SEATTLE--French researchers have recently concluded a study of multiple myeloma in which high-dose chemotherapy combined with autologous bone marrow transplantation (HDC/ABMT) resulted in a significant improvement in response rate and overall survival, compared with conventional chemotherapy.
Michel Attal, MD, PhD, head of the Bone Marrow Transplantation Unit, Purpan Hospital, Toulouse, presented the study results at the American Society of Hematology's 37th Annual Meeting.
Dr. Attal said that conventional chemotherapy for multiple myeloma has proved disappointing, with a median overall survival rate of only 2 to 3 years and few, if any, complete remissions.
To improve these results, a high-dose chemotherapy regimen using melphalan(Drug information on melphalan) (Alkeran) was developed for the treatment of aggressive multiple myeloma, and has been anecdotally reported to induce an improved response, including some complete remissions, in patients refractory to conventional dosages. This improved response was achieved at the expense of serious myelotoxicity, but use of ABMT has reduced this toxicity.
A direct comparison of this method with that of conventional treatment modalities has not previously been possible, due to patient selection bias (including young age and normal renal function), Dr. Attal said. The 5-year prospective trial, conducted by the Intergroupe Français du Myelome (IFM 90) in Toulouse, was designed to remove this selection bias.
At diagnosis, 200 patients under age 65 with intermediate or high tumor mass (stage II/III DS), previously untreated multiple myeloma were randomized to receive either a conventional chemotherapeutic regimen of VMCP/BVAP or high-dose therapy, consisting of melphalan (140 mg/m²) and total body irradiation, supported with unpurged autologous bone marrow, collected after two cycles of VMCP/BVAP. Maintenance with alpha-interferon was used in both arms.
The response rate was significantly better in the high-dose arm (22% complete response) than in the conventional arm (5%) (P less than .001). For the category of "very good partial response" (ie, greater than 90% response), the numbers were 16% vs 9%, respectively.