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Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection

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ClinicalTrials.gov Identifier: NCT01095757
Recruitment Status : Completed
First Posted : March 30, 2010
Results First Posted : September 12, 2014
Last Update Posted : September 29, 2014
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Edmund Waller, Emory University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Myeloma
Lymphoma
Intervention Drug: Plerixafor
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Plerixafor + Chemo and G-CSF
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Patients who receive a combination of Plerixafor, chemotherapy and granulocyte-colony stimulating factor (G-CSF).

Plerixafor : 240 µg/kg subcutaneous injection on the day that the absolute neutrophil count (ANC) is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target cluster of differentiation 34 (CD34) cell dose has been reached.

Period Title: Overall Study
Started 45
Completed 45
Not Completed 0
Arm/Group Title Plerixafor + Chemo and G-CSF
Hide Arm/Group Description

Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.

Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.

Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 45 participants
Multiple Myeloma (MM), n = 17
58
(33 to 72)
Lymphoma, n = 28
56
(38 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
15
  33.3%
Male
30
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   4.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
14
  31.1%
White
29
  64.4%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants
45
1.Primary Outcome
Title Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis
Hide Description [Not Specified]
Time Frame Within the first 4 days following the first dose of Plerixafor
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Multiple Myeloma Lymphoma
Hide Arm/Group Description:

Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.

Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.

Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.

Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.

Overall Number of Participants Analyzed 10 23
Measure Type: Number
Unit of Measure: participants
9 17
2.Primary Outcome
Title Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg
Hide Description [Not Specified]
Time Frame Within the first 4 days following the first dose of Plerixafor
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Multiple Myeloma Lymphoma
Hide Arm/Group Description:

Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.

Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.

Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.

Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.

Overall Number of Participants Analyzed 10 23
Measure Type: Number
Unit of Measure: participants
10 23
3.Secondary Outcome
Title Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500)
Hide Description [Not Specified]
Time Frame Within the first 4 days following the first dose of Plerixafor
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Multiple Myeloma Lymphoma
Hide Arm/Group Description:

Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.

Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.

Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.

Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.

Overall Number of Participants Analyzed 10 23
Mean (Standard Deviation)
Unit of Measure: days
12.4  (1.62) 12.105  (1.63)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Plerixafor + Chemo and G-CSF
Hide Arm/Group Description

Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.

Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.

All-Cause Mortality
Plerixafor + Chemo and G-CSF
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Plerixafor + Chemo and G-CSF
Affected / at Risk (%)
Total   0/45 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Plerixafor + Chemo and G-CSF
Affected / at Risk (%)
Total   29/45 (64.44%) 
Blood and lymphatic system disorders   
Hypokalemia  8/45 (17.78%) 
Thrombocytopenia Grade 1/2  26/45 (57.78%) 
Thrombocytopenia Over Grade 2  17/45 (37.78%) 
Anemia  1/45 (2.22%) 
Gastrointestinal disorders   
Nausea  13/45 (28.89%) 
Diarrhea  12/45 (26.67%) 
General disorders   
Fatigue  11/45 (24.44%) 
Lightheadedness  7/45 (15.56%) 
Headache  6/45 (13.33%) 
Musculoskeletal and connective tissue disorders   
Bone Pain  12/45 (26.67%) 
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. Edmund Waller
Organization: Winship Cancer Institute Emory University
Phone: 404-727-4995
EMail: ewaller@emory.edu
Publications:
Layout table for additonal information
Responsible Party: Edmund Waller, Emory University
ClinicalTrials.gov Identifier: NCT01095757    
Other Study ID Numbers: IRB00027735
WCI1671-09 ( Other Identifier: Other )
First Submitted: March 26, 2010
First Posted: March 30, 2010
Results First Submitted: October 22, 2013
Results First Posted: September 12, 2014
Last Update Posted: September 29, 2014