A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT02078102|
Recruitment Status : Completed
First Posted : March 5, 2014
Results First Posted : February 21, 2021
Last Update Posted : February 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Non-Hodgkin's Lymphoma||Drug: Meloxicam Drug: Filgrastim||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Prostaglandin E2 Inhibition, Using Meloxicam, Plus Filgrastim for Mobilization of Autologous Peripheral Blood Stem Cells in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma|
|Actual Study Start Date :||March 11, 2014|
|Actual Primary Completion Date :||November 6, 2018|
|Actual Study Completion Date :||February 21, 2019|
Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.
15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.
10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.
15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
Other Name: Mobic
Filgrastim will be subcutaneously injected in one or two sites at home.
Other Name: Neupogen
- Percent of Patients Who Mobilize and Collect at Least Half of the Total Target CD34+ Cell Dose in the First Apheresis [ Time Frame: within 100 days of transplant ]
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.
- Number of Patients With Treatment Related Adverse Events Grade 3 or Higher for Nonhematological Toxicity [ Time Frame: within 100 days of transplant ]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.
- Summary Statistics for Graft Composition of Peripheral Blood Stem Cell Collection at Each Time Point [ Time Frame: Cycle 2, Days 1-4, within 100 days of transplant ]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 to Neutrophil Engraftment [ Time Frame: within 100 days of transplant ]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 to Platelet Engraftment [ Time Frame: within 100 days of transplant ]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.
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): NCT02078102
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Sherif Farag, M.D., Ph.D.||Indiana University|