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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01037517
First Posted: December 23, 2009
Last Update Posted: October 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. David Szwajcer, CancerCare Manitoba
  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
Intervention Model: Parallel Assignment
Masking: None (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 Dr. David Szwajcer, 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 ]

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 ]
  • To describe the kinetics of platelet and neutrophil recovery post ASCT in those treated and not treated with plerixafor [ Time Frame: After therapy ]
  • To examine the immune recovery at day 100 post ASCT in those treated and not treated with plerixafor [ Time Frame: After therapy ]
  • 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 ]

Enrollment: 52
Study Start Date: January 2010
Study Completion Date: August 2013
Primary Completion Date: August 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037517


Locations
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Sponsors and Collaborators
CancerCare Manitoba
  More Information

Additional Information:
Responsible Party: Dr. David Szwajcer, Hematologist/Oncologist, CancerCare Manitoba
ClinicalTrials.gov Identifier: NCT01037517     History of Changes
Other Study ID Numbers: CCM-002
First Submitted: December 18, 2009
First Posted: December 23, 2009
Last Update Posted: October 31, 2013
Last Verified: October 2013

Keywords provided by Dr. David Szwajcer, CancerCare Manitoba:
Myeloma
Multiple Myeloma or Lymphoma Patients undergoing
mobilization for the purpose of autologous stem cell collection

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
JM 3100
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents