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Collection of Transplant Stem Cells for Plasma Cell Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01547806
First Posted: March 8, 2012
Last Update Posted: July 31, 2017
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):
Daniel Fowler, M.D., National Institutes of Health Clinical Center (CC)
Results First Submitted: June 22, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Plasma Cell Myeloma
Multiple Myeloma
Interventions: Drug: Filgrastim
Drug: Plerixafor
Procedure: Apheresis

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Our study was a relatively small pilot study, with the primary emphasis being on expanding standard stem cell therapy options for patients with multiple myeloma. The plerixafor plus G-CSF combination is used relatively ubiquitously, and several larger studies relating to plerixafor have been performed at large centers that treat multiple myeloma.

Reporting Groups
  Description
Hematopoietic Progenitor Cells (HPC)

Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.

Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days

Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight

Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 10^6 CD34+ cells/kg.


Participant Flow:   Overall Study
    Hematopoietic Progenitor Cells (HPC)
STARTED   49 
COMPLETED   49 
NOT COMPLETED   0 



  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
Hematopoietic Progenitor Cells (HPC)

Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.

Filgrastim: Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days

Plerixafor: Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight

Apheresis: The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106^ CD34+ cells/kg.


Baseline Measures
   Hematopoietic Progenitor Cells (HPC) 
Overall Participants Analyzed 
[Units: Participants]
 49 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      40  81.6% 
>=65 years      9  18.4% 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.99  (8.45) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      23  46.9% 
Male      26  53.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      48  98.0% 
Unknown or Not Reported      1   2.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      1   2.0% 
Asian      1   2.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      7  14.3% 
White      40  81.6% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   49 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Patients Achieving at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight on Day 1 of Apheresis   [ Time Frame: Day 1 of apheresis ]

2.  Primary:   Percentage of Patients Requiring 2 Days to Achieve at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight   [ Time Frame: Through Day 2 of collection ]

3.  Primary:   Average Number of Cluster of Differentiation 34 (CD34) Cells Collected (Per kg Recipient Body Weight (BW))   [ Time Frame: Through Day 2 of collection ]

4.  Primary:   Median and Standard Deviation of Cluster of Differentiation 34 (CD34) Cells Collected (Per Kg Recipient Body Weight) (BW)   [ Time Frame: Through Day 2 of collection ]

5.  Primary:   Range of Cluster of Differentiation 34 (CD34) Cells Collected   [ Time Frame: Through Day 2 of collection ]

6.  Primary:   25th and 75th Percentile Values of Cluster of Differentiation 34 (CD34) Cells Collected   [ Time Frame: Through Day 2 of collection ]

7.  Primary:   Number of Hematopoietic Progenitor Cell (HPC) Apheresis Products Collected and Cryopreserved for Subsequent Use in Autologous Hematopoietic Cell Transplantation (AHCT) in Subjects With Plasma Cell Myeloma (PCM)   [ Time Frame: Indefinitely until a referring physician requests the product for standard clinical care or until product(s) is no longer needed and disposed of ]

8.  Secondary:   Number of Participants With Serious and Non-Serious Adverse Events   [ Time Frame: 27 months and 27 days ]

9.  Secondary:   Percentage of Patients That Required Plerixafor + Granulocyte-colony Stimulating Factor (G-CSF) And Only G-CSF (no Plerixafor)   [ Time Frame: One week of mobilization therapy ]

10.  Secondary:   Percentage of Patients That Achieved or Did Not Achieve 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg   [ Time Frame: Through Day 2 of collection ]

11.  Secondary:   Percentage of Patients That Achieved ≥ 2 x 10^6 But Less Than 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg (Day One Collection)   [ Time Frame: Day one of collection ]

12.  Secondary:   Degree of Tumor Cell Contamination in the Final Product   [ Time Frame: Day 1 of apheresis ]

13.  Secondary:   Impact of Plerixafor in the Degree of Tumor Cell Contamination in the Final Product   [ Time Frame: Day 1 of apheresis ]


  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
The sample size in outcome measure number 6 was inadequate. Results were not conclusive and the information is determined to be too preliminary to present. No conclusion should be drawn from the reported data for this outcome.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Daniel H. Fowler
Organization: National Cancer Institute
phone: 240-760-6164
e-mail: dhfowler@helix.nih.gov


Publications:

Responsible Party: Daniel Fowler, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01547806     History of Changes
Other Study ID Numbers: 120074
12-C-0074
First Submitted: March 6, 2012
First Posted: March 8, 2012
Results First Submitted: June 22, 2017
Results First Posted: July 31, 2017
Last Update Posted: July 31, 2017



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