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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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CLINICAL TRIALS AND OBSERVATIONS

Maintenance therapy with thalidomide improves survival in patients with multiple myeloma

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, Thierry Facon, for the Inter-Groupe Francophone du Myélome (IFM)

From the Department of Hematology, Hôpital Purpan, Toulouse, France; the Department of Biostatistics, Hôpital Purpan, Toulouse, France; the Hôtel Dieu, Nantes, France; the Centre Hospitalier Universitaire, Lausanne, Switzerland; the Cliniques Universitaires de Mont-Godinne, Yvoir, Belgium; the Centre Hospitalier Brabois, Nancy, France; the Hôpital Bretonneau, Tours, France; the Hôpital C. Huriez, Lille, France; the Institut Gustave Roussy, Villejuif, France; the Hôpital St-Antoine, Paris, France; the Hôpital Albert Michallon, Grenoble, France; the Hôpital Edouard Herriot, Lyon, France; the Centre Hospitalier la Mileterie, Poitiers, France; the Hôpital Jean Minjoz, Besançon, France; the Hôpital A. Morvan, Brest, France; the Hôpital Haut-Lévèque, Bordeaux Pessac, France; the Centre Henri Becquerel, Rouen, France; the Centre Hospitalier Le Bocage, Dijon, France; and the Hôpital Sud, Rennes, France.

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 younger than age 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 = .03). The 3-year postrandomization probability of event-free survival was 36% in arm A, 37% in arm B, and 52% in arm C (P < .009). The 4-year postdiagnosis probability of survival was 77% in arm A, 74% in arm B, and 87% in arm C (P < .04). The proportion of patients who had skeletal events was 24% in arm A, 21% in arm B, and 18% in arm C (P = .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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