Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients
Lymphoma, Non-Hodgkin, Multiple Myeloma
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Non-Hodgkin's Lymphoma, Multiple Myeloma, Stem cell mobilization
Eligibility Criteria
Inclusion Criteria (Abbreviated List): MM in first partial response/complete response, first relapse, or second partial/complete response NHL in first or second partial or complete remission NHL patients who do not have bone marrow involvement and < 10% for follicular involvement MM patients who have stable disease with < 40% bone marrow involvement No more than three prior regimens of chemotherapy (thalidomide and Decadron are not considered chemotherapy) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 White blood cell count (WBC) >3.0 x 10^9/L Absolute neutrophil count >1.5 x 10^9/L Platelet count >100 x 10^9/L Exclusion Criteria (Abbreviated List): Brain metastases or carcinomatous meningitis Hypercalcaemia [>1 mg/dl above the upper limit of normal (ULN)] Cardiovascular disease that includes proven or predisposition to ventricular arrhythmias Acute Infection
Sites / Locations
- City of Hope National Medical Center
- Indiana Blood and Marrow Transplantation
- University of Rochester Medical Center
- Oregon Health and Science University
- Fred Hutchinson Cancer Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Plerixafor PM
Plerixafor AM
Low CD34+ Count/ Plerixafor PM
Plerixafor After Chemo
Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days. Called 'Cohort A' in protocol, study report and publications.
Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days. Called 'Cohort B' in protocol, study report and publications.
Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days. Called 'Cohort C' in protocol, study report and publications.
This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms. Called 'Investigational Cohort' in protocol, study report and publications.