Alteration in Timing of Plerixafor Administration

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

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.

Study Overview

• Status: Completed
• Conditions: Autologous Transplantation
• Intervention / Treatment: Drug: Plerixafor

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Winship Cancer Institute

Participation Criteria

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Plerixafor 17 hours prior to apheresis; Dosing of plerixafor will occur at 3PM (1500 hours).	Drug: 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.; Other Names: AMD3100; Mozobil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Patients Who Collected ≥ 6 x 10^6 CD34+ Cells by Day 5 (4 Apheresis Sessions) With Plerixafor Administration at 1500.	Within the first 5 days following plerixafor initiation

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Patients Who on Day 1 Collected > 10 x 10^6 CD34+ Cells/kg Following Plerixafor Dosing at 1500 Hrs	Within the first 5 days following plerixafor initiation

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Genzyme, a Sanofi Company
• Investigators: Principal Investigator: R. Donald Harvey, PharmD, FCCP, Emory University Winship Cancer Institute

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: June 22, 2010
• First Submitted That Met QC Criteria: June 23, 2010
• First Posted (Estimate): June 24, 2010

Study Record Updates

• Last Update Posted (Estimate): December 13, 2013
• Last Update Submitted That Met QC Criteria: November 19, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Autologous Transplantation
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Plerixafor
• Other Study ID Numbers: IRB00034057; WCI1680-09 (Other Identifier: Other)