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Treosulfan/Fludarabine as conditioning regimen for allogeneic stem cell transplantation in multiple myeloma

Treosulfan/Fludarabine as conditioning regimen for allogeneic stem cell transplantation in multiple myeloma

Blood 102(11): 711a, November 16

While autologous stem cell transplantation (PBSCT) is considered as standard approach to treat multiple myeloma (MM), it does not offer definite cure from the disease. Curative potential is ascribed to allogeneic PBSCT, however, this procedure is reported to be highly toxic whenever "classical" myeloablative regimens are used for conditioning. Therefore, toxicity-reduced regimens are needed which allow patients with MM to proceed to allogeneic PBSCT. Treosulfan (L-Threitol 1,4-Bismethanesulfonate), a bifunctional alkylating agent, has shown efficacy against a variety of malignancies. It exhibits myeloablative potential making it suitable as preparative drug for transplantation. We first assessed the feasibility of a fix dose of 3X10 g/m2 Treosulfan i.v. combined with 5X30 mg/m2 Fludarabine for conditioning. Then, we started a dose-escalating study with Treosulfan 3X10 g/m2, 3X12 g/m2, and 3X14 g/m2, combined with Fludarabine 5X30 mg/m2, respectively. Out of 86 patients (pts) with various hematological malignancies included into the two trials, 16 pts suffered from MM. Twelve pts had a matched-related donor, the other 4 pts had a matched-unrelated donor. At time of this analysis, 15 out of the 16 pts are evaluable with respect to relapse/progression rate, mortality rate and survival data. All of them (median age 52 years, range 48-61) were heavily pretreated including 9 pts who had undergone prior autologous PBSCT. Conditioning was well tolerated, and all pts engrafted. Three relapses occurred at day 172, day 256 and 470 after PBSCT, respectively, while median progression-free survival is not reached so far. Two deaths were reported. One was due to cardiac amyloidosis on day 62 after transplantation, the other was related to severe infection on day 713. Considering the relatively limited observation time, median overall survival is 223+ days (range 13-1008). In summary, the combination of Treosulfan and Fludarabine appears to be a suitable regimen to prepare pts with MM for allogeneic PBSCT. While the optimal Treosulfan dose is currently defined, this regimen showed a promising low toxicity profile and so far a low relapse/progression rate. It therefore may permit even heavily pretreated pts with MM to proceed to allogeneic PBSCT and to pursue the curative goal of treatment.

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Accession: 035985739

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