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Status:

TERMINATED

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

Lead Sponsor:

Cephalon

Conditions:

Multiple Myeloma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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)

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

February 1 2002

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT00293111

Start Date

February 1 2002

Last Update

May 12 2014

Active Locations (8)

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Page 1 of 2 (8 locations)

1

H. Lee Moffitt Cancer Center

Tampa, Florida, United States, 33612

2

Emory University School of Medicine

Atlanta, Georgia, United States, 30322

3

Johns Hopkins School of Medicine

Baltimore, Maryland, United States, 21231

4

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263