Alteration in Timing of Plerixafor Administration

NCT01149863 | Completed Phase 2 Results DMC

• 2 other identifiers: IRB00034057WCI1680-09
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autologous Transplantation

Keywords

Autologous Transplantation

Outcome Measures

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.

  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

  Within the first 5 days following plerixafor initiation

Study Arms (1)

Plerixafor 17 hours prior to apheresis

EXPERIMENTAL

Dosing of plerixafor will occur at 3PM (1500 hours).

Drug: Plerixafor

Interventions

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.

Also known as: AMD3100, Mozobil

Plerixafor 17 hours prior to apheresis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

plerixafor

Results Point of Contact

• Title: Dr. Harvey
• Organization: Emory University

rdharve@emory.edu

404-778-4381

Study Officials

• R. Donald Harvey, PharmD, FCCP

  Emory University Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: June 24, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2011
• Last Updated: December 13, 2013
• Results First Posted: July 8, 2013

Record last verified: 2013-05

Locations

US (1)