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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
Enrollment 40
Recruitment Details Forty (40) participants were recruited at Mayo Clinic (Rochester, Florida and Arizona) between December 2009 and October 2011.
Pre-assignment Details One participant was deemed ineligible and is excluded from all analyses per study design.
Arm/Group Title Plerixafor
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 39
Completed 39
Not Completed 0
Arm/Group Title Plerixafor
Hide Arm/Group Description

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

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

Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 39 participants
60
(28 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
14
  35.9%
Male
25
  64.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants
39
1.Primary Outcome
Title Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis
Hide Description

Number of CD34 cells/kg collected on days 1-2.

Apheresis is the process when blood is taken out through a catheter in a vein in one arm, blood is sent through a machine that takes out the stem cells and the rest of the blood is then returned through a vein in your other arm.

Time Frame After 2 days of apheresis
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plerixafor
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: participants
38
2.Secondary Outcome
Title CD34 Yield on Day 1
Hide Description Number of CD34 cells/kg collected on day 1.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plerixafor
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 39
Median (Full Range)
Unit of Measure: cells/kg
3870000
(670000 to 9160000)
3.Secondary Outcome
Title CD34 Yield Day 2
Hide Description Number of CD34 cells/kg collected on day 2
Time Frame Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plerixafor
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 39
Median (Full Range)
Unit of Measure: cells/kg
3550000
(470000 to 9170000)
4.Secondary Outcome
Title Median Number of Days of Apheresis
Hide Description [Not Specified]
Time Frame Duration of apheresis (up to 7 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plerixafor
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 39
Median (Full Range)
Unit of Measure: days
4
(2 to 5)
5.Secondary Outcome
Title Time to Reach 6 Million CD34 Cells
Hide Description Number (median and 95% confidence interval) of days to reach 6 million CD34 cells/kg was estimated using the Kaplan Meier method. Participants were lower than 6 million CD34 cells/kg at time of last follow-up will be censored at that date.
Time Frame Duration of apheresis (up to 7 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plerixafor
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 39
Median (95% Confidence Interval)
Unit of Measure: days
5
(5 to 6)
6.Secondary Outcome
Title Rate of Failure to Mobilize
Hide Description The rate of failure to mobilize will be estimated by dividing the number of patients that fail to mobilize by the total number of evaluable patients. A patient is considered a failure if they never achieve 2.5 million CD34 cells/kg.
Time Frame Duration of apheresis (up to 7 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plerixafor
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3
(.006 to 13)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Plerixafor
Hide Arm/Group Description

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

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

All-Cause Mortality
Plerixafor
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Plerixafor
Affected / at Risk (%) # Events
Total   0/39 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Plerixafor
Affected / at Risk (%) # Events
Total   25/39 (64.10%)    
Blood and lymphatic system disorders   
Anemia  1  1/39 (2.56%)  1
Gastrointestinal disorders   
Abdominal pain  1  7/39 (17.95%)  7
Bloating  1  1/39 (2.56%)  1
Diarrhea  1  10/39 (25.64%)  10
Nausea  1  17/39 (43.59%)  17
General disorders   
Injection site reaction  1  2/39 (5.13%)  2
Investigations   
Platelet count decreased  1  2/39 (5.13%)  2
Nervous system disorders   
Dizziness  1  8/39 (20.51%)  8
Headache  1  8/39 (20.51%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Shaji Kumar
Organization: Mayo Clinic
EMail: kumar.shaji@mayo.edu
Layout table for additonal information
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