Plerixafor MM02 - Plerixafor plus G-CSF after chemotherapy for the mobilization of Peripheral Blood Stem Cells (PBSCs) in Multiple Myeloma (MM) patients undergoing Autologous Stem Cell Transplantation (ASCT)

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 个研究点开始时间: 2012年3月5日最近更新: 2014年2月24日

适应症

试验速览

暂无简介。

•MM patients eligible and planned for ASCT according to Istitutional guidelines
•Age > 18 years
•Written informed consent
•Performance Status = 70% (Karnofsky) or = 2 (WHO).
•White blood cell (WBC) count = 2.5 x 109 /L
•Absolute neutrophil count (ANC) = 1.5 x 109 /L
•Platelet count = 100 x 109 /L
•Serum creatinine at time of enrollment = 2.0 mg/dL
•Aspartate aminotransferase/serum glutamnic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamnic pyruvic transaminase (ALT/SGPT), and total bilirubin at time of enrollment < 2.5 x upper limit of normal (ULN)
•Adequate cardiac, renal and pulmonary function to undergo apheresis and transplantation
•All patients must agree to use highly effective method of contraception while on study treatment and for at least 3 months following plerixafor treatment (including both female patients of child-bearing potential and male patients with partners of child-bearing potential).
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•History of any acute or chronic myelogenous leukemia
•HIV positivity; active Hepatitis B or Hepatitis C
•Intercurrent organ damage or medical problems that would interfere with therapy.
•Pregnant or nursing females.
•Concurrent uncontrolled infection.
•Previously received investigation therapy within 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilization phase
•Treated with G-CSF or other cytokine within 14 days prior to the first dose of G-CSF for mobilization

发起方

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI