Skip to main content
OpenTrials
Completed

NCT Number: NCT01149863

Alteration in Timing of Plerixafor Administration

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autologous Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

plerixafor

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.

Other names: AMD3100, Mozobil

Primary outcomes

  1. Number of Patients Who Collected ≥ 6 x 10^6 CD34+ Cells by Day 5 (4 Apheresis Sessions) With Plerixafor Administration at 1500.

    Time frame: Within the first 5 days following plerixafor initiation

Secondary outcomes

  1. Number of Patients Who on Day 1 Collected > 10 x 10^6 CD34+ Cells/kg Following Plerixafor Dosing at 1500 Hrs

    Time frame: Within the first 5 days following plerixafor initiation

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Genzyme, a Sanofi Company

Registry information

Official study title

WCI1680-09: Evaluation of Alterations in Time of Administration of Plerixafor (Mozobil ®, AMD3100) in Combination With G-CSF on Safety and CD34+ Cell Mobilization

Important dates

Study start
2010
Primary completion
2011
First posted
Jun 24, 2010
Registry last updated
Dec 13, 2013

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.