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Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Terumo BCT
ClinicalTrials.gov Identifier:
NCT01292486
First received: February 2, 2011
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
Results First Received: September 14, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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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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  
Number of Participants  
[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 ]
  Show Outcome Measure 1

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

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

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

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

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

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


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


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


No publications provided


Responsible Party: Terumo BCT
ClinicalTrials.gov Identifier: NCT01292486     History of Changes
Other Study ID Numbers: BCT10-02
Study First Received: February 2, 2011
Results First Received: September 14, 2012
Last Updated: April 24, 2013
Health Authority: United States: Food and Drug Administration