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OpenTrials
Completed

NCT Number: NCT01037517

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

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

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

plerixafor

Drug

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 names: Mozobil®

Observation: Nonintervention

Other

Nonintervention group, no drug will be given, observation only

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

CancerCare Manitoba

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 23, 2009
Registry last updated
Oct 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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