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" |