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

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Multiple Myeloma

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery.

Outcome 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.

Outcome Time Frame:

up to 28 days following transplant

Safety Issue:


Principal Investigator

Jerry R Bill, MD

Investigator Role:

Study Director

Investigator Affiliation:

Terumo BCT


United States: Food and Drug Administration

Study ID:




Start Date:

February 2011

Completion Date:

December 2011

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



University of Utah Salt Lake City, Utah  
Duke University Medical Center Durham, North Carolina  27710
Emory University Atlanta, Georgia  30322
Indiana University Indianapolis, Indiana  46202