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

Phase 2

Completed

• Conditions: Lymphoma; Multiple Myeloma
• Interventions: Drug: Plerixafor

• Registration Number: NCT01037517
• Lead Sponsor: CancerCare Manitoba

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-18
• Study First Submitted QC: 2009-12-22
• Study First Posted: 2009-12-23
• Study Start: 2010-01
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-30
• Last Update Posted: 2013-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Poor Mobilizers	Plerixafor	Poor Mobilizer are defined as patients who on Day -1 have a peripheral blood \[CD34\] ≤ 10 X106/L

Primary Outcome Measures

Name	Time	Method
To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected in one day. The anticipated proportion increase is from 30%-60%.	within 1-2 days after commencing therapy

Secondary Outcome Measures

Name	Time	Method
To examine the immune recovery at day 100 post ASCT in those treated and not treated with plerixafor	After therapy
To undertake a pharmacoeconomic evaluation to examine the impact of plerixafor on resource utilization in a population at risk for poor mobilization	After therapy
To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected on first mobilization attempt rather than requiring a second mobilization.	After therapy
To describe the kinetics of platelet and neutrophil recovery post ASCT in those treated and not treated with plerixafor	After therapy

Trial Locations

Locations (1)

CancerCare Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada