Bortezomib and high-dose melphalan as conditioning regimen before autologous stem cell transplantation in patients with de novo multiple myeloma: a phase 2 study of the Intergroupe Francophone du Myelome (IFM)

作者：Roussel Murielle^*; Moreau Philippe; Huynh Anne; Mary Jean Yves; Danho Clotaire; Caillot Denis; Hulin Cyrille; Fruchart Christophe; Marit Gerald; Pegourie Brigitte; Lenain Pascal; Araujo Carla; Kolb Brigitte; Randriamalala Edouard; Royer Bruno; Stoppa Anne Marie; Dib Mammoun; Dorvaux Veronique; Garderet Laurent; Mathiot Claire; Avet Loiseau Herve; Harousseau Jean Luc; Attal Michel

来源：Blood, 2010, 115(1): 32-37.

DOI：10.1182/blood-2009-06-229658

Autologous stem cell transplantation (ASCT) is recommended for younger patients with newly diagnosed multiple myeloma. Achieving complete response (CR) or at least very good partial response (VGPR) is a major prognostic factor for survival with 20% to 30% of patients achieving CR after ASCT. Bortezomib has shown synergistic effects with melphalan and no prolonged hematologic toxicity. In this Intergroupe Francophone du Myelome (IFM) phase 2 study, 54 untreated patients were enrolled between July and December 2007 to receive bortezomib (1 mg/m(2) x 4) and melphalan (200 mg/m2) as conditioning regimen (Bor-HDM). Overall, 70% of patients achieved at least VGPR, including 17 patients with CR (32%) after ASCT. No toxic deaths were observed. Bortezomib did not increase hematologic toxicity. Only 1 grade 3 to 4 peripheral neuropathy was reported. A matched control analysis was conducted comparing our cohort with patients from the IFM 2005-01 trial (HDM alone). Patients were matched for response to induction therapy and type of induction: CR was higher in the Bor-HDM group (35% vs 11%; P = .001), regardless of induction therapy. These results suggest that Bor-HDM is a safe and promising conditioning regimen. Randomized studies are needed to assess whether this conditioning regimen is superior to HDM alone. This trial was registered at www.clinicaltrials.gov as NCT00642395. (Blood. 2010;115:32-37)

• 出版日期2010-1-7
• 单位河南工业大学