Alteration in Timing of Plerixafor Administration

Autologous Transplantation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01149863
• Other study ID #: IRB00034057
• Secondary ID: WCI1680-09
• Status: Completed
• Phase: Phase 2
• First received: June 22, 2010
• Last updated: November 19, 2013
• Start date: June 2010

Study information

• Verified date: May 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autologous Transplantation

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University Winship Cancer Institute	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes