Stem cell mobilization with mozobil (plerixafor) in patients with multiple myeloma.
Conditions
Interventions
Trade Name: Mozobil
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Plerixafor
CAS Number: 110078-46-1
Other descriptive name: PLERIXAFOR
Concentration unit: mg/ml mil
Sponsors
Medical University Vienna, Dept. f. Transfusion Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate efficacy of plerixafor in patients with multiple myeloma in comparison to G-CSF alone for stem cell mobilization, as measured by stem cell harvest results sufficient for tandem-transplantation in only one collection.;Secondary Objective: To assess safety and tolerability of plerixafor in patients with multiple myeloma To assess effect of plerixafor on collection efficiency (CE1 and CE2) To assess differences in composition of stem cell grafts between patients with and without plerixafor treatment To assess differences in hematopoietic recovery, sustained engraftment an immunologic recovery after autologous transplantation ;Primary end point(s): Percentage of patients who achieve =6.0x10E6 CD34+ cells/kg in 1 apheresis for a planned double autologous HSCT;Timepoint(s) of evaluation of this end point: On the day of apheresis after end of stem cell collection (=one day after administration of the IMP). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage of patients who achieve 9.0x10E6 CD34+ cells/kg in 1 apheresis for three autologous HSCTs. Documentation of side-effects of plerixafor. Composition of leukapheresis product (all analysis performed at the CCRI Vienna). Collection efficiency (CE1 and CE2). Haematopoietic engraftment defined as absolute neutrophil counts above 0.5x10E9/L and platelet counts above 20x10E9/L without further transfusion requirements for first and second HSCT. Blood and differential counts at day 15, 28 and 3 and 6 months after HSCT (onsite). Assessment of immune reconstitution by analysis of CD3+, CD4+ and CD8+ cells and their cellular subsets, NK, DC, and B-cells in PB by flow cytometry at day 15, 28, and 3 and 6 months after HSCT. ;Timepoint(s) of evaluation of this end point: On the day of apheresis after end of stem cell collection and on day 15, 28 and 3 and 6 months after autologous transplantation. | — |
Countries
Austria
Contacts
Public ContactOffice
Medical University Vienna, Dept. f. Transfusion Medicine
Outcome results
None listed