Clinical trial NCT02078102: A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Non-Hodgkin's Lymphoma
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-03-05
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Percent of Patients Who Mobilize and Collect at Least Half of the Total Target CD34+ Cell Dose in the First Apheresis
timeFrame: within 100 days of transplant
Secondary outcomes:
measure: Number of Patients With Treatment Related Adverse Events Grade 3 or Higher for Nonhematological Toxicity
timeFrame: within 100 days of transplant
measure: Summary Statistics for Graft Composition of Peripheral Blood Stem Cell Collection at Each Time Point
timeFrame: Cycle 2, Days 1-4, within 100 days of transplant
measure: Time to Neutrophil Engraftment
timeFrame: within 100 days of transplant
measure: Time to Platelet Engraftment
timeFrame: within 100 days of transplant
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Sherif Farag, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patterson AM, Zhang S, Liu L, Li H, Singh P, Liu Y, Farag SS, Pelus LM. Meloxicam with Filgrastim may Reduce Oxidative Stress in Hematopoietic Progenitor Cells during Mobilization of Autologous Peripheral Blood Stem Cells in Patients with Multiple Myeloma. Stem Cell Rev Rep. 2021 Dec;17(6):2124-2138. doi: 10.1007/s12015-021-10259-y. Epub 2021 Sep 12.