Safety and Efficacy of SDX-101 (R-Etodolac) in Patients With Relapsed or Refractory Multiple Myeloma (MM)
This study has been terminated.
First Posted: February 17, 2006
Last Update Posted: May 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
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)
Drug: SDX-101 (R-Etodolac)
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
||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)
| Estimated Enrollment:
| Study Start Date:
| Primary Completion Date:
||October 2003 (Final data collection date for primary outcome measure)
Information from the National Library of Medicine
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|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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
- 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:
• Disease progression developed following the achievement of at least stable disease or better to an anti-myeloma regimen.
• 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.
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00293111
|H. Lee Moffitt Cancer Center
|Tampa, Florida, United States, 33612 |
|Emory University School of Medicine
|Atlanta, Georgia, United States, 30322 |
|Johns Hopkins School of Medicine
|Baltimore, Maryland, United States, 21231 |
|Roswell Park Cancer Institute
|Buffalo, New York, United States, 14263 |
|University of North Carolina at Chapel Hill
|Chapel Hill, North Carolina, United States, 27599 |
|Cleveland Clinic Foundation
|Cleveland, Ohio, United States, 44195 |
|University of Pittsburgh Cancer Institute
|Pittsburgh, Pennsylvania, United States, 15232 |
|MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
History of Changes
|Other Study ID Numbers:
||February 16, 2006
||February 17, 2006
|Last Update Posted:
||May 12, 2014
Keywords provided by Teva Pharmaceutical Industries ( Cephalon ):
Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Additional relevant MeSH terms:
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Cyclooxygenase 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs