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

CancerCare Manitoba

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma; Lymphoma

Treatments: Drug: Plerixafor; Other: Observation: Nonintervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01037517

CCM-002

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Successful Mobilizers

Active Comparator group

Description:

Successful Mobilizers are defined as having a peripheral blood CD34 > 10X106/L.

Treatment:

Other: Observation: Nonintervention

Poor Mobilizers

Experimental group

Description:

Poor Mobilizer are defined as patients who on Day -1 have a peripheral blood [CD34] ≤ 10 X106/L

Treatment:

Drug: Plerixafor