Treatment With AMD3100 (Plerixafor) in MM Patients to Mobilize PBCs For Collection and for Transplantation

This study has been terminated.
(Insufficient cell mobilization for tandem transplants)
Sponsor:
Collaborator:
AnorMED
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00396383
First received: November 2, 2006
Last updated: February 10, 2014
Last verified: February 2014
Results First Received: February 11, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Intervention: Drug: plerixafor

  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
Study enrollment began in November 2004 and the study was terminated in May 2007. A total of 20 participants were planned for this study, however the study was terminated early because of insufficient mobilization of CD34+ cells after treatment with plerixafor alone for use in tandem transplants.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Participants With Multiple Myeloma (MM) Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.

Participant Flow:   Overall Study
    Participants With Multiple Myeloma (MM)  
STARTED     9  
COMPLETED     6  
NOT COMPLETED     3  
Death                 2  
Lost to Follow-up                 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.
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Reporting Groups
  Description
Participants With Multiple Myeloma (MM) Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.

Baseline Measures
    Participants With Multiple Myeloma (MM)  
Number of Participants  
[units: participants]
  9  
Age  
[units: years]
Mean ± Standard Deviation
  62.0  ± 8.0  
Gender  
[units: participants]
 
Female     6  
Male     3  



  Outcome Measures
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1.  Primary:   Number of Participants Who Achieved ≥4*10^6 CD34+ Cells/kg   [ Time Frame: Day 1 up to day 4 ]

2.  Primary:   Participant Counts of Summarized Adverse Events (AE) During Treatment   [ Time Frame: 1 month ]

3.  Secondary:   Number of Transplantations That Achieved Polymorphonuclear Leukocyte (PMN) Engraftment Grouped by Days to Engraftment   [ Time Frame: Approximately 2 months ]
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Measure Type Secondary
Measure Title Number of Transplantations That Achieved Polymorphonuclear Leukocyte (PMN) Engraftment Grouped by Days to Engraftment
Measure Description Polymorphonuclear cell (PMN) engraftment was defined as a PMN count ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1*10^9/L for 1 day. Days to engraftment corresponded to the first day that the criteria were met after transplantation.
Time Frame Approximately 2 months  
Safety Issue No  

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.
Intent to treat population includes participants who received plerixafor and underwent transplantation. One participant had two transplants.

Reporting Groups
  Description
Participants With Multiple Myeloma (MM) Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.

Measured Values
    Participants With Multiple Myeloma (MM)  
Number of Participants Analyzed  
[units: participants]
  9  
Number of transplantations Analyzed  
[units: transplantations]
  10  
Number of Transplantations That Achieved Polymorphonuclear Leukocyte (PMN) Engraftment Grouped by Days to Engraftment  
[units: transplantations]
 
<= Day 12 post transplant     10  
Day 13 to 21 post transplant     0  
>= Day 22 post transplant     0  

No statistical analysis provided for Number of Transplantations That Achieved Polymorphonuclear Leukocyte (PMN) Engraftment Grouped by Days to Engraftment



4.  Secondary:   Number of Transplantations That Achieved Platelet (PLT) Engraftment Grouped by Days to Engraftment   [ Time Frame: Approximately 2 months ]

5.  Secondary:   Number of Participants With a Durable Graft at 12 Months Post Transplantation   [ Time Frame: Approximately month 13 ]

6.  Post-Hoc:   Number of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg   [ Time Frame: Day 1 up to day 4 ]


  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
Study had limited enrollment prior to termination.


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