title: A randomized phase II study of stem cell mobilization with cyclophosphamide+G-CSF or G-CSF alone after lenalidomide-based induction in multiple myeloma.
abstract: The most common means of mobilizing autologous stem cells is G-CSF alone or combined with cyclophosphamide (CY) to obtain sufficient CD34+ cells for one to two transplants. There are few prospective, randomized studies investigating mobilization regimens in multiple myeloma (MM), especially after lenalidomide-based induction. We designed this prospective, randomized study to compare low-dose CY 2 g/m2 +G-CSF (arm A) and G-CSF alone (arm B) after lenalidomide-based up-front induction in MM. Of the 80 initially randomized patients, 69 patients were evaluable, 34 and 35 patients in arms A and B, respectively. The primary end point was the proportion of patients achieving a yield of ⩾3 × 10(6)/kg CD34+ cells with 1-2 aphereses, which was achieved in 94% and 77% in arms A and B, respectively (P=0.084). The median number of aphereses needed to reach the yield of ⩾3 × 10(6)/kg was lower in arm A than in arm B (1 vs. 2, P=0.035). Two patients needed plerixafor in arm A and five patients in arm B (P=0.428). Although CY-based mobilization was more effective, G-CSF alone was successful in a great majority of patients to reach the defined collection target after three cycles of lenalidomide-based induction.
authors.affiliation: Department of Medicine, Kuopio University Hospital, Kuopio, Finland.
authors.forename: R
authors.initials: R
authors.lastname: Silvennoinen
authors.affiliation: Cancer Center, Helsinki University Central Hospital, Helsinki, Finland.
authors.forename: P
authors.initials: P
authors.lastname: Anttila
authors.affiliation: Hematology-Oncology Unit, Oulu University Hospital, Oulu, Finland.
authors.forename: M
authors.initials: M
authors.lastname: Säily
authors.affiliation: Department of Clinical Chemistry and TYKSLAB, University of Turku and Turku University Central Hospital, Turku, Finland.
authors.forename: T
authors.initials: T
authors.lastname: Lundan
authors.affiliation: Cancer Center, Helsinki University Central Hospital, Helsinki, Finland.
authors.forename: J
authors.initials: J
authors.lastname: Heiskanen
authors.affiliation: Hematology-Oncology Unit, Oulu University Hospital, Oulu, Finland.
authors.forename: T M
authors.initials: TM
authors.lastname: Siitonen
authors.affiliation: Hematology-Oncology Unit, Oulu University Hospital, Oulu, Finland.
authors.forename: S
authors.initials: S
authors.lastname: Kakko
authors.affiliation: Hematology Unit, Turku University Central Hospital, Turku, Finland.
authors.forename: M
authors.initials: M
authors.lastname: Putkonen
authors.affiliation: Department of Medicine, Satakunta Central Hospital, Pori, Finland.
authors.forename: H
authors.initials: H
authors.lastname: Ollikainen
authors.affiliation: Hematology Unit, Tampere University Hospital, Tampere, Finland.
authors.forename: V
authors.initials: V
authors.lastname: Terävä
authors.affiliation: Department of Medicine, Mikkeli Central Hospital, Mikkeli, Finland.
authors.forename: A
authors.initials: A
authors.lastname: Kutila
authors.affiliation: Department of Medicine, Länsi-Pohja Central Hospital, Kemi, Finland.
authors.forename: K
authors.initials: K
authors.lastname: Launonen
authors.affiliation: Department of Medicine, Kymenlaakso Central Hospital, Kotka, Finland.
authors.forename: A
authors.initials: A
authors.lastname: Räsänen
authors.affiliation: Department of Medicine, Central Finland Central Hospital, Jyväskylä, Finland.
authors.forename: A
authors.initials: A
authors.lastname: Sikiö
authors.affiliation: Department of Medicine, Kanta-Häme Central Hospital, Hämeenlinna, Finland.
authors.forename: M
authors.initials: M
authors.lastname: Suominen
authors.affiliation: Department of Medicine, Kainuu Central Hospital, Kajaani, Finland.
authors.forename: P
authors.initials: P
authors.lastname: Bazia
authors.affiliation: Department of Medicine, Kainuu Central Hospital, Kajaani, Finland.
authors.forename: K
authors.initials: K
authors.lastname: Kananen
authors.affiliation: Science Services Center, Kuopio University Hospital, Kuopio, Finland.
authors.forename: T
authors.initials: T
authors.lastname: Selander
authors.affiliation: Department of Medicine, Kuopio University Hospital, Kuopio, Finland.
authors.forename: T
authors.initials: T
authors.lastname: Kuittinen
authors.affiliation: Hematology Unit, Turku University Central Hospital, Turku, Finland.|Department of Clinical Hematology, University of Turku, Turku, Finland.
authors.forename: K
authors.initials: K
authors.lastname: Remes
authors.affiliation: Department of Medicine, Kuopio University Hospital, Kuopio, Finland.
authors.forename: E
authors.initials: E
authors.lastname: Jantunen
mesh_terms: D000328:Adult; D000368:Aged; D064592:Autografts; D003520:Cyclophosphamide / Q000008:administration & dosage* / Q000009:adverse effects; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects; D019650:Hematopoietic Stem Cell Mobilization; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D060828:Induction Chemotherapy / Q000009:adverse effects / Q000379:methods; D000077269:Lenalidomide; D008875:Middle Aged; D009101:Multiple Myeloma; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D013792:Thalidomide; D003520:Cyclophosphamide; D000077269:Lenalidomide