Results of a phase I/II trial adding carmustine (300mg/m 2) to melphalan (200mg/m 2) in multiple myeloma patients undergoing autologous stem cell transplantation Journal Article


Authors: Comenzo, R. L.; Hassoun, H.; Kewalramani, T.; Klimek, V.; Dhodapkar, M.; Reich, L.; Teruya-Feldstein, J.; Fleisher, M.; Filippa, D.; Nimer, S. D.
Article Title: Results of a phase I/II trial adding carmustine (300mg/m 2) to melphalan (200mg/m 2) in multiple myeloma patients undergoing autologous stem cell transplantation
Abstract: Autologous stem cell transplantation (SCT) with high-dose melphalan (HDM, 200mg/m 2) is the most effective therapy for multiple myeloma. To determine the feasibility of combining carmustine (300mg/m 2) with HDM, we enrolled 49 patients with previously treated Durie -Salmon stage II/III myeloma (32M/17W, median age 53) on a phase I/II trial involving escalating doses of melphalan (160, 180, 200mg/m 2). The median β2-microglobulin was 2.5 (0 -9.3); marrow karyotypes were normal in 88%. The phase I dose-limiting toxicity was >grade 2 pulmonary toxicity 2 months post-SCT. Other endpoints were response rate and progression-free survival (PFS). HDM was safely escalated to 200mg/m 2; treatment-related mortality was 2% and >grade 2 pulmonary toxicity 10%. The complete (CR) and near complete (nCR) response rate was 49%. With a median post-SCT follow-up of 2.9 years, the PFS and overall survival (OS) post-SCT were 2.3 and 4.7 years. PFS for those with CR or nCR was 3.1 years while for those with stable disease (SD) it was 1.3 years (P =0.06). We conclude that carmustine can be combined with HDM for myeloma with minimal pulmonary toxicity and a high response rate. © 2006 Nature Publishing Group. All rights reserved.
Keywords: adult; cancer survival; clinical article; controlled study; treatment outcome; aged; middle aged; survival analysis; prednisone; thalidomide; clinical trial; doxorubicin; cancer growth; drug safety; combined modality therapy; follow up; follow-up studies; controlled clinical trial; lung toxicity; multiple myeloma; phase 2 clinical trial; bone marrow suppression; antineoplastic combined chemotherapy protocols; recurrence; cyclophosphamide; dexamethasone; melphalan; steroid; vincristine; autologous stem cell transplantation; dose-response relationship, drug; transplantation; cancer mortality; carmustine; hypoxia; drug fatality; feasibility study; antineoplastic agents, alkylating; stem cells; colon resection; sepsis; methylprednisolone; colon perforation; beta 2 microglobulin; gentamicin; phase 1 clinical trial; drug dose regimen; peripheral blood stem cell transplantation; karyotype; granulocyte colony stimulating factor; transplantation, autologous; myeloma; lung diseases; pulmonary; bronchiolitis obliterans organizing pneumonia
Journal Title: Leukemia
Volume: 20
Issue: 2
ISSN: 0887-6924
Publisher: Nature Publishing Group  
Date Published: 2006-02-01
Start Page: 345
End Page: 349
Language: English
DOI: 10.1038/sj.leu.2404003
PUBMED: 16319952
PROVIDER: scopus
DOI/URL:
Notes: --- - "Cited By (since 1996): 4" - "Export Date: 4 June 2012" - "CODEN: LEUKE" - "Source: Scopus"
Altmetric Score
MSK Authors
  1. Virginia Klimek
    109 Klimek
  2. Julie T Feldstein
    288 Feldstein
  3. Raymond L Comenzo
    112 Comenzo
  4. Hani Hassoun
    149 Hassoun
  5. Stephen D Nimer
    345 Nimer
  6. Martin Fleisher
    241 Fleisher
  7. Lilian M Reich
    77 Reich
  8. Daniel A Filippa
    102 Filippa