- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01292486
Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure
Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Multiple Myeloma Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
-
Utah
-
Salt Lake City, Utah, United States, 84108
- University of Utah
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with multiple myeloma
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery.
Time Frame: up to 28 days following transplant
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days Until Platelet Recovery
Time Frame: up to 28 days following transplant
|
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
|
CD34+ Cell Collection Efficiency.
Time Frame: up to 7 days
|
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
Time Frame: up to 7 days
|
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
Time Frame: up to 7 days
|
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
Time Frame: 7 days
|
The hematocrit of the collected product was used to quantitate Red Blood Cell (RBC) contamination.
|
7 days
|
Granulocyte % of MNC Product
Time Frame: 7 days
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jerry R Bill, MD, Terumo BCT
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- BCT10-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Myeloma
-
Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
-
National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
-
Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on Spectra Optia Apheresis System
-
Terumo BCTCompletedThrombocytosis | Thrombocythemia | Myeloproliferative DiseaseDenmark, Hungary
-
Terumo BCTCompletedLeukocytosisBelgium, Germany, Hungary
-
Terumo BCTCompletedHealthy Apheresis Donors | Mononuclear (MNC) Cell DonorsUnited States
-
Heinrich-Heine University, DuesseldorfChugai Pharma USA; Terumo BCTCompletedHealthy Allogeneic Donors | Granulocyte Colony-stimulating Factor (G-CSF) MobilizedGermany
-
IRCCS Policlinico S. MatteoCompleted
-
Marker Therapeutics AGTerumo BCTCompleted
-
Terumo BCTCompletedGranulocyte/ Polymorphonuclear CellsUnited States
-
Terumo BCTCompletedSickle Cell DiseaseUnited States
-
Boston Scientific CorporationCompletedBack Pain | Chronic PainUnited States
-
Endofotonics Pte LtdZhongshan Hospital Xiamen UniversityRecruitingGastric Cancer | Gastric Precancerous LesionChina