Clinical trials

MOZOBL06877

02/23/2015

DETECTION OF POOR MOBILIZER (PM) IN MULTIPLE MYELOMA (MM) PATIENTS: PROSPECTIVE PRODUCT REGISTRY

In this study patients eligible for autologous stem-cell transplantation are enrolled and undergo mobilization therapy following the local procedures. Patients who fail the first mobilization therapy (cyclophosphamide and G-CSF) receive plerixafor as mobilizing agent.

OBJECTIVES:

Primary Objective:

To evaluate poor mobilizer rate in newly diagnosed MM patients who are treated with cyclophosphamide and G-CSF and plerixafor on demand for mobilization

Secondary Objective:

To identify the role of plerixafor in the collection of CD34+ cells in PM;
To evaluate the fold increase number of peripheral blood (PB) CD34+ cells in a pre-specified time period increase after plerixafor administration;
To evaluate the factors or combination of factors predisposing to a suboptimal mobilization.

STUDY POPULATION:

Newly diagnosed MM patients who are eligible for AutoSCT and who are mobilised in accordance with center policy and SmPC of plerixafor.

STUDY DRUGS:

Plerixafor

TOTAL SAMPLE SIZE: 300

ACCRUAL TIME: 36 months

STUDY DURATION: 37 months

Study type: Observational
Enrollment: Closed
Study phase:
Phase 1
Phase 2
Phase 3
Sponsor: HOVON Foundation