scholarly journals Prophylactic antibiotics for the prevention of neutropenic fever in patients undergoing autologous stem-cell transplantation: Results of a single institution, randomized phase 2 trial

2010 ◽  
Vol 85 (11) ◽  
pp. 863-867 ◽  
Author(s):  
Evangelos Eleutherakis-Papaiakovou ◽  
Evangelos Kostis ◽  
Magda Migkou ◽  
Dimitrios Christoulas ◽  
Evangelos Terpos ◽  
...  
Keyword(s):  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Prophylactic Antibiotics ◽  
Neutropenic Fever ◽  
Phase 2 ◽  
Single Institution ◽  
Phase 2 Trial ◽  
Randomized Phase 2

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 Myélome (IFM)

Blood ◽  
2010 ◽  
Vol 115 (1) ◽  
pp. 32-37 ◽  
Author(s):  
Murielle Roussel ◽  
Philippe Moreau ◽  
Anne Huynh ◽  
Jean-Yves Mary ◽  
Clotaire Danho ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Induction Therapy ◽  
Conditioning Regimen ◽  
Hematologic Toxicity ◽  
Phase 2 ◽  
Phase 2 Study

Abstract 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 Myélome (IFM) phase 2 study, 54 untreated patients were enrolled between July and December 2007 to receive bortezomib (1 mg/m2 × 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.

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