The trial is an open label Simon optimal two-stage Phase II trial of fixed doses of oral meloxicam and subcutaneous filgrastim to assess the safety and efficacy in mobilizing autologous peripheral blood stem cells (PBSC) from multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) patients planning to undergo high-dose chemotherapy with stem cell support. Clinical data regarding the cellular composition and function of the graft mobilized by this combination will be obtained.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Filgrastim will be subcutaneously injected in one or two sites at home.
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Percent of Patients Who Mobilize and Collect at Least Half of the Total Target CD34+ Cell Dose in the First Apheresis
Percent of patients who mobilize and collect at least half of the total target CD34+ cell dose in the first apheresis with binomial exact confidence intervals according to disease: Multiple myeloma patients: percent of patients with \>= 5x106 CD34 cells/kg in the first day's apheresis. Non-Hodgkin's lymphoma patients: percent of patients with \>= 2.5x106 CD34 cells/kg in the first day's apheresis.
Time frame: within 100 days of transplant
Number of Patients With Treatment Related Adverse Events Grade 3 or Higher for Nonhematological Toxicity
Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time frame: within 100 days of transplant
Summary Statistics for Graft Composition of Peripheral Blood Stem Cell Collection at Each Time Point
Mean and Standard Deviation of the Graft Composition of Peripheral Blood Stem Cell Collection (CD34 (x10\^6cells/kg)) at each time point collected during Cycle 2.
Time frame: Cycle 2, Days 1-4, within 100 days of transplant
Time to Neutrophil Engraftment
Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. The median and 95% confidence intervals will be provided. Only patients with neutrophil engraftment will be included.
Time frame: within 100 days of transplant
Time to Platelet Engraftment
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Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive Complete Blood Counts (CBCs) obtained on different days after transplantation during which the platelet count is at least 20 x109/l. The CBCs obtained should be at least seven days after the most recent platelet transfusion. The median and 95% confidence intervals will be provided. Only patients achieving platelet engraftment will be included.
Time frame: within 100 days of transplant