A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma
Condition: Multiple Myeloma; Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Lymphoma, Non-Hodgkin
Intervention: Meloxicam; Filgrastim
Intervention description: 15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.; Filgrastim will be subcutaneously injected in one or two sites at home.
Intervention MeSH terms: Meloxicam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

        A patient must meet all of the following inclusion criteria to be eligible for enrollment
        in this study:

          1. Has provided written informed consent prior to completing any study procedures.

          2. 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.

               1. Multiple myeloma should be in first or second partial response or better, as
                  defined by International Myeloma Working Group criteria.50

               2. 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

          3. Age ≥18 to ≤75 years at time of consent.

          4. Karnofsky performance status of at least 70%.

          5. Adequate organ function defined as:

               1. Left ventricular ejection fraction ≥45%

               2. Corrected DLCO ≥50%

               3. Serum bilirubin, AST (aspartate aminotransferase) and ALT(alanine
                  aminotransferase) ≤ twice the upper limit of normal

               4. Serum creatinine ≤ 2.0 mg/dl

               5. Urine M-protein ≤1 g/24 hours (MM patients only)

          6. No prior attempt at mobilizing PBSC.

          7. 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.

          8. 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.

          9. Patients must be negative for HIV.

         10. Women of childbearing potential must have a negative pregnancy test (urine or serum)
             and must not be lactating at the time of informed consent.

               1. 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:

          1. 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).

          2. Patients must not have active central nervous system involvement.

          3. Patients must not have a prior autologous, syngeneic or allogeneic hematopoietic stem
             cell transplant.

          4. Patients must not have received prior bone seeking radionuclides.

          5. Patients must not have received myeloid growth factors within 2 weeks before
             mobilization attempt on this study.

          6. Patients must not have taken nonsteroidal antiinflammatory drugs (NSAID) in the past
             14 days before treatment on this protocol.

          7. 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.

          8. Patients with a history of asthma will be excluded because of the potential for NSAID
             to precipitate asthma in these patients.