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Blood, 15 November 2006, Vol. 108, No. 10, pp. 3289-3294.
Prepublished online as a Blood First Edition Paper on July 27, 2006; DOI 10.1182/blood-2006-05-022962.


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Submitted May 25, 2006
Accepted July 6, 2006

Maintenance therapy with thalidomide improves survival in multiple myeloma patients

Michel Attal*, Jean-Luc Harousseau, Serge Leyvraz, Chantal Doyen, Cyrille Hulin, Lofti Benboubker, Ibrahim Yakoub Agha, Jean-Henri Bourhis, Laurent Garderet, Brigitte Pegourie, Charles Dumontet, Marc Renaud, Laurent Voillat, Christian Berthou, Gerald Marit, Mathieu Monconduit, Denis Caillot, Bernard Grobois, Herve Avet-Loiseau, Philippe Moreau, and Thierry Facon

hopital purpan, Toulouse
Hotel Dieu, Nantes
centre hospitalier universitaire, Lausanne
cliniques universitaires de Mont-Godinne, Yvoir
centre hospitalier du Brabois, Nancy
hopital Bretonneau, Tours
hopital Huriez, Lille
institut Gustave Roussy, villejuif
hopital Saint-antoine, Paris
hopital albert Michallon, Grenoble
hopital edouard Herriot, Lyon
centre hospitalier la Mileterie, Poitiers
hopital jean Minjoz, Besancon
Hopital Morvan, Brest
hopital Haut-Leveque, Bordeaux
Centre henri Becquerel, Rouen
centre hospitalier Le Bocage, Dijon
hopital Sud, Rennes

* Corresponding author; email: attal.m{at}chu-toulouse.fr.

Newer chemotherapeutic protocols as well as high dose chemotherapy have increased the response rate in myeloma. However, these treatments are not curative. Effective maintenance strategies are now required to prolong the duration of response. We conducted a randomized trial of maintenance treatment with thalidomide and pamidronate. Two months after high dose therapy, 597 patients under the age of 65 years were randomly assigned to receive no maintenance (arm A), pamidronate (arm B), or pamidronate plus thalidomide (arm C). A complete or very good partial response was achieved by 55% of patients in arm A, 57% in arm B, and 67% in arm C (P=0.03). The 3-year post-randomization probability of event-free-survival was 36% in arm A, 37% in arm B, and 52% in arm C (P<0.009). The 4-year post-diagnosis probability of survival was 77% in arm A, 74% in arm B, and 87% in arm C (P<0.04). The proportion of patients who had skeletal events was 24% in arm A, 21% in arm B, and 18% in arm C (P=0.4). Thalidomide is an effective maintenance therapy in patients with multiple myeloma. Maintenance treatment with pamidronate does not decrease the incidence of bone events.


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