Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation

July 27, 2017 updated by: University of Florida
This protocol will investigate the effectiveness of plerixafor in the up-front setting in avoiding a second round of mobilization and whether this translates into a clinical and economic benefit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Peripheral blood stem cells are now considered the standard source of stem cells for autologous stem cell transplants. Unfortunately, there is still a 20-30% chance that inadequate numbers of stem cells will be collected, resulting in prolonged recovery of cell counts after transplantation and increased transfusion dependence. There is also a significant economic burden associated with remobilization and a risk that delays in collecting sufficient numbers of stem cells can result in an increased chance of disease recurrence prior to transplantation.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • Shands Cancer Hospital at the University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with multiple myeloma or non-Hodgkin's lymphoma with a planned autologous transplant and who are eligible for peripheral stem cell mobilization.
  • Karnofsky Performance Status ≥ 70.
  • Age ≥ 18
  • Less than 30% involvement of marrow with disease.

Exclusion Criteria:

  • > 30% marrow involvement with disease
  • Age < 18.
  • Pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Plerixafor
All subjects will receive filgrastim as part of their primary mobilization regimen. If a subject does not meet minimum peripheral blood CD34+ cell count levels or fails to adequately collect a threshold number of CD34+ cells, plerixafor will be added to the mobilization regimen.
Drug: Plerixafor

240 mcg/kg/day based on ideal body weight will be given for the following conditions:

  1. Pre-apheresis peripheral blood CD34+ count <20 cells/μL on day 5.
  2. Estimated CD34+ cell collection is < 25% of target cell dose after 1 day of apheresis.
  3. Estimated CD34+ cell collection is < 50% of target cell dose after 2 days of apheresis.
Other Names:
  • AMD3100
Drug: Filgrastim

All patients will receive filgrastim starting 4 days prior to apheresis (D1-4 mobilization). The dose and schedule of filgrastim will based upon the risk category of the patient:

  • Standard risk: 5 μg/kg SQ BID.
  • High risk: 10 μg/kg SQ BID.
Other Names:
  • G-CSF
Active Comparator: Observation
All subjects will receive filgrastim as part of their primary mobilization regimen. If the subject meets minimum peripheral blood CD34+ cell count levels or adequately collects a threshold number of CD34+ cells, plerixafor will not be added to the mobilization regimen.
Drug: Filgrastim

All patients will receive filgrastim starting 4 days prior to apheresis (D1-4 mobilization). The dose and schedule of filgrastim will based upon the risk category of the patient:

  • Standard risk: 5 μg/kg SQ BID.
  • High risk: 10 μg/kg SQ BID.
Other Names:
  • G-CSF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers
Time Frame: Day 2 of apheresis
The primary endpoint of the study will be the rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers based on peripheral blood CD34+ cell counts or CD34+ cell collection efficiency after 2 consecutive days of apheresis. Success will be defined as the ability to avoid a second mobilization attempt. Results will be compared to matched historical controls.
Day 2 of apheresis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Economic impact
Time Frame: Day 2 of mobilization and Day +100 after transplantation
The economic impact of plerixafor use will be divided into two phases, mobilization and transplantation. The comparator arm for the mobilization phase would be matched historical controls. The comparator arm for the transplant phase will be patients who did not require plerixafor for mobilization during the study period.
Day 2 of mobilization and Day +100 after transplantation
Kinetics of CD34+ mobilization with early introduction of plerixafor
Time Frame: On Day 1 and Day 2 of apheresis

The kinetics of CD34+ cell counts during mobilization in this setting is unknown. We will attempt to determine mobilization kinetics by following peripheral blood CD34+ counts daily starting from first day of plerixafor administration until completion of apheresis. Kinetics will be analyzed according to the following parameters:

  • Peripheral CD34 cell counts on each day of apheresis.
  • Total CD34 cells collected on each day of apheresis
  • Multiple myeloma vs. NHL.
On Day 1 and Day 2 of apheresis
Graft composition
Time Frame: On Day 1 and Day 2 of apheresis
Graft composition will be analyzed on each day of successful apheresis. Cell populations to be quantitated include total CD3+ lymphocytes, CD4+ lymphocytes, CD8+ lymphocytes.
On Day 1 and Day 2 of apheresis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Jack W Hsu, MD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

April 15, 2011

First Submitted That Met QC Criteria

April 19, 2011

First Posted (Estimate)

April 20, 2011

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 27, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Plerixafor-UF01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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