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

NCT ID: NCT01037517

Last Updated: 2013-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Multiple Myeloma Lymphoma

Keywords

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Myeloma Multiple Myeloma or Lymphoma Patients undergoing mobilization for the purpose of autologous stem cell collection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Successful Mobilizers

Successful Mobilizers are defined as having a peripheral blood CD34 \> 10X106/L.

Group Type ACTIVE_COMPARATOR

Observation: Nonintervention

Intervention Type OTHER

Nonintervention group, no drug will be given, observation only

Poor Mobilizers

Poor Mobilizer are defined as patients who on Day -1 have a peripheral blood \[CD34\] ≤ 10 X106/L

Group Type EXPERIMENTAL

Plerixafor

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Observation: Nonintervention

Nonintervention group, no drug will be given, observation only

Intervention Type OTHER

Other Intervention Names

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Mozobil®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CancerCare Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Dr. David Szwajcer

Hematologist/Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Related Links

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http://www.cancercare.mb.ca

Official CancerCare Manitoba Website

Other Identifiers

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CCM-002

Identifier Type: -

Identifier Source: org_study_id