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

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ClinicalTrials.gov Identifier: NCT02078102
Recruitment Status : Completed
First Posted : March 5, 2014
Results First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sherif S. Farag, Indiana University School of Medicine

Tracking Information
First Submitted Date  ICMJE February 20, 2014
First Posted Date  ICMJE March 5, 2014
Results First Submitted Date  ICMJE January 13, 2021
Results First Posted Date  ICMJE February 21, 2021
Last Update Posted Date February 21, 2021
Actual Study Start Date  ICMJE March 11, 2014
Actual Primary Completion Date November 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2021)
Percent of Patients Who Mobilize and Collect at Least Half of the Total Target CD34+ Cell Dose in the First Apheresis [ Time Frame: within 100 days of transplant ]
Percent of patients who mobilize and collect at least half of the total target CD34+ cell dose in the first apheresis with binomial exact confidence intervals according to disease: Multiple myeloma patients: percent of patients with >= 5x106 CD34 cells/kg in the first day's apheresis. Non-Hodgkin's lymphoma patients: percent of patients with >= 2.5x106 CD34 cells/kg in the first day's apheresis.
Original Primary Outcome Measures  ICMJE
 (submitted: March 3, 2014)
Number of patients who mobilize and collect at least half of the total target CD34+ cell dose in the first apheresis [ Time Frame: 4 years ]
The objective of this study is to investigate whether meloxicam and filgrastim can result in a 20% increase in the proportion of patients who mobilize and collect at least half of the total target CD34+ cell dose in the first apheresis. As the total target CD34 dose varies with disease, the primary objective will be as follows according to disease: • Multiple myeloma patients: Investigate if meloxicam and filgrastim can result in an increase in the proportion of patients who mobilize and collect ≥5x106 CD34 cells/kg in the first day's apheresis, from a historical 40% to at least 60%. • Non-Hodgkin's lymphoma patients: Investigate if meloxicam and filgrastim can result in an increase in the proportion of patients who mobilize and collect ≥2.5x106 CD34 cells/kg in the first day's apheresis, from a historical 50% to at least 70%.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2021)
  • Number of Patients With Treatment Related Adverse Events Grade 3 or Higher for Nonhematological Toxicity [ Time Frame: within 100 days of transplant ]
    Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
  • Summary Statistics for Graft Composition of Peripheral Blood Stem Cell Collection at Each Time Point [ Time Frame: Cycle 2, Days 1-4, within 100 days of transplant ]
    Mean and Standard Deviation of the Graft Composition of Peripheral Blood Stem Cell Collection (CD34 (x10^6cells/kg)) at each time point collected during Cycle 2.
  • Time to Neutrophil Engraftment [ Time Frame: within 100 days of transplant ]
    Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. The median and 95% confidence intervals will be provided. Only patients with neutrophil engraftment will be included.
  • Time to Platelet Engraftment [ Time Frame: within 100 days of transplant ]
    Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive Complete Blood Counts (CBCs) obtained on different days after transplantation during which the platelet count is at least 20 x109/l. The CBCs obtained should be at least seven days after the most recent platelet transfusion. The median and 95% confidence intervals will be provided. Only patients achieving platelet engraftment will be included.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2014)
  • Toxicity Profile of Meloxicam and Filgrastim [ Time Frame: 4 years ]
    Describe the toxicity profile of the combination of Meloxicam and Filgrastim
  • Graft Composition of Peripheral Blood Stem Cell Collection [ Time Frame: 4 years ]
    Describe the graft composition of PBSC collected using Meloxicam and Filgrastim including hematopoietic and immune cell subsets.
  • Engraftment Kinetics of Meloxicam and Filgrastim [ Time Frame: 4 years ]
    Describe the engraftment kinetics of Meloxicam and Filgrastim mobilized PBSC in MM and NHL patients undergoing myeloablative autologous PBSC transplantation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Myeloma
  • Non-Hodgkin's Lymphoma
Intervention  ICMJE
  • Drug: Meloxicam
    15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
    Other Name: Mobic
  • Drug: Filgrastim
    Filgrastim will be subcutaneously injected in one or two sites at home.
    Other Name: Neupogen
Study Arms  ICMJE Treatment

Meloxicam and Filgrastim will be administered in fixed doses to each patient enrolled on this study. The treatments will be administered in a staggered dose schedule for a total treatment duration of 7 days prior to apheresis.

15 mg tablets of Meloxicam will be taken orally for 5 consecutive days.

10 µg/kg of Filgrastim will be subcutaneously injected for 5 consecutive days. Filgrastim may be subcutaneously injected for an additional 3 days if patients do not meet the primary endpoint for cell collection.

Interventions:
  • Drug: Meloxicam
  • Drug: Filgrastim
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2021)
38
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2014)
32
Actual Study Completion Date  ICMJE February 21, 2019
Actual Primary Completion Date November 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02078102
Other Study ID Numbers  ICMJE IUCRO-0419
CA182947 ( Other Grant/Funding Number: NCI )
1312925163 ( Other Identifier: Indiana University IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sherif S. Farag, Indiana University School of Medicine
Study Sponsor  ICMJE Sherif S. Farag
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Sherif Farag, M.D., Ph.D. Indiana University
PRS Account Indiana University
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP