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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Successful Mobilizers | Active Comparator | Successful Mobilizers are defined as having a peripheral blood CD34 > 10X106/L. |
|
| Poor Mobilizers | Experimental | Poor Mobilizer are defined as patients who on Day -1 have a peripheral blood [CD34] ⤠10 X106/L |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plerixafor | Drug | 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 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
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| Label | URL |
|---|---|
| Official CancerCare Manitoba Website | View source |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C088327 | plerixafor |
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|
| Observation: Nonintervention | Other | Nonintervention group, no drug will be given, observation only |
|
| 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 |
| D002318 |
| Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008206 | Lymphatic Diseases |