdaffer, T Souissi, S Baklouti, J Hachicha, M Frikha, N Toumi, H El Omri, A Latiri, A Khelif, A Saad, S Ben Ahmed, E Bouajina, K Ben Haj Slama, L Zakraoui, R Hajri, M Laatar, M Ben Dridi, K Bouslama, M Abdallah, S M'rad, S Hamzaoui, I Ksontini, A Abdelkefi, T Ben Othman, L Torjman, S Ladeb, A Lakhal, A Ben Abdeladhim, H Ksouri, A Ben Hassen, A Hafsia, Z Belhadj, L Aissaoui, R Jeddi, R Ben Lakhal, B Meddeb, H Ben Abid, N Ben Romdhane, H Houmene, S Sellami, M Elleuch, C Ben Hadj Yahia, R Zouari, L Chaabouni, M Kchir, S Turki, K Ben Abdelghenni, R Goucha, A Kheder, H Ben Maiz, L Ben Hassine, N Khalfallah, M Karoui, F Msadek, B Louzir, S Othmani, S Ktari, L Rokbani, K Boukef, M Maamar, H Slama, L Ben Hamed, F Jenhani, N Mojaat, F Ben Ayed, A Mezlini, S Khalfallah, H Boussen, B Aissaoui, K Dellagi, H Louzir, I Safra, M Ben Ahmed, Y Galaï, A Amouri, S Guermazi, M Hsairi, Abderrahman Abdelkefi, Saloua Ladeb, Lamia Torjman, Tarek Ben Othman, Amel Lakhal, Neila Ben Romdhane, Halima El Omri, Moez Elloumi, Hatem Belaaj, Ramzi Jeddi, Lamia Aissaouï, Habib Ksouri, Assia Ben Hassen, Fahmi Msadek, Ali Saad, Mohamed Hsaïri, Kamel Boukef, Ahlem Amouri, Hechmi Louzir, Koussay Dellagi, Abdeladhim Ben Abdeladhim, Tunisian Multiple Myeloma Study Group, M Younes, N Bergaoui, I Bejia, M Elloumi, S Hdiji, H Belaaj, M Mdaffer, T Souissi, S Baklouti, J Hachicha, M Frikha, N Toumi, H El Omri, A Latiri, A Khelif, A Saad, S Ben Ahmed, E Bouajina, K Ben Haj Slama, L Zakraoui, R Hajri, M Laatar, M Ben Dridi, K Bouslama, M Abdallah, S M'rad, S Hamzaoui, I Ksontini, A Abdelkefi, T Ben Othman, L Torjman, S Ladeb, A Lakhal, A Ben Abdeladhim, H Ksouri, A Ben Hassen, A Hafsia, Z Belhadj, L Aissaoui, R Jeddi, R Ben Lakhal, B Meddeb, H Ben Abid, N Ben Romdhane, H Houmene, S Sellami, M Elleuch, C Ben Hadj Yahia, R Zouari, L Chaabouni, M Kchir, S Turki, K Ben Abdelghenni, R Goucha, A Kheder, H Ben Maiz, L Ben Hassine, N Khalfallah, M Karoui, F Msadek, B Louzir, S Othmani, S Ktari, L Rokbani, K Boukef, M Maamar, H Slama, L Ben Hamed, F Jenhani, N Mojaat, F Ben Ayed, A Mezlini, S Khalfallah, H Boussen, B Aissaoui, K Dellagi, H Louzir, I Safra, M Ben Ahmed, Y Galaï, A Amouri, S Guermazi, M Hsairi
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).
Trial registration: ClinicalTrials.gov NCT00207805.
Source: PubMed