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)
Enter a location and click search to find clinical trials sorted by distance.
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