Plerixafor for stem cell mobilization in patients with multiple myeloma who mobilize moderate to optimize collection results - a randomized, placebo-controlled, double-blind study - Plerixafor for moderate mobilizing myeloma patients

Medical University Vienna, Dept. f. Transfusion Medicine0 个研究点目标入组 120 人开始时间: 2017年3月2日最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•Age 18 to =75 years.
•Patients with MM in whom for at least two HSCTs cells have to be collected.
•After steady state mobilization with G-CSF alone: if =20/µL and =40/µL CD34+ cells in the PB on day 4 of G-CSF administration.
•Written informed consent.
•Female patients must be one of the following: postmenopausal, surgically incapable of bearing children, practicing an acceptable method of birth control (effective contraception) during treatment and up to a minimum of 3 months after the last dose of treatment. If a female patient is of childbearing potential, she must have a negative pregnancy test prior to study entry and in monthly intervals up to 3 months thereafter.
•Patients must be able and willing to comply with all study procedures.
•Renal impairment: dosage adjustment in patients with CrCl =50 mL/min is recommended. Patients with moderate and severe renal insufficiency (CrCl =50 mL/min) should have their dose of plerixafor reduced by one-third to 0.16 mg/kg.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•Acute and chronic leukemia.
•Myelodysplastic syndrome.
•Malignant lymphoma.
•Any active infection including Hepatitis B or C.
•HIV positivity.
•Fever>38.5C, or if >37 and <38.5, infection must be excluded.
•CBC abnormalities: ANC<0.75x109/L, Platelets<50x109/LCD34+ cell <20/µL or >40/µL in the PB on day 4 of G-CSF administration.
•Chemomobilization.
•Liver Function Test abnormalities: LFT>3x ULN (AST, ALT, T-Bil)
•History of clinically significant cardiac abnormality or arrhythmia
•Pregnant or breast feeding patients.
•Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of SmPC

发起方

Medical University Vienna, Dept. f. Transfusion Medicine