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 range18 Years
SexALL
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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%.
✓. Adequate organ function defined as:
✓. Left ventricular ejection fraction ≥45%
Exclusion criteria
✕. 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.
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