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/m2), the most effective agent for MM, and G-CSF (10 microg/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 x 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.
authors.affiliation: Hematology Service, Division of Hematologic Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
authors.forename: S
authors.initials: S
authors.lastname: Gupta
authors.forename: P
authors.initials: P
authors.lastname: Zhou
authors.forename: H
authors.initials: H
authors.lastname: Hassoun
authors.forename: T
authors.initials: T
authors.lastname: Kewalramani
authors.forename: L
authors.initials: L
authors.lastname: Reich
authors.forename: S
authors.initials: S
authors.lastname: Costello
authors.forename: L
authors.initials: L
authors.lastname: Drake
authors.forename: V
authors.initials: V
authors.lastname: Klimek
authors.forename: M
authors.initials: M
authors.lastname: Dhodapkar
authors.forename: J
authors.initials: J
authors.lastname: Teruya-Feldstein
authors.forename: C
authors.initials: C
authors.lastname: Hedvat
authors.forename: N
authors.initials: N
authors.lastname: Kalakonda
authors.forename: M
authors.initials: M
authors.lastname: Fleisher
authors.forename: D
authors.initials: D
authors.lastname: Filippa
authors.forename: J
authors.initials: J
authors.lastname: Qin
authors.forename: S D
authors.initials: SD
authors.lastname: Nimer
authors.forename: R L
authors.initials: RL
authors.lastname: Comenzo
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods*; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D007937:Leukapheresis / Q000379:methods; D008297:Male; D008558:Melphalan / Q000008:administration & dosage* / Q000633:toxicity; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications / Q000628:therapy*; D009360:Neoplastic Cells, Circulating / Q000187:drug effects; D009503:Neutropenia; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D008558:Melphalan