Safety and Efficacy of SDX-101 (R-Etodolac) in Patients With Relapsed or Refractory Multiple Myeloma (MM)

Stopped early · Phase 2

Conditions studied: Multiple Myeloma

In brief

An Open Label, Multi-Center, Phase II Study to Investigate the Safety and Efficacy of SDX-101 (R-Etodolac) in Patients with Relapsed or Refractory Multiple Myeloma (MM)

Key facts

Study ID

NCT00293111

Run by

Cephalon

People needed

30

Starts

2002-02-01

Last updated by the study team

2014-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previously diagnosis of multiple myeloma as determined by any two of the major criteria, or major criteria 1 plus minor criteria b, c, or d, or major criteria 3 plus minor criteria a or c, or minor criteria a, b and c or a, b, and d.
• Major criteria:
• Plasmacytomas on tissue biopsy
• Bone marrow plasmacytomas (>30% plasma cells)
• Monoclonal immunoglobulin spike on serum electrophoresis immunoglobulin G (IgG) >3.5 g/dl or immunoglobulin A (IGA) > 2.0 g/dl; kappa or lambda light chain excretion > 1 g/day on 24 hour urine protein electrophoresis
• Minor criteria:
• Bone marrow plasmacytomas (10 to 30% plasma cells)
• Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
• Lytic bone lesions
• Normal IgM < 50 mg/dl, IgA < 100 mg/dl, or IgG < 600 mg/dl
• Has relapsed or refractory disease as determined by the following:
• Relapsed disease:
• Disease progression developed following the achievement of at least stable disease or better to an anti-myeloma regimen.
• Refractory disease:
• Disease progression developed during therapy with an anti-myeloma regimen prior to the achievement of at least stable disease or better. Includes the development of disease progression during maintenance or consolidation therapy with glucocorticoids or cytotoxic chemotherapy.
• Age > 18 at signing of informed consent.
• ECOG performance status 0-2.
• Renal function 1.5 x upper limit normal (blood urea nitrogen [BUN], serum creatinine
• Liver function ≤ 1.5 times upper limit of normal (total bilirubin, SGOT (AST) and SGPT (ALT) values).
• Female patients of childbearing potential must have a negative pregnancy test (serum -human chorionic gonadotropin, -HCG); men and women of reproductive potential must employ effective contraceptive methods while on study therapy, and for 1 month following completion of treatment.
• Signed IRB-approved informed consent by patient prior to all study related procedures.

You may not qualify if…

• History of a prior malignancy with in the last 3 years with the exception of resected basal cell carcinoma, in situ cervical cancer at any time or other resected malignancies with no evidence of recurrence 5 or more years since diagnosis.
• Patients with a hemoglobin count of < 8.0 g/dl, platelet count of < 50,000 cells/mm3, or an absolute neutrophil count (ANC) of < 1000 cells/mm3.
• Serious infection, medical condition, or psychiatric condition that, in the opinion of the investigator, places the subject at unacceptable risk or might interfere with the achievement of the study objectives.
• Chronic viral infection: positive hepatitis B or hepatitis C serology, known positive for human immunodeficiency virus (HIV) or human T-leukemia/lymphoma virus (HTLV).
• Peptic ulcer disease (PUD) requiring treatment or surgical intervention within the last 2 years.
• The use of steroids or chronic nonsteroidal anti-inflammatory drugs 28 days prior to the initiation of study medication.
• Treatment with chemotherapy for the treatment of multiple myeloma or any investigational agent within 6 weeks of study entry.
• History of allergy to NSAIDs or aspirin-induced asthma.
• Pregnancy or currently breast feeding.

Where it is running

• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Johns Hopkins School of Medicine — Baltimore, Maryland, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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