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Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01292486
First Posted: February 9, 2011
Last Update Posted: May 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Terumo BCT
Results First Submitted: September 14, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Multiple Myeloma
Intervention: Device: Spectra Optia Apheresis System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients requiring a first peripheral blood stem cell collection and transplant for multiple myeloma were recruited at four clinical centers from March through October, 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was a single arm study, which evaluated Multiple Myeloma patients who received autologous stem-cell transplants collected using the Spectra Optia Apheresis System, following myeloablative therapy. The study was limited to subjects who were expected to demonstrate normal neutrophil recovery.

Reporting Groups
  Description
All Per Protocol Patients This was a single arm study, which evaluated Multiple Myeloma patients who received autologous stem-cell transplants collected using the Spectra Optia Apheresis System, following myeloablative therapy. The study was limited to subjects who were expected to demonstrate normal neutrophil recovery.

Participant Flow:   Overall Study
    All Per Protocol Patients
STARTED   32 
COMPLETED   26 
NOT COMPLETED   6 
Protocol Violation                2 
Did not meet screening criteria                2 
Adverse Event                1 
Physician Decision                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Patients With Multiple Myeloma Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.

Baseline Measures
   Patients With Multiple Myeloma 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   20 
>=65 years   12 
Age 
[Units: Years]
Median (Full Range)
 63 
 (39 to 74) 
Gender 
[Units: Participants]
 
Female   9 
Male   23 
Region of Enrollment 
[Units: Participants]
 
United States   32 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery.   [ Time Frame: up to 28 days following transplant ]

2.  Secondary:   Days Until Platelet Recovery   [ Time Frame: up to 28 days following transplant ]

3.  Secondary:   CD34+ Cell Collection Efficiency.   [ Time Frame: up to 7 days ]

4.  Secondary:   Mononuclear Cel (MNC) Collection Efficiency   [ Time Frame: up to 7 days ]

5.  Secondary:   Platelet Collection Efficiency   [ Time Frame: up to 7 days ]

6.  Secondary:   Hematocrit of MNC Product   [ Time Frame: 7 days ]

7.  Secondary:   Granulocyte % of MNC Product   [ Time Frame: 7 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jerome R Bill, M.D.
Organization: Terumo BCT
phone: 303-231-4729
e-mail: jerry.bill@terumobct.com



Responsible Party: Terumo BCT
ClinicalTrials.gov Identifier: NCT01292486     History of Changes
Other Study ID Numbers: BCT10-02
First Submitted: February 2, 2011
First Posted: February 9, 2011
Results First Submitted: September 14, 2012
Results First Posted: May 1, 2013
Last Update Posted: May 1, 2013