Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection

Study Overview
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Brief Summary
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The purpose of this study is to test whether the addition of the drug plerixafor to treatment with chemotherapy and G-CSF can better activate your bone marrow stem cells to improve the chances of transplant. The study will look for the activation of a certain type of blood cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and G-CSF. The investigators will follow the number of patients that achieve the target numbers of CD34+ cells. The number of patients achieving the target level of CD34+ cells, and the total number of CD34+ cells, will be compared to the numbers in previous studies testing just chemotherapy and G-CSF, without plerixafor. The investigators will also test the safety of the combination of plerixafor with chemotherapy and G-CSF and look at the success of the transplantation after 12 months.

Official Title
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Evaluation of Plerixafor (Mozobil ™, AMD3100) in Combination With Chemotherapy and G-CSF for CD34+ Cell Mobilization

Conditions
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Myeloma, Lymphoma

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 Multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL) patients in first or second complete or partial remission Eastern Cooperative Oncology Group (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 white blood cells (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 aspartate aminotransferase (AST)/alanine aminotransferase (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-hematopoietic progenitor cells (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
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Plerixafor + Chemo and G-CSF<br>Patients who receive a combination of Plerixafor, chemotherapy and G-CSF. | Drug: Plerixafor<br>* 240 µg/kg subcutaneous injection on the day that the absolute neutrophil count (ANC) is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.<br>* Other names: AMD3100;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis |  | Within the first 4 days following the first dose of Plerixafor | 
| Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg |  | Within the first 4 days following the first dose of Plerixafor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500) |  | Within the first 4 days following the first dose of Plerixafor | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myeloma, Lymphoma, Stem cell transplantation