Trial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for Poor Stem Cell Mobilization

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Poor mobilization of hematopoietic progenitors needed to support autologous transplantation is a serious clinical problem. We are investigating the role of plerixafor administered in an at risk population to augment successful stem cell collection.

OBJECTIVES

To determine if plerixafor when administered on the day prior to planned autologous collection on first mobilization attempt in those with a peripheral blood CD34 ≤ 10X106/L will:

• increase the number of patients successfully collected in one day

• increase the number of patients successfully mobilized on first collection attempt

• is cost neutral within a Canadian setting

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CancerCare Manitoba
• Treatments: JM 3100; Plerixafor

Criteria

Inclusion Criteria:

1. Participants must be 18 years of age or older

2. Patients must be able to provide written consent

3. Participants must have a diagnosis of lymphoma or multiple myeloma and be undergoing autologous stem cell mobilization for the purposes of ASCT

4. Females of child bearing age will be asked to use an approved form of contraception

Exclusion Criteria:

1. Patients who are pregnant or breastfeeding

2. Patients whose creatinine ≥ 250 μM

3. Serum AST, ALT or total bilirubin >5X upper limit of normal

4. Acute infection