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
Sherif Farag, MD
Primary Investigator
Overview
The purpose of this trial is 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.
Description
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
You may be eligible for this study if you meet the following criteria:
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Conditions:
Multiple Myeloma,Lymphoma
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Age: Between 18 Years - 100 Years
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Gender: All
Inclusion Criteria
histologic diagnosis of multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL)
eligible to undergo autologous PBSC transplantation on institutional protocols
adequate organ function
no prior attempt at mobilizing PBSC
at least 4 weeks from last cytotoxic chemotherapy or immunomodulatory drugs
at least 2 weeks from last treatment with a proteasome inhibitor
must be negative for HIV
Exclusion Criteria
have received radiation therapy within the past 4 weeks
have active central nervous system involvement
prior autologous, syngeneic or allogeneic hematopoietic stem cell transplant
ave received prior bone seeking radionuclides
have received myeloid growth factors within 2 weeks before mobilization attempt on this study
have taken nonsteroidal antiinflammatory drugs (NSAID) in the past 14 days before treatment on this protocol
have nor had active or recent peptic ulcer disease within the past 6 months
patients with a history of asthma will be excluded because of the potential for NSAID to precipitate asthma in these patients.