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Alteration in Timing of Plerixafor Administration

NCT ID: NCT01149863

Last Updated: 2013-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Brief Summary

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Typically, the collection of blood cells for autologous stem cell transplant is done after the drugs granulocyte colony-stimulating factor (G-CSF) and plerixafor have been given to activate the bone marrow stem cells to produce a certain type of blood cell, called CD34+ cells. Currently, plerixafor is given in the evening, about 11 hours before apheresis (removal of blood) begins the following morning. The purpose of this study is to test whether plerixafor can instead be given 17 hours before apheresis. This timing would be more convenient since plerixafor would be given during normal clinic hours, and so patients would be within a clinic environment if any side effects develop.

The study will look for the activation of CD34+ cells in patients who receive plerixafor 17 hours before apheresis. We will follow the number of patients that achieve the target numbers of CD34+ cells, and the total number of CD34+ cells collected. These will be compared to the numbers in previous studies giving plerixafor 11 hours before apheresis.

We will also assess the safety of giving plerixafor 17 hours before apheresis.

Detailed Description

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Conditions

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Autologous Transplantation

Keywords

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Autologous Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Plerixafor 17 hours prior to apheresis

Dosing of plerixafor will occur at 3PM (1500 hours).

Group Type EXPERIMENTAL

Plerixafor

Intervention Type DRUG

Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses.

Interventions

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Plerixafor

Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses.

Intervention Type DRUG

Other Intervention Names

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AMD3100 Mozobil

Eligibility Criteria

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Inclusion Criteria

1. Age 18-70 years
2. MM patients in first or second complete or partial remission
3. ECOG performance status of 0 or 1
4. Up to 3 prior treatment regimens
5. Meet all eligibility requirements for autologous transplant
6. Adequate marrow function defined as WBC \>3,000; ANC \>1,500/mm3 ; Platelets \>75,000/mm3
7. Adequate renal function defined as creatinine clearance \> 30 mL/min by Cockcroft-Gault
8. Adequate liver function defined as AST/ALT/Bilirubin \< 2 times upper limit of normal
9. Able to provide informed consent
10. Women not pregnant and agree to use contraception

Exclusion Criteria

1. High risk co-morbidities for acute treatment complications (e.g., symptomatic coronary artery disease)
2. Brain metastases or carcinomatous meningitis
3. Previous treatment with high dose chemotherapy and autologous transplant.
4. Previous attempt to collect B-HPCs following mobilization with growth factors alone, growth factors and chemotherapy, or plerixafor and growth factors.
5. Acute infection or unexplained fever \>38°C
6. Weight \> 175% of ideal body weight as defined by the Devine equation.
7. Experimental therapy within 4 weeks
8. Cytokine administration in the previous 14 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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R. Donald Harvey, PharmD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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R. Donald Harvey, PharmD, FCCP

Role: PRINCIPAL_INVESTIGATOR

Emory University Winship Cancer Institute

Locations

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Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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WCI1680-09

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00034057

Identifier Type: -

Identifier Source: org_study_id