Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation

Study Overview
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Brief Summary
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This protocol will investigate the effectiveness of plerixafor in the up-front setting in avoiding a second round of mobilization and whether this translates into a clinical and economic benefit.

Detailed Description
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Peripheral blood stem cells are now considered the standard source of stem cells for autologous stem cell transplants. Unfortunately, there is still a 20-30% chance that inadequate numbers of stem cells will be collected, resulting in prolonged recovery of cell counts after transplantation and increased transfusion dependence. There is also a significant economic burden associated with remobilization and a risk that delays in collecting sufficient numbers of stem cells can result in an increased chance of disease recurrence prior to transplantation.

Official Title
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Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation

Conditions
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Non-Hodgkin's Lymphoma, Multiple Myeloma

Intervention / Treatment
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* Drug: Plerixafor
* Drug: Filgrastim


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with multiple myeloma or non-Hodgkin's lymphoma with a planned autologous transplant and who are eligible for peripheral stem cell mobilization. Karnofsky Performance Status ≥ 70. Age ≥ 18 Less than 30% involvement of marrow with disease. Exclusion Criteria: > 30% marrow involvement with disease Age < 18. Pregnant women.

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plerixafor<br>All subjects will receive filgrastim as part of their primary mobilization regimen. If a subject does not meet minimum peripheral blood CD34+ cell count levels or fails to adequately collect a threshold number of CD34+ cells, plerixafor will be added to the mobilization regimen. | Drug: Plerixafor<br>* 240 mcg/kg/day based on ideal body weight will be given for the following conditions: Pre-apheresis peripheral blood CD34+ count <20 cells/μL on day 5. Estimated CD34+ cell collection is < 25% of target cell dose after 1 day of apheresis. Estimated CD34+ cell collection is < 50% of target cell dose after 2 days of apheresis.<br>* Other names: AMD3100;Drug: Filgrastim<br>* All patients will receive filgrastim starting 4 days prior to apheresis (D1-4 mobilization). The dose and schedule of filgrastim will based upon the risk category of the patient: Standard risk: 5 μg/kg SQ BID. High risk: 10 μg/kg SQ BID.<br>* Other names: G-CSF;|
| Active Comparator: Observation<br>All subjects will receive filgrastim as part of their primary mobilization regimen. If the subject meets minimum peripheral blood CD34+ cell count levels or adequately collects a threshold number of CD34+ cells, plerixafor will not be added to the mobilization regimen. | Drug: Filgrastim<br>* All patients will receive filgrastim starting 4 days prior to apheresis (D1-4 mobilization). The dose and schedule of filgrastim will based upon the risk category of the patient: Standard risk: 5 μg/kg SQ BID. High risk: 10 μg/kg SQ BID.<br>* Other names: G-CSF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers | The primary endpoint of the study will be the rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers based on peripheral blood CD34+ cell counts or CD34+ cell collection efficiency after 2 consecutive days of apheresis. Success will be defined as the ability to avoid a second mobilization attempt. Results will be compared to matched historical controls. | Day 2 of apheresis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Economic impact | The economic impact of plerixafor use will be divided into two phases, mobilization and transplantation. The comparator arm for the mobilization phase would be matched historical controls. The comparator arm for the transplant phase will be patients who did not require plerixafor for mobilization during the study period. | Day 2 of mobilization and Day +100 after transplantation | 
| Kinetics of CD34+ mobilization with early introduction of plerixafor | The kinetics of CD34+ cell counts during mobilization in this setting is unknown. We will attempt to determine mobilization kinetics by following peripheral blood CD34+ counts daily starting from first day of plerixafor administration until completion of apheresis. Kinetics will be analyzed according to the following parameters: Peripheral CD34 cell counts on each day of apheresis. Total CD34 cells collected on each day of apheresis Multiple myeloma vs. NHL. | On Day 1 and Day 2 of apheresis | 
| Graft composition | Graft composition will be analyzed on each day of successful apheresis. Cell populations to be quantitated include total CD3+ lymphocytes, CD4+ lymphocytes, CD8+ lymphocytes. | On Day 1 and Day 2 of apheresis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autologous transplantation, peripheral stem cell mobilization