Filgrastim With or Without Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide

This study has been terminated.
(Slow Accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01301963
First received: February 22, 2011
Last updated: July 7, 2014
Last verified: July 2014
Results First Received: July 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Refractory Multiple Myeloma
Interventions: Drug: plerixafor
Biological: filgrastim

  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
No text entered.

Reporting Groups
  Description
Arm I: Control

Patients receive G-CSF SC QD on days 1-4.

filgrastim: Given SC

Arm II: Experimental

Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.

plerixafor: Given SC

filgrastim: Given SC


Participant Flow:   Overall Study
    Arm I: Control     Arm II: Experimental  
STARTED     5     4  
COMPLETED     5     4  
NOT COMPLETED     0     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.
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Reporting Groups
  Description
Arm I

Patients receive G-CSF SC QD on days 1-4.

filgrastim: Given SC

Arm II

Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.

plerixafor: Given SC

filgrastim: Given SC

Total Total of all reporting groups

Baseline Measures
    Arm I     Arm II     Total  
Number of Participants  
[units: participants]
  5     4     9  
Age  
[units: years]
Mean ± Standard Deviation
  52.40  ± 4.16     56.25  ± 8.18     53.00  ± 6.15  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     5     3     8  
>=65 years     0     1     1  
Gender  
[units: participants]
     
Female     2     1     3  
Male     3     3     6  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     2     0     2  
White     3     4     7  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     5     4     9  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     5     4     9  



  Outcome Measures
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1.  Primary:   Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg   [ Time Frame: In =< 2 days of leukaphereses ]

2.  Secondary:   Percentage of Patients Achieving Target Goal CD34+ Cells Dose   [ Time Frame: In =< 5 days of leukaphereses ]

3.  Secondary:   Compare Hematopoietic Stem Cells/kg Collections Between Different Mobilization Regimens in Those Patients Who Are Crossed Over From One Mobilization Regimen to the Other   [ Time Frame: By day 1 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Compare Days of Apheresis Between Mobilization Groups   [ Time Frame: Day 1 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Compare Need for Hospitalization During Mobilization Between Mobilization Groups   [ Time Frame: Day 1 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Compare Need for Remobilization Between Mobilization Groups   [ Time Frame: Day 1 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Hien Duong, MD
Organization: CCCC
phone: 216-445-5531
e-mail: duongh@ccf.org


No publications provided


Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01301963     History of Changes
Other Study ID Numbers: CASE3A10, NCI-2011-00186
Study First Received: February 22, 2011
Results First Received: July 7, 2014
Last Updated: July 7, 2014
Health Authority: United States: Federal Government