A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma

Inclusion criteria

A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:

• 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:

• Diffuse large B cell lymphoma
• Transformed lymphoma
• Mantle cell lymphoma
• Follicular lymphoma (any grade)
• Peripheral T cell lymphoma
• 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%
• Corrected DLCO ≥50%
• Serum bilirubin, AST (aspartate aminotransferase) and ALT(alanine aminotransferase) ≤ twice the upper limit of normal
• Serum creatinine ≤ 2.0 mg/dl
• Urine M-protein ≤1 g/24 hours (MM patients only)
• No prior attempt at mobilizing PBSC.
• Patients must be at least 4 weeks from last cytotoxic chemotherapy (including alkylating, anthracyclines, epipodophylatoxins, and platinum drugs), or immunomodulatory drugs (including lenalidomide or pomalidomide, or related derivatives) at time of treatment on this protocol.
• Patients must be at least 2 weeks from last treatment with a proteasome inhibitor (e.g., bortezomib, carfilzomib) at time of treatment on this protocol.
• Patients must be negative for HIV.
• Women of childbearing potential must have a negative pregnancy test (urine or serum) and must not be lactating at the time of informed consent.

• Women and men must use adequate birth control while taking part in this study (such as a condom or diaphragm with contraceptive cream/jelly, birth control pills, Norplant, abstinence (no sexual intercourse) or surgical sterilization.

Exclusion criteria

Exclude a patient if any of the following conditions are observed:

• 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.

a) Patients with active significant symptoms of dyspepsia will be excluded.

• Patients with a history of asthma will be excluded because of the potential for NSAID to precipitate asthma in these patients.