Hematopoietic stem cell mobilization with intravenous melphalan and G-CSF in patients with chemoresponsive multiple myeloma: Report of a phase II trial Journal Article

Authors: Gupta, S.; Zhou, P.; Hassoun, H.; Kewalramani, T.; Reich, L.; Costello, S.; Drake, L.; Klimek, V.; Dhodapkar, M.; Teruya-Feldstein, J.; Hedvat, C.; Kalakonda, N.; Fleisher, M.; Filippa, D.; Qin, J.; Nimer, S. D.; Comenzo, R. L.
Article Title: Hematopoietic stem cell mobilization with intravenous melphalan and G-CSF in patients with chemoresponsive multiple myeloma: Report of a phase II trial
Abstract: Multiple myeloma (MM) is an incurable hematologic malignancy for which autologous hematopoietic stem cell transplantation (HCT) is a standard therapy. The optimal method of stem cell mobilization is not defined. We evaluated intravenous melphalan (60 mg/m 2), the most effective agent for MM, and G-CSF (10 μg/kg/day) for mobilization. End points were safety, adequacy of CD34 + collections, MM response, and contamination of stem cell components (SCC). In total, 32 patients were mobilized. There were no deaths or significant bleeding episodes; 14 patients (44%) required hospitalization for neutropenic fever. Median days of grade 3 or 4 neutropenia or thrombocytopenia were 7 (2-20) and 8 (3-17). Median mobilization days, CD34 + cells/kg and total leukaphereses were 16 (12-30), 12.1 million (2.6-52.8), and 2 (1-5) respectively. Four patients (12.5 %) failed to achieve the target of 4 million CD34 + cells/kg in five leukaphereses. Reduction in myeloma was seen in 11 patients (34%) with 3 (9%) achieving complete response; 15 (47%) maintained prior responses. Estimated MM contamination per SCC (N=48) was 0.0009% (range 0-0.1) and 0.21 × 10 4 cells per kg (range 0-41.2). Increased contamination was associated with increased patient age. This strategy for mobilization is feasible, frequently requires hospitalization and transfusion, and controls disease in most patients. © 2005 Nature Publishing Group All rights reserved.
Keywords: adult; clinical article; controlled study; treatment outcome; aged; middle aged; treatment failure; human cell; prednisone; thalidomide; clinical trial; neutropenia; doxorubicin; cancer combination chemotherapy; drug efficacy; drug safety; cd34 antigen; chemoprophylaxis; controlled clinical trial; multiple myeloma; phase 2 clinical trial; anemia; bleeding; thrombocytopenia; cyclophosphamide; dexamethasone; melphalan; vincristine; hematopoietic stem cell transplantation; age factors; age; febrile neutropenia; fever; drug fatality; hospitalization; correlation analysis; disease severity; feasibility study; drug response; ciprofloxacin; blood transfusion; stem cell mobilization; cell count; methylprednisolone; disease duration; bacteremia; virus infection; cancer control; drug dose regimen; granulocyte colony stimulating factor; granulocyte colony-stimulating factor; hematopoietic stem cell mobilization; transplantation, autologous; congestive heart failure; fluconazole; contamination; frequency analysis; dose time effect relation; leukapheresis; cell composition; neoplasm circulating cells
Journal Title: Bone Marrow Transplantation
Volume: 35
Issue: 5
ISSN: 0268-3369
Publisher: Nature Publishing Group  
Date Published: 2005-03-01
Start Page: 441
End Page: 447
Language: English
DOI: 10.1038/sj.bmt.1704779
PUBMED: 15640822
PROVIDER: scopus
Notes: --- - "Cited By (since 1996): 15" - "Export Date: 24 October 2012" - "CODEN: BMTRE" - "Source: Scopus"
Altmetric Score
MSK Authors
  1. Virginia Klimek
    109 Klimek
  2. Cyrus Hedvat
    123 Hedvat
  3. Julie T Feldstein
    288 Feldstein
  4. Seema Gupta
    6 Gupta
  5. Jing Qin
    86 Qin
  6. Raymond L Comenzo
    112 Comenzo
  7. Ping Zhou
    43 Zhou
  8. Hani Hassoun
    149 Hassoun
  9. Stephen D Nimer
    345 Nimer
  10. Martin Fleisher
    242 Fleisher
  11. Lilian M Reich
    77 Reich
  12. Daniel A Filippa
    102 Filippa
  13. Lisa A Drake
    8 Drake