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

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ClinicalTrials.gov Identifier: NCT01037517
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : October 31, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. David Szwajcer, 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

Condition or disease Intervention/treatment Phase
Multiple Myeloma Lymphoma Drug: Plerixafor Other: Observation: Nonintervention Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
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
Study Start Date : January 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Plerixafor
U.S. FDA Resources

Arm Intervention/treatment
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®



Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. To describe the kinetics of platelet and neutrophil recovery post ASCT in those treated and not treated with plerixafor [ Time Frame: After therapy ]
  3. To examine the immune recovery at day 100 post ASCT in those treated and not treated with plerixafor [ Time Frame: After therapy ]
  4. 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 ]


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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

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

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 Posted: December 23, 2009    Key Record Dates
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