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NCT Number: NCT01339572

Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation

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.

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Key information

Conditions

Non-Hodgkin's Lymphoma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma 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

Shands Cancer Hospital at the University of Florida

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

plerixafor

Drug

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

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

Other names: AMD3100

Filgrastim

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 20, 2011
Registry last updated
Aug 1, 2017

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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