Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure

NCT01292486 | Completed Results

• 1 other identifier: BCT10-02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Days Until Platelet Recovery

  up to 28 days following transplant

• CD34+ Cell Collection Efficiency.

  up to 7 days

• Mononuclear Cel (MNC) Collection Efficiency

  up to 7 days

• Platelet Collection Efficiency

  up to 7 days

• Hematocrit of MNC Product

  7 days

Study Arms (1)

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.

Device: Spectra Optia Apheresis System

Interventions

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.

Patients with multiple myeloma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Terumo BCT: lead

Study Sites (4)

Emory University

Atlanta, Georgia, 30322, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jerome R Bill, M.D.
• Organization: Terumo BCT

jerry.bill@terumobct.com

303-231-4729

Study Officials

• Jerry R Bill, MD

  Terumo BCT

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2011
• First Posted: February 9, 2011
• Study Start: February 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 1, 2013
• Results First Posted: May 1, 2013

Record last verified: 2013-04

Locations

US (4)