Alteration in Timing of Plerixafor Administration

Study Overview
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Brief Summary
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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.

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

Conditions
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Autologous Transplantation

Intervention / Treatment
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* Drug: Plerixafor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plerixafor 17 hours prior to apheresis<br>Dosing of plerixafor will occur at 3PM (1500 hours). | Drug: Plerixafor<br>* 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.<br>* Other names: Mozobil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autologous Transplantation