Plerixafor for stem cell mobilization in patients with Multiple Myeloma to optimize collection results

Phase 1

Conditions: Stem cell mobilization with mozobil (plerixafor) in patients with multiple myeloma.
Therapeutic area: Body processes [G] - Cell Physiological Phenomena [G04]

Registration Number: EUCTR2016-004122-41-AT

Lead Sponsor: Medical University Vienna, Dept. f. Transfusion Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>To assess effect of plerixafor on collection efficiency (CE1 and CE2)<br>To assess differences in composition of stem cell grafts between patients with and without plerixafor treatment<br>To assess differences in hematopoietic recovery, sustained engraftment an immunologic recovery after autologous transplantation<br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): Percentage of patients who achieve 9.0x10E6 CD34+ cells/kg in 1 apheresis for three autologous HSCTs.<br>Documentation of side-effects of plerixafor.<br>Composition of leukapheresis product (all analysis performed at the CCRI Vienna).<br>Collection efficiency (CE1 and CE2).<br>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.<br>Blood and differential counts at day 15, 28 and 3 and 6 months after HSCT (onsite).<br>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.<br>;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.