Back to resultsTrial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for Poor Stem Cell Mobilization
Primary Purpose
Multiple Myeloma, Lymphoma
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Plerixafor
Observation: Nonintervention
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Myeloma, Multiple Myeloma or Lymphoma Patients undergoing, mobilization for the purpose of autologous stem cell collection
Eligibility Criteria
Inclusion Criteria:
- Participants must be 18 years of age or older
- Patients must be able to provide written consent
- Participants must have a diagnosis of lymphoma or multiple myeloma and be undergoing autologous stem cell mobilization for the purposes of ASCT
- Females of child bearing age will be asked to use an approved form of contraception
Exclusion Criteria:
- Patients who are pregnant or breastfeeding
- Patients whose creatinine ≥ 250 μM
- Serum AST, ALT or total bilirubin >5X upper limit of normal
- Acute infection
Sites / Locations
- CancerCare Manitoba
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Successful Mobilizers
Poor Mobilizers
Arm Description
Successful Mobilizers are defined as having a peripheral blood CD34 > 10X106/L.
Poor Mobilizer are defined as patients who on Day -1 have a peripheral blood [CD34] ≤ 10 X106/L
Outcomes
Primary Outcome Measures
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%.
Secondary Outcome Measures
To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected on first mobilization attempt rather than requiring a second mobilization.
To describe the kinetics of platelet and neutrophil recovery post ASCT in those treated and not treated with plerixafor
To examine the immune recovery at day 100 post ASCT in those treated and not treated with plerixafor
To undertake a pharmacoeconomic evaluation to examine the impact of plerixafor on resource utilization in a population at risk for poor mobilization
Full Information
NCT ID
NCT01037517
First Posted
December 18, 2009
Last Updated
October 30, 2013
Sponsor
CancerCare Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT01037517
Brief Title
Trial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for Poor Stem Cell Mobilization
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CancerCare Manitoba
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Lymphoma
Keywords
Myeloma, Multiple Myeloma or Lymphoma Patients undergoing, mobilization for the purpose of autologous stem cell collection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Successful Mobilizers
Arm Type
Active Comparator
Arm Description
Successful Mobilizers are defined as having a peripheral blood CD34 > 10X106/L.
Arm Title
Poor Mobilizers
Arm Type
Experimental
Arm Description
Poor Mobilizer are defined as patients who on Day -1 have a peripheral blood [CD34] ≤ 10 X106/L
Intervention Type
Drug
Intervention Name(s)
Plerixafor
Other Intervention Name(s)
Mozobil®
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Observation: Nonintervention
Intervention Description
Nonintervention group, no drug will be given, observation only
Primary Outcome Measure Information:
Title
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%.
Time Frame
within 1-2 days after commencing therapy
Secondary Outcome Measure Information:
Title
To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected on first mobilization attempt rather than requiring a second mobilization.
Time Frame
After therapy
Title
To describe the kinetics of platelet and neutrophil recovery post ASCT in those treated and not treated with plerixafor
Time Frame
After therapy
Title
To examine the immune recovery at day 100 post ASCT in those treated and not treated with plerixafor
Time Frame
After therapy
Title
To undertake a pharmacoeconomic evaluation to examine the impact of plerixafor on resource utilization in a population at risk for poor mobilization
Time Frame
After therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants must be 18 years of age or older
Patients must be able to provide written consent
Participants must have a diagnosis of lymphoma or multiple myeloma and be undergoing autologous stem cell mobilization for the purposes of ASCT
Females of child bearing age will be asked to use an approved form of contraception
Exclusion Criteria:
Patients who are pregnant or breastfeeding
Patients whose creatinine ≥ 250 μM
Serum AST, ALT or total bilirubin >5X upper limit of normal
Acute infection
Facility Information:
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.cancercare.mb.ca
Description
Official CancerCare Manitoba Website
Learn more about this trial
Trial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for Poor Stem Cell Mobilization
We'll reach out to this number within 24 hrs