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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
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The purpose of this study is to determine whether it is safe and effective to collect peripheral blood hematopoietic stem cells 16 hours rather than the usual 11 hours after administration of plerixafor.
The current FDA-approved timing for plerixafor is approximately 11 hours prior to apheresis. This is a logistical problem, since plerixafor should be administered by a health care provider, given the risk of hypotension with administration. The primary purpose of this study is, in autologous donors with non-Hodgkins lymphoma and multiple myeloma undergoing hematopoietic progenitor cell mobilization with plerixafor and G-CSF, to determine whether the dosing interval can be increased to 16 hours prior to apheresis. Patients will be admitted to a special clinical research center on the 4th day of G-CSF administration, where the peripheral blood CD34+ count will be measured every 2 hours after plerixafor administration at 5 pm until 9 AM the following day, at which time apheresis will commence. The hypothesis is that plerixafor administration 16 hours prior to apheresis is as safe and effective as plerixafor administration at 11 hours prior to apheresis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plerixafor | Experimental | Plerixafor 16 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plerixafor | Drug | Plerixafor administered at 16 hours prior to apheresis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of donors obtaining a minimum CD34+ cell dose of 2 x 106/kg actual recipient weight within 2 days of collection | After collection |
| Measure | Description | Time Frame |
|---|---|---|
| Median and average neutrophil and platelet engraftment | After stem cell infusion | |
| Plerixafor-related toxicities | 1 month after stem cell infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia A Shi, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai School of Medicine | Recruiting | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15752146 | Background | Liles WC, Rodger E, Broxmeyer HE, Dehner C, Badel K, Calandra G, Christensen J, Wood B, Price TH, Dale DC. Augmented mobilization and collection of CD34+ hematopoietic cells from normal human volunteers stimulated with granulocyte-colony-stimulating factor by single-dose administration of AMD3100, a CXCR4 antagonist. Transfusion. 2005 Mar;45(3):295-300. doi: 10.1111/j.1537-2995.2005.04222.x. | |
| 19720922 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C088327 | plerixafor |
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| Background |
| DiPersio JF, Micallef IN, Stiff PJ, Bolwell BJ, Maziarz RT, Jacobsen E, Nademanee A, McCarty J, Bridger G, Calandra G; 3101 Investigators. Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma. J Clin Oncol. 2009 Oct 1;27(28):4767-73. doi: 10.1200/JCO.2008.20.7209. Epub 2009 Aug 31. |
| D014652 |
| Vascular Diseases |
| 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 |
| D008223 | Lymphoma |
| D008206 | Lymphatic Diseases |