Trial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for Poor Stem Cell Mobilization
This study is currently recruiting participants.
Verified February 2012 by CancerCare Manitoba
Sponsor:
CancerCare Manitoba
Information provided by (Responsible Party):
Dr. David Szwajcer, CancerCare Manitoba
ClinicalTrials.gov Identifier:
NCT01037517
First received: December 18, 2009
Last updated: February 10, 2012
Last verified: February 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma Lymphoma |
Drug: Plerixafor Other: Observation: Nonintervention |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by CancerCare Manitoba:
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%. [ Time Frame: within 1-2 days after commencing therapy ] [ Designated as safety issue: No ]
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. [ Time Frame: After therapy ] [ Designated as safety issue: No ]
- To describe the kinetics of platelet and neutrophil recovery post ASCT in those treated and not treated with plerixafor [ Time Frame: After therapy ] [ Designated as safety issue: No ]
- To examine the immune recovery at day 100 post ASCT in those treated and not treated with plerixafor [ Time Frame: After therapy ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Successful Mobilizers
Successful Mobilizers are defined as having a peripheral blood CD34 > 10X106/L.
|
Other: Observation: Nonintervention
Nonintervention group, no drug will be given, observation only
|
|
Experimental: Poor Mobilizers
Poor Mobilizer are defined as patients who on Day -1 have a peripheral blood [CD34] ≤ 10 X106/L
|
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 Name: Mozobil®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037517
Locations
| Canada, Manitoba | |
| CancerCare Manitoba | Recruiting |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Contact: Amber Delisle-Corps, HRT, CCRP 204-787-1596 amber.delislecorps@cancercare.mb.ca | |
| Contact: Kathryn Dyck, BA, CCRP 204-787-2127 Kathryn.Dyck@cancercare.mb.ca | |
| Principal Investigator: David Szwajcer, MD | |
| Principal Investigator: Donna Wall, MD | |
| Sub-Investigator: Matthew Seftel, MD | |
| Sub-Investigator: Morel Rubinger, MD | |
| Sub-Investigator: Rajat Kumar, MD | |
| Sub-Investigator: Vi Dao, MD | |
| Sub-Investigator: Ade Olujohunbe, MD | |
| Sub-Investigator: Kristjan Paulson, MD | |
Sponsors and Collaborators
CancerCare Manitoba
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. David Szwajcer, Hematologist/Oncologist, CancerCare Manitoba |
| ClinicalTrials.gov Identifier: | NCT01037517 History of Changes |
| Other Study ID Numbers: | CCM-002 |
| Study First Received: | December 18, 2009 |
| Last Updated: | February 10, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by CancerCare Manitoba:
|
Myeloma Multiple Myeloma or Lymphoma Patients undergoing mobilization for the purpose of autologous stem cell collection |
Additional relevant MeSH terms:
|
Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders JM 3100 Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013