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NCT Number: NCT01292486

Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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%.

  4. 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.

  5. Hematocrit of MNC Product

    Time frame: 7 days

    The hematocrit of the collected product was used to quantitate Red Blood Cell (RBC) contamination.

  6. 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.

Sponsors and collaborators

Lead sponsor

Terumo BCT

Industry

Registry information

Official study title

Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Multiple Myeloma Patients

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 9, 2011
Registry last updated
May 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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