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Original Article
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Volume 335:91-97 July 11, 1996 Number 2
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A Prospective, Randomized Trial of Autologous Bone Marrow Transplantation and Chemotherapy in Multiple Myeloma
Michel Attal, M.D., Jean-Luc Harousseau, M.D., Anne-Marie Stoppa, M.D., Jean-Jacques Sotto, M.D., Jean-Gabriel Fuzibet, M.D., Jean-François Rossi, M.D., Philippe Casassus, M.D., Hervé Maisonneuve, M.D., Thierry Facon, M.D., Norbert Ifrah, M.D., Catherine Payen, M.D., Régis Bataille, M.D., for The Intergroupe Français du Myélome

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ABSTRACT

Background The median survival of patients with myeloma after conventional chemotherapy is three years or less. Promising results have been reported with high-dose therapy supported by autologous bone marrow transplantation. We conducted a randomized study comparing conventional chemotherapy and high-dose therapy.

Methods Two hundred previously untreated patients under the age of 65 years who had myeloma were randomly assigned at the time of diagnosis to receive either conventional chemotherapy or high-dose therapy and autologous bone marrow transplantation.

Results The response rate among the patients who received high-dose therapy was 81 percent (including complete responses in 22 percent and very good partial responses in 16 percent), whereas it was 57 percent (complete responses in 5 percent and very good partial responses in 9 percent) in the group treated with conventional chemotherapy (P<0.001). The probability of event-free survival for five years was 28 percent in the high-dose group and 10 percent in the conventional-dose group (P = 0.01); the overall estimated rate of survival for five years was 52 percent in the high-dose group and 12 percent in the conventional-dose group (P = 0.03). Treatment-related mortality was similar in the two groups.

Conclusions High-dose therapy combined with transplantation improves the response rate, event-free survival, and overall survival in patients with myeloma.


Source Information

From the Departments of Hematology and Biostatistics, Hôpital Purpan, Toulouse (M.A., C.P.); Hôtel Dieu, Nantes (J.-L.H., R.B.); Institut Paoli Calmettes, Marseilles (A.-M.S.); Hôpital Albert Michallon, Grenoble (J.-J.S.); Hôpital de Cimiez, Nice (J.-G.F.); Hôpital Lapeyronie, Montpellier (J.-F.R.); Hôpital Avicenne, Bobigny (P.C.); Hôpital de la Roche sur Yon, la Roche sur Yon (H.M.); Hôpital C. Huriez, Lille (T.F.); and the Centre Hospitalier et Universitaire d'Angers, Angers (N.I.) — all in France.

Address reprint requests to Dr. Attal at the Service d'Hématologie, Hôpital Purpan, Place du Docteur-Baylac, 31059 Toulouse, France.

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Related Letters:

High-Dose Chemotherapy in Multiple Myeloma
Atkins C. D., Oivanen T. M., Palva I. P., Attal M., Harousseau J.-L., Bataille R.
Extract | Full Text  
N Engl J Med 1996; 335:1844-1845, Dec 12, 1996. Correspondence

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