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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037517
• Other study ID #: CCM-002
• Status: Completed
• Phase: Phase 2
• First received: December 18, 2009
• Last updated: October 30, 2013
• Start date: January 2010
• Est. completion date: August 2013

Study information

• Verified date: October 2013
• Source: CancerCare Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Plerixafor
Plerixafor will be administered at 23:00 of Day -1 to experimental subjects at a dose of 240 mcg/kg subcutaneously, and possibly repeated the following day

Other:
• Observation: Nonintervention
Nonintervention group, no drug will be given, observation only

Locations

Country	Name	City	State
Canada	CancerCare Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
CancerCare Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	To describe the kinetics of platelet and neutrophil recovery post ASCT in those treated and not treated with plerixafor		After therapy	No
Secondary	To examine the immune recovery at day 100 post ASCT in those treated and not treated with plerixafor		After therapy	No
Secondary	To undertake a pharmacoeconomic evaluation to examine the impact of plerixafor on resource utilization in a population at risk for poor mobilization		After therapy	No

External Links

•   Official CancerCare Manitoba Website