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

NCT02078102 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-02-21

Study results available
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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

Interventions

DRUG

Meloxicam

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

DRUG

Filgrastim

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Sherif S. Farag

    lead OTHER

Principal Investigators

  • Sherif Farag, M.D., Ph.D. · Indiana University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-11
Primary Completion
2018-11-06
Completion
2019-02-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02078102 on ClinicalTrials.gov