N/A
N=32
Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT01292486 ↗Enrolled (actual)
32
Serious AEs
6.7%
Results posted
May 2013
Primary outcome: Primary: Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery. — 0 Days — p=<0.025
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Spectra Optia Apheresis System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Terumo BCT
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery. |
— | <0.025 sig |
| SECONDARY Days Until Platelet Recovery |
20 | — |
| SECONDARY CD34+ Cell Collection Efficiency. |
70 | — |
| SECONDARY Mononuclear Cel (MNC) Collection Efficiency |
60 | — |
| SECONDARY Platelet Collection Efficiency |
19 | — |
| SECONDARY Hematocrit of MNC Product |
1.8 | — |
| SECONDARY Granulocyte % of MNC Product |
29.0 | — |
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.
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 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 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
Data sourced from ClinicalTrials.gov (NCT01292486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.