Clinical trial NCT01149863: Alteration in Timing of Plerixafor Administration
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autologous Transplantation
Keywords: Autologous Transplantation
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2010-06-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients Who Collected ≥ 6 x 10^6 CD34+ Cells by Day 5 (4 Apheresis Sessions) With Plerixafor Administration at 1500.
timeFrame: Within the first 5 days following plerixafor initiation
Secondary outcomes:
measure: Number of Patients Who on Day 1 Collected > 10 x 10^6 CD34+ Cells/kg Following Plerixafor Dosing at 1500 Hrs
timeFrame: Within the first 5 days following plerixafor initiation
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Winship Cancer Institute
name: R. Donald Harvey, PharmD, FCCP
role: PRINCIPAL_INVESTIGATOR
References: