Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure

NCT ID: NCT01292486

Last Updated: 2013-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-12-31

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Spectra Optia Apheresis System

Intervention Type: 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.

Interventions

Spectra Optia Apheresis System

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Terumo BCT

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerry R Bill, MD

Role: STUDY_DIRECTOR

Terumo BCT

Locations

Emory University

Atlanta, Georgia, United States

Indiana University

Indianapolis, Indiana, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

BCT10-02

Identifier Type: -

Identifier Source: org_study_id