Clinical trial · Interventional
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
NCT01292486CI-TRIAL-00010173completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Spectra Optia Apheresis System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with multiple myeloma
- description
- 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.
- interventionNames
- Device: Spectra Optia Apheresis System
Primary outcomes (1)
- measure
- Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery.
- timeFrame
- up to 28 days following transplant
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.