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Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation

This study is currently recruiting participants.
Verified March 2013 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01339572
First received: April 15, 2011
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Multiple Myeloma
 Drug: Plerixafor
Drug: Filgrastim
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers [ Time Frame: Day 2 of apheresis ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Economic impact [ Time Frame: Day 2 of mobilization and Day +100 after transplantation ] [ Designated as safety issue: No ]
    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.

  • Kinetics of CD34+ mobilization with early introduction of plerixafor [ Time Frame: On Day 1 and Day 2 of apheresis ] [ Designated as safety issue: No ]

    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.

  • Graft composition [ Time Frame: On Day 1 and Day 2 of apheresis ] [ Designated as safety issue: No ]
    Graft composition will be analyzed on each day of successful apheresis. Cell populations to be quantitated include total CD3+ lymphocytes, CD4+ lymphocytes, CD8+ lymphocytes.


Estimated Enrollment: 250
Study Start Date: April 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: G-CSF

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01339572

Contacts
Contact: Diane Richardson 352-273-6844 drichardson@ufl.edu

Locations
United States, Florida
Shands Cancer Hospital at the University of Florida Recruiting
Gainesville, Florida, United States, 32608
Contact: Christine NeJame, RN     352-273-6838        
Principal Investigator: Jack W Hsu, MD            
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Jack W Hsu, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01339572     History of Changes
Other Study ID Numbers: Plerixafor-UF01
Study First Received: April 15, 2011
Last Updated: March 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
autologous transplantation
peripheral stem cell mobilization

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
 Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lenograstim
JM 3100
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013