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| ID | Type | Description | Link |
|---|---|---|---|
| 7445 | Other Identifier | Other |
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Accrual goal met
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The purpose of this study is to determine whether or not the injection site of cytokines, or growth factors, has an effect on peripheral blood stem cell collection.
The purpose of this study is to determine the preferred injection site for G-CSF and GM-CSF, which are cytokines, or growth factors. The doctor may also choose to use these growth factors in combination with chemotherapy to increase the number of stem cells in the blood. Both options are established and are effective in increasing the number of stem cells in the blood.
Patients will receive one shot under the skin twice a day for approximately 12-15 days after receiving chemotherapy through the time your cells are being collected. Patients will be randomly assigned to receive growth factors administered either to their abdomen or to their extremities. Both shots will always be given either in the abdomen or in the extremities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdomen | Active Comparator | These subjects will have their cytokine injections administered only to their abdomen. |
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| Extremities | Active Comparator | The extremity arm will have their injections administered to their upper and/or lower extremities. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-CSF, GM-CSF administered at extremities | Drug | Injection site Extremities: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a twice daily schedule of G-CSF/GM-CSF until stem cell collection is complete. |
| Measure | Description | Time Frame |
|---|---|---|
| The Total Number of CD34+ Cells Collected. | 4 days | |
| Number of Participants for Whom Target Number of CD34+ Cells Were Collected. | Target numbers of CD34+ cells for a single autologous transplant are typically at least 5.0 * 10^6 cells/kg, a cell dose that consistently results in rapid cell engraftment | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Days of Apheresis | the number of days of apheresis required to collect target numbers of CD34+ cells. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edmund Waller, MD | Emory University Winship Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Abdomen | These subjects will have their cytokine injections administered only to their abdomen. |
| FG001 | Extremities | The extremity arm will have their injections administered to their upper and/or lower extremities. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| G-CSF and GMCSF administered at abdomen | Drug | Injection site Abdomen: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a BID schedule of G-CSF/GM-CSF until stem cell collection is complete. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Abdomen | These subjects will have their cytokine injections administered only to their abdomen. |
| BG001 | Extremities | The extremity arm will have their injections administered to their upper and/or lower extremities. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | Mean |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Disease type | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Total Number of CD34+ Cells Collected. | Patients at our institution between the ages of 18 and 70 years old with relapsed or refractory Hodgkin's disease, non-Hodgkin's lymphoma, or mutiple myelomawhowere scheduled for an autologous HSCTwere eligible to participate in the study. | Posted | Mean | Standard Deviation | cells per Kg | 4 days |
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| Secondary | Total Number of Days of Apheresis | the number of days of apheresis required to collect target numbers of CD34+ cells. | Posted | Mean | Standard Deviation | days | 7 days |
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| Primary | Number of Participants for Whom Target Number of CD34+ Cells Were Collected. | Target numbers of CD34+ cells for a single autologous transplant are typically at least 5.0 * 10^6 cells/kg, a cell dose that consistently results in rapid cell engraftment | Posted | Number | participants | 7 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abdomen | These subjects will have their cytokine injections administered only to their abdomen. | 0 | 18 | 18 | 18 | ||
| EG001 | Extremities | The extremity arm will have their injections administered to their upper and/or lower extremities. | 0 | 17 | 17 | 17 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone Pain | Musculoskeletal and connective tissue disorders |
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| Redness at the injection site | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edmund Waller, MD, PhD | Emory University Winship Cancer Institute | 1-888-946-7447 | ewaller@emory.edu |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| C081222 | sargramostim |
| D036341 | Intercellular Signaling Peptides and Proteins |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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| Male |
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| Myeloma |
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