Multiple Myeloma Clinical Trial
Official title:
Treatment With Plerixafor in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients to Increase the Number of Peripheral Blood Stem Cells When Given With A Mobilizing Regimen of Chemotherapy and G-CSF
Verified date | February 2014 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if it can increase the circulating levels of peripheral blood stem cells (PBSCs) by ≥ 2-fold before apheresis, and if transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).
Status | Completed |
Enrollment | 40 |
Est. completion date | July 2006 |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Indiana Blood and Marrow Transplantation | Beech Grove | Indiana |
United States | City of Hope National Medical Center | Duarte | California |
United States | Oregon Health and Science University | Portland | Oregon |
United States | University of Rochester Medical Center | Rochester | New York |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Genzyme, a Sanofi Company |
United States,
Dugan MJ, Maziarz RT, Bensinger WI, Nademanee A, Liesveld J, Badel K, Dehner C, Gibney C, Bridger G, Calandra G. Safety and preliminary efficacy of plerixafor (Mozobil) in combination with chemotherapy and G-CSF: an open-label, multicenter, exploratory tr — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant | Safety assessment was based on the incidence of adverse event reports. Participant count of AEs (Adverse Events) by severity and by relationship to study drug. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment. | 13 months | Yes |
Secondary | Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL | The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL). | Days 4-5 (first dose of plerixafor to apheresis) | No |
Secondary | Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant | Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment. | 2 months | No |
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