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 : Recruiting
First Posted : March 5, 2014
Last Update Posted : May 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Non-Hodgkin's Lymphoma||Drug: Meloxicam Drug: Filgrastim||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 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|
|Estimated Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||January 1, 2020|
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
- Number of patients who mobilize and collect at least half of the total target CD34+ cell dose in the first apheresis [ Time Frame: 4 years ]
The objective of this study is to investigate whether meloxicam and filgrastim can result in a 20% increase in the proportion of patients who mobilize and collect at least half of the total target CD34+ cell dose in the first apheresis. As the total target CD34 dose varies with disease, the primary objective will be as follows according to disease:
• Multiple myeloma patients: Investigate if meloxicam and filgrastim can result in an increase in the proportion of patients who mobilize and collect ≥5x106 CD34 cells/kg in the first day's apheresis, from a historical 40% to at least 60%.
• Non-Hodgkin's lymphoma patients: Investigate if meloxicam and filgrastim can result in an increase in the proportion of patients who mobilize and collect ≥2.5x106 CD34 cells/kg in the first day's apheresis, from a historical 50% to at least 70%.
- Toxicity Profile of Meloxicam and Filgrastim [ Time Frame: 4 years ]Describe the toxicity profile of the combination of Meloxicam and Filgrastim
- Graft Composition of Peripheral Blood Stem Cell Collection [ Time Frame: 4 years ]Describe the graft composition of PBSC collected using Meloxicam and Filgrastim including hematopoietic and immune cell subsets.
- Engraftment Kinetics of Meloxicam and Filgrastim [ Time Frame: 4 years ]Describe the engraftment kinetics of Meloxicam and Filgrastim mobilized PBSC in MM and NHL patients undergoing myeloablative autologous PBSC transplantation
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
|Contact: Carol Huntley, RNemail@example.com|
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Carol Huntley, RN 317-274-3782 firstname.lastname@example.org|
|Contact: Sherif Farag, MBBS, PhD 317-274-0843 email@example.com|
|Principal Investigator: Sherif Farag, MBBS, PhD|
|Principal Investigator:||Sherif Farag, M.D., Ph.D.||Indiana University|