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

NCT02078102 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IUCRO-0419CA1829471312925163
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma; Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• Percent of Patients Who Mobilize and Collect at Least Half of the Total Target CD34+ Cell Dose in the First Apheresis

  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.

  within 100 days of transplant

Secondary Outcomes (4)

• Number of Patients With Treatment Related Adverse Events Grade 3 or Higher for Nonhematological Toxicity

  within 100 days of transplant

• Summary Statistics for Graft Composition of Peripheral Blood Stem Cell Collection at Each Time Point

  Cycle 2, Days 1-4, within 100 days of transplant

• Time to Neutrophil Engraftment

  within 100 days of transplant

• Time to Platelet Engraftment

  within 100 days of transplant

Study Arms (1)

Treatment

OTHER

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.

Drug: Meloxicam; Drug: Filgrastim

Interventions

Meloxicam DRUG

15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.

Also known as: Mobic

Treatment

Filgrastim DRUG

Filgrastim will be subcutaneously injected in one or two sites at home.

Also known as: Neupogen

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sherif S. Farag: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• 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.

  PMID: 34510361 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma, Non-Hodgkin

Interventions

Meloxicam; Filgrastim

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Dr. Sherif Farag
• Organization: IndianaU

ssfarag@iu.edu

(317) 278-0460

Study Officials

• Sherif Farag, M.D., Ph.D.

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: March 5, 2014
• Study Start: March 11, 2014
• Primary Completion: November 6, 2018
• Study Completion: February 21, 2019
• Last Updated: February 21, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-02

Locations

US (1)