A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgki… (NCT02078102) | Clinical Trial Compass
CompletedPhase 2
A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma
United States38 participantsStarted 2014-03-11
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Has provided written informed consent prior to completing any study procedures.
. Patients must have a previously documented histologic diagnosis of multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL), and be eligible to undergo autologous PBSC transplantation on institutional protocols.
. Multiple myeloma should be in first or second partial response or better, as defined by International Myeloma Working Group criteria.50
. Non-Hodgkin's lymphoma must be in either first or second partial response or better and have any one of the following histologies:
. Age ≥18 to ≤75 years at time of consent.
. Karnofsky performance status of at least 70%.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent of Patients Who Mobilize and Collect at Least Half of the Total Target CD34+ Cell Dose in the First Apheresis
. Patients must not have received radiation therapy within the past 4 weeks, and not to more than 20% of hematopoiesis forming bones (spine, pelvis and proximal long bones).
. Patients must not have active central nervous system involvement.
. Patients must not have a prior autologous, syngeneic or allogeneic hematopoietic stem cell transplant.
. Patients must not have received prior bone seeking radionuclides.
. Patients must not have received myeloid growth factors within 2 weeks before mobilization attempt on this study.
. Patients must not have taken nonsteroidal antiinflammatory drugs (NSAID) in the past 14 days before treatment on this protocol.
. Patients must not have nor had active or recent peptic ulcer disease within the past 6 months.
. Patients with a history of asthma will be excluded because of the potential for NSAID to precipitate asthma in these patients.