Back to resultsEvaluation of the Spectra Optia® Mononuclear Cell Collection Procedure
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spectra Optia Apheresis System
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- Histologic confirmation of Multiple Myeloma
- Patients intended to be treated with myeloablative therapy and autologous hematopoetic stem-cell transplant within one month of stem-cell collection
- Patients whose stem-cell mobilization regimen includes G-CSF (granulocyte-colony stimulating factor)
- Males or non-pregnant females, who are 18 years of age or older
- Karnofsky score of ≥70%
Exclusion Criteria:
- Patients with pre-mobilization platelet count < 75,000/µL
- Patients who have received pelvic bone marrow irradiation as part of their conditioning therapy
- Patients who have had a previous hematopoetic stem-cell transplant
- Patients who have had a previous hematopoetic stem-cell collection failure
- Impaired cardiac function, as evidenced by left ventricular ejection fraction <40%.
- Impaired hepatic function, as evidenced by alanine transaminase >2.5 x normal
- Impaired pulmonary function as evidenced by diffusion capacity of the lung for carbon monoxide (adjusted for patient hematocrit, if indicated) or forced expiratory volume in 1 second <50% of predicted
- Impaired renal function, as evidenced by a creatinine clearance < 40 mL/min
- Impaired coagulation, as evidenced by a prothrombin time (PT) > twice normal
- Pregnancy or lactation
- Seropositivity for Human Immunodeficiency Virus-1/2, Hepatitis B Virus, or Hepatitis C Virus
- Documented bacterial or fungal infection that requires intravenous antibiotics to be started or continued while undergoing apheresis collection on the Spectra Optia device
- Subjects enrolled in study protocols that could affect number of CD34+ cells (pluripoten hematopoetic stem stells) collected or kinetics of neutrophil recovery
- Altered mental status, as evidenced by the inability to provide effective informed consent
Sites / Locations
- Emory University
- Indiana University
- Duke University Medical Center
- University of Utah
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with multiple myeloma
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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%.
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.
Hematocrit of MNC Product
The hematocrit of the collected product was used to quantitate Red Blood Cell (RBC) contamination.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01292486
Brief Title
Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure
Official Title
Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Multiple Myeloma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Terumo BCT
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with multiple myeloma
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Spectra Optia Apheresis System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery.
Description
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.
Time Frame
up to 28 days following transplant
Secondary Outcome Measure Information:
Title
Days Until Platelet Recovery
Description
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.
Time Frame
up to 28 days following transplant
Title
CD34+ Cell Collection Efficiency.
Description
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.
Time Frame
up to 7 days
Title
Mononuclear Cel (MNC) Collection Efficiency
Description
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%.
Time Frame
up to 7 days
Title
Platelet Collection Efficiency
Description
Platelet contamination of the cell product was measured as the platelet collection efficiency, that is, as the percent of platelets processed that were collected.
Time Frame
up to 7 days
Title
Hematocrit of MNC Product
Description
The hematocrit of the collected product was used to quantitate Red Blood Cell (RBC) contamination.
Time Frame
7 days
Title
Granulocyte % of MNC Product
Description
Granulocyte contamination of the MNC product was quantitated as the percent of total product White Blood Cells (WBC) that were segmented granulocytes or bands.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologic confirmation of Multiple Myeloma
Patients intended to be treated with myeloablative therapy and autologous hematopoetic stem-cell transplant within one month of stem-cell collection
Patients whose stem-cell mobilization regimen includes G-CSF (granulocyte-colony stimulating factor)
Males or non-pregnant females, who are 18 years of age or older
Karnofsky score of ≥70%
Exclusion Criteria:
Patients with pre-mobilization platelet count < 75,000/µL
Patients who have received pelvic bone marrow irradiation as part of their conditioning therapy
Patients who have had a previous hematopoetic stem-cell transplant
Patients who have had a previous hematopoetic stem-cell collection failure
Impaired cardiac function, as evidenced by left ventricular ejection fraction <40%.
Impaired hepatic function, as evidenced by alanine transaminase >2.5 x normal
Impaired pulmonary function as evidenced by diffusion capacity of the lung for carbon monoxide (adjusted for patient hematocrit, if indicated) or forced expiratory volume in 1 second <50% of predicted
Impaired renal function, as evidenced by a creatinine clearance < 40 mL/min
Impaired coagulation, as evidenced by a prothrombin time (PT) > twice normal
Pregnancy or lactation
Seropositivity for Human Immunodeficiency Virus-1/2, Hepatitis B Virus, or Hepatitis C Virus
Documented bacterial or fungal infection that requires intravenous antibiotics to be started or continued while undergoing apheresis collection on the Spectra Optia device
Subjects enrolled in study protocols that could affect number of CD34+ cells (pluripoten hematopoetic stem stells) collected or kinetics of neutrophil recovery
Altered mental status, as evidenced by the inability to provide effective informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry R Bill, MD
Organizational Affiliation
Terumo BCT
Official's Role
Study Director
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure
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