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The purpose of this investigation is to establish that hematopoetic stem cells collected on a new centrifugal blood separator, CaridianBCT's Spectra Optia Apheresis System, are able to reconstitute the hematopoetic systems of patients treated with myeloablative therapy, equivalent to hematopoetic cells harvested on the predicate COBE® Spectra platform.
This is a multi-center (3-5) single-arm study that will compare the performance of the Spectra Optia Apheresis System's MNC protocol to that of the historical performance of the COBE Spectra MNC protocol. In order to demonstrate the substantial equivalence of the two devices, a non-inferiority design will be used. The study will enroll patients with multiple myeloma who are to be treated with myeloablative chemotherapy, followed by bone-marrow rescue with an autologous peripheral blood stem-cell transplant. Peripheral blood stem cells will be collected using the Spectra Optia MNC protocol and re-infused following myeloablative chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with multiple myeloma | Experimental | Multiple myeloma patients who receive autologous stem-cell transplants, collected using the Spectra Optia Apheresis System, following myeloablative therapy. The study is limited to subjects who are expected demonstrate normal neutrophil recovery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectra Optia Apheresis System | Device | In this study, the safety and effectiveness of the new device will be assessed in two ways. First, MNC collections in growth-factor mobilized cancer patients will be evaluated to confirm that the Spectra Optia is able to collect stem cells. Second, following stem-cell collection and transplant, the number of days required for the collected hematopoetic stem cells to engraft/recover will be compared with historical COBE Spectra engraftment/recovery data. |
| Measure | Description | Time Frame |
|---|---|---|
| Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery. | Neutrophil recovery is defined as the day on which the peripheral blood absolute neutrophil count exceeds 500/μL (ANC500)for the first of three consecutive measurements obtained on different days following transplant of peripheral blood stem cells in patients treated with myeloablative therapy for their underlying disease. As this was a test of non-inferiority, the null hypothesis to be tested (H0) was that the difference between the observed day to neutrophil recovery and the historical median day of neutrophil recovery was greater than two days. At two of the enrolling sites, Duke and Emory Universities, the median day to ANC500 was 12, while at the other two sites, Indiana University and the University of Utah, it was 11 days. Consequently, in the equation below, site specific-historic medians were compared to the observed days to achieve ANC500. H0: D > |2|, where D = Observed median day of neutrophil recovery - Site specific historic median day of neutrophil recovery. | up to 28 days following transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Days Until Platelet Recovery | The time to platelet recovery is defined as the day following stem-cell transplant (Day 0) on which the platelet count exceeds 20,000/μL, for the first of three consecutive measurements obtained on different days, without platelet transfusion support within the preceding 7 days. | up to 28 days following transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerry R Bill, MD | Terumo BCT | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States | ||
| Indiana University |
This was a single arm study, which evaluated Multiple Myeloma patients who received autologous stem-cell transplants collected using the Spectra Optia Apheresis System, following myeloablative therapy. The study was limited to subjects who were expected to demonstrate normal neutrophil recovery.
Patients requiring a first peripheral blood stem cell collection and transplant for multiple myeloma were recruited at four clinical centers from March through October, 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Per Protocol Patients | This was a single arm study, which evaluated Multiple Myeloma patients who received autologous stem-cell transplants collected using the Spectra Optia Apheresis System, following myeloablative therapy. The study was limited to subjects who were expected to demonstrate normal neutrophil recovery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Multiple Myeloma | Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery. | Neutrophil recovery is defined as the day on which the peripheral blood absolute neutrophil count exceeds 500/μL (ANC500)for the first of three consecutive measurements obtained on different days following transplant of peripheral blood stem cells in patients treated with myeloablative therapy for their underlying disease. As this was a test of non-inferiority, the null hypothesis to be tested (H0) was that the difference between the observed day to neutrophil recovery and the historical median day of neutrophil recovery was greater than two days. At two of the enrolling sites, Duke and Emory Universities, the median day to ANC500 was 12, while at the other two sites, Indiana University and the University of Utah, it was 11 days. Consequently, in the equation below, site specific-historic medians were compared to the observed days to achieve ANC500. H0: D > |2|, where D = Observed median day of neutrophil recovery - Site specific historic median day of neutrophil recovery. | Twenty-six patients were evaluable per protocol. | Posted | Median | Full Range | Days | up to 28 days following transplant |
During stem cell collection (3-6 hours) and following reinfusion of collected stem cell product until neutrophil recovery (1-28 days).
Two participants were removed from the study before they underwent a collection on the Spectra Optia Apheresis System and were not at risk.
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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 | Patients With Multiple Myeloma | Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever and hypotension | Infections and infestations | Systematic Assessment | Blood cultures were negative but patient was hospitalized for antibiotic administration. Patient recovered and event judged to unrelated to the device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Citrate Reaction | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jerome R Bill, M.D. | Terumo BCT | 303-231-4729 | jerry.bill@terumobct.com |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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|
| CD34+ Cell Collection Efficiency. | Collection efficiency (CE) is defined as the percentage of any given cellular subset, processed by the system, that is collected from the subject. CD34+ is a cell surface marker found on pluripotent hematopoeitic stem cells. | up to 7 days |
| Mononuclear Cel (MNC) Collection Efficiency | Collection efficiency (CE) is defined as the percentage of any given cellular subset, processed by the system, that is collected from the subject. Determination of collection efficiency depends on an estimate of the average concentration of target cells in the patient's blood. Because these cells are continuously being removed during the collection, and are undergoing variable replacement from the bone marrow, this estimate will not be completely accurate. Underestimation of the concentration of target cells processed can lead to collection efficiencies of greater than 100%. | up to 7 days |
| Platelet Collection Efficiency | Platelet contamination of the cell product was measured as the platelet collection efficiency, that is, as the percent of platelets processed that were collected. | up to 7 days |
| Hematocrit of MNC Product | The hematocrit of the collected product was used to quantitate Red Blood Cell (RBC) contamination. | 7 days |
| Granulocyte % of MNC Product | Granulocyte contamination of the MNC product was quantitated as the percent of total product White Blood Cells (WBC) that were segmented granulocytes or bands. | 7 days |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| Physician Decision |
|
| Participants |
|
| Age Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | Patients With Multiple Myeloma | Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant. |
|
|
|
| Secondary | Days Until Platelet Recovery | The time to platelet recovery is defined as the day following stem-cell transplant (Day 0) on which the platelet count exceeds 20,000/μL, for the first of three consecutive measurements obtained on different days, without platelet transfusion support within the preceding 7 days. | All per protocol patients for whom platelet recovery data was available. | Posted | Median | Full Range | days | up to 28 days following transplant |
|
|
|
| Secondary | CD34+ Cell Collection Efficiency. | Collection efficiency (CE) is defined as the percentage of any given cellular subset, processed by the system, that is collected from the subject. CD34+ is a cell surface marker found on pluripotent hematopoeitic stem cells. | Data to calculate CD34+ cell collection efficiency was available for 39 collections on 24 of 26 per protocol patients. | Posted | Median | Full Range | % of processed CD34+ cells collected | up to 7 days | MNC collections | Participants |
|
|
|
| Secondary | Mononuclear Cel (MNC) Collection Efficiency | Collection efficiency (CE) is defined as the percentage of any given cellular subset, processed by the system, that is collected from the subject. Determination of collection efficiency depends on an estimate of the average concentration of target cells in the patient's blood. Because these cells are continuously being removed during the collection, and are undergoing variable replacement from the bone marrow, this estimate will not be completely accurate. Underestimation of the concentration of target cells processed can lead to collection efficiencies of greater than 100%. | Data was available to calculate MNC collection efficiency on 35 collections performed on 22 of the 26 per protocol patients. | Posted | Median | Full Range | % of processed MNCs that were collected | up to 7 days | MNC collections | Participants |
|
|
|
| Secondary | Platelet Collection Efficiency | Platelet contamination of the cell product was measured as the platelet collection efficiency, that is, as the percent of platelets processed that were collected. | Data to calculate platelet collection efficiency was available for 38 MNC collections on 24 of the 26 per protocol patients. | Posted | Median | Full Range | % of processed platelets collected | up to 7 days | MNC collections | Participants |
|
|
|
| Secondary | Hematocrit of MNC Product | The hematocrit of the collected product was used to quantitate Red Blood Cell (RBC) contamination. | Data was available from 38 MNC collections from 25 of the 26 per protocol patients. | Posted | Median | Full Range | hematocrit % | 7 days | MNC collections | Participants |
|
|
|
| Secondary | Granulocyte % of MNC Product | Granulocyte contamination of the MNC product was quantitated as the percent of total product White Blood Cells (WBC) that were segmented granulocytes or bands. | Data to calculate the percent of product WBCs that were segmented granulocytes or bands was available for 38 MNC collections on 25 of the 26 per protocol patients. | Posted | Median | Full Range | percentage of product WBCs | 7 days | MNC collections | Participants |
|
|
|
| 2 |
| 30 |
| 7 |
| 30 |
|
| Pneumonia/Sepsis | Infections and infestations | Systematic Assessment | Required inpatient hospitalization and antibiotics. Patient recovered. Unrelated to the device. |
|
| Fever | Infections and infestations | Systematic Assessment | Fever post ahpheresis, pre-apheresis and product cultures negative.Patient recovered.Unrelated to the device. Fever/chills post apheresis, preapheresis blood culture positive.Patient recovered.Unrelated to the device. |
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| 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 |