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Phase I/II study of tandem high-dose chemotherapy with autologous peripheral blood stem cell transplantation for advanced multiple myeloma.

Abstract
The efficacy and safety of high-dose chemotherapy with tandem autologous peripheral blood stem cell transplantation (auto-PBSCT) were evaluated in a multicenter clinical study of patients with advanced multiple myeloma. Eligible patients (n = 40) were consecutively enrolled in the phase I/II study and received 2-4 cycles of vincristine-adriamycin-dexamethasone regimen. The responding patients underwent PBSC harvesting following high-dose cyclophosphamide and filgrastim administration. The first auto-PBSCT (n = 32) following high-dose melphalan (200 mg/m(2)) was performed within 2 months of PBSC harvesting; the second auto-PBSCT (n = 28) was scheduled 3-6 months later. Treatment-related mortality was 2.5% (n = 1) throughout the protocol. Grade 4 nonhematologic toxicity occurred in 12.5 and 14.3% of the first and second auto-PBSCT patients, respectively. All but one patient (who died) achieved hematopoietic recovery. For the 28 patients completing the second auto-PBSCT, the results were favorable with a response rate of 65% (complete response rate = 27.5%, n = 11); the five-year progression-free survival and overall survival were 20.3 and 66.5%, respectively. In conclusion, high-dose chemotherapy with tandem auto-PBSCT is feasible and safe with a favorable response rate in treating advanced multiple myeloma in Japan.
AuthorsKazutaka Sunami, Katsuji Shinagawa, Morio Sawamura, Akira Sakai, Yoshio Saburi, Yutaka Imamura, Ishikazu Mizuno, Shigehisa Tamaki, Tomohiko Kamimura, Hiroyuki Tsuda, Hisashi Gondo, Norihiko Hino, Chihiro Shimazaki, Akira Miyata, Fumihito Tajima, Yoshinobu Takemoto, Akiyoshi Miwa, Takaaki Chou, Mine Harada
JournalInternational journal of hematology (Int J Hematol) Vol. 90 Issue 5 Pg. 635-642 (Dec 2009) ISSN: 1865-3774 [Electronic] Japan
PMID19936876 (Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study)
Chemical References
  • Vincristine
  • Dexamethasone
  • Doxorubicin
Topics
  • Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
  • Combined Modality Therapy (methods, mortality)
  • Dexamethasone (administration & dosage)
  • Doxorubicin (administration & dosage)
  • Humans
  • Multiple Myeloma (mortality, therapy)
  • Peripheral Blood Stem Cell Transplantation (methods)
  • Survival Rate
  • Transplantation, Autologous
  • Treatment Outcome
  • Vincristine (administration & dosage)

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