Trial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for Poor Stem Cell Mobilization

Study Overview
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Brief Summary
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Poor mobilization of hematopoietic progenitors needed to support autologous transplantation is a serious clinical problem. We are investigating the role of plerixafor administered in an at risk population to augment successful stem cell collection. OBJECTIVES To determine if plerixafor when administered on the day prior to planned autologous collection on first mobilization attempt in those with a peripheral blood CD34 ≤ 10X106/L will: increase the number of patients successfully collected in one day increase the number of patients successfully mobilized on first collection attempt is cost neutral within a Canadian setting

Official Title
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Open Label Phase II Trial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for Poor Stem Cell Mobilization

Conditions
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Multiple Myeloma, Lymphoma

Intervention / Treatment
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* Drug: Plerixafor
* Other: Observation: Nonintervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be 18 years of age or older Patients must be able to provide written consent Participants must have a diagnosis of lymphoma or multiple myeloma and be undergoing autologous stem cell mobilization for the purposes of ASCT Females of child bearing age will be asked to use an approved form of contraception Exclusion Criteria: Patients who are pregnant or breastfeeding Patients whose creatinine ≥ 250 μM Serum AST, ALT or total bilirubin >5X upper limit of normal Acute infection

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Successful Mobilizers<br>Successful Mobilizers are defined as having a peripheral blood CD34 > 10X106/L. | Other: Observation: Nonintervention<br>* Nonintervention group, no drug will be given, observation only<br>|
| Experimental: Poor Mobilizers<br>Poor Mobilizer are defined as patients who on Day -1 have a peripheral blood [CD34] ≤ 10 X106/L | Drug: Plerixafor<br>* Plerixafor will be administered at 23:00 of Day -1 to experimental subjects at a dose of 240 mcg/kg subcutaneously, and possibly repeated the following day<br>* Other names: Mozobil®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected in one day. The anticipated proportion increase is from 30%-60%. |  | within 1-2 days after commencing therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected on first mobilization attempt rather than requiring a second mobilization. |  | After therapy | 
| To describe the kinetics of platelet and neutrophil recovery post ASCT in those treated and not treated with plerixafor |  | After therapy | 
| To examine the immune recovery at day 100 post ASCT in those treated and not treated with plerixafor |  | After therapy | 
| To undertake a pharmacoeconomic evaluation to examine the impact of plerixafor on resource utilization in a population at risk for poor mobilization |  | After therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myeloma, Multiple Myeloma or Lymphoma Patients undergoing, mobilization for the purpose of autologous stem cell collection