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
The purpose of this study is to test whether the addition of the drug plerixafor to treatment with chemotherapy and G-CSF can better activate your bone marrow stem cells to improve the chances of transplant. The study will look for the activation of a certain type of blood cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and G-CSF. The investigators will follow the number of patients that achieve the target numbers of CD34+ cells. The number of patients achieving the target level of CD34+ cells, and the total number of CD34+ cells, will be compared to the numbers in previous studies testing just chemotherapy and G-CSF, without plerixafor.
The investigators will also test the safety of the combination of plerixafor with chemotherapy and G-CSF and look at the success of the transplantation after 12 months.
|Condition or disease||Intervention/treatment||Phase|
|Myeloma Lymphoma||Drug: Plerixafor||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Plerixafor (Mozobil ™, AMD3100) in Combination With Chemotherapy and G-CSF for CD34+ Cell Mobilization|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||February 2014|
Plerixafor + Chemo and G-CSF
Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.
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 CD34 cell dose has been reached.
- Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis [ Time Frame: Within the first 4 days following the first dose of Plerixafor ]
- Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg [ Time Frame: Within the first 4 days following the first dose of Plerixafor ]
- Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500) [ Time Frame: Within the first 4 days following the first dose of Plerixafor ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095757
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Edmund Waller, MD, PhD||Emory University Winship Cancer Institute|