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Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide and Planning to Undergo Autologous Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT00998049
Recruitment Status : Completed
First Posted : October 20, 2009
Results First Posted : July 30, 2012
Last Update Posted : May 14, 2015
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Multiple Myeloma
Refractory Multiple Myeloma
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Interventions: Drug: plerixafor
Drug: filgrastim

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Forty (40) participants were recruited at Mayo Clinic (Rochester, Florida and Arizona) between December 2009 and October 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant was deemed ineligible and is excluded from all analyses per study design.

Reporting Groups
  Description
Plerixafor

Plerixafor 160mg/kg/dose by IV on days 5-8

Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.


Participant Flow:   Overall Study
    Plerixafor
STARTED   39 
COMPLETED   39 
NOT COMPLETED   0 



  Baseline Characteristics

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
Plerixafor

Plerixafor 160mg/kg/dose by IV on days 5-8

Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.


Baseline Measures
   Plerixafor 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age 
[Units: Years]
Median (Full Range)
 60 
 (28 to 73) 
Gender 
[Units: Participants]
 
Female   14 
Male   25 
Region of Enrollment 
[Units: Participants]
 
United States   39 


  Outcome Measures

1.  Primary:   Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis   [ Time Frame: After 2 days of apheresis ]

2.  Secondary:   CD34 Yield on Day 1   [ Time Frame: Day 1 ]

3.  Secondary:   CD34 Yield Day 2   [ Time Frame: Day 2 ]

4.  Secondary:   Median Number of Days of Apheresis   [ Time Frame: Duration of apheresis (up to 7 days) ]

5.  Secondary:   Time to Reach 6 Million CD34 Cells   [ Time Frame: Duration of apheresis (up to 7 days) ]

6.  Secondary:   Rate of Failure to Mobilize   [ Time Frame: Duration of apheresis (up to 7 days) ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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


Results Point of Contact:  
Name/Title: Dr. Shaji Kumar
Organization: Mayo Clinic
e-mail: kumar.shaji@mayo.edu



Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00998049     History of Changes
Other Study ID Numbers: MC0889
NCI-2009-01328 ( Registry Identifier: NCI-CTRP )
MC0889 ( Other Identifier: Mayo Clinic Cancer Center )
08-005644 ( Other Identifier: Mayo Clinic IRB )
First Submitted: October 19, 2009
First Posted: October 20, 2009
Results First Submitted: June 26, 2012
Results First Posted: July 30, 2012
Last Update Posted: May 14, 2015