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| Sponsor: | Cephalon |
|---|---|
| Information provided by: | Cephalon |
| ClinicalTrials.gov Identifier: | NCT00293111 |
Purpose
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)
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: SDX-101 (R-Etodolac) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Minor criteria:
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.
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| H. Lee Moffitt Cancer Center | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Emory University School of Medicine | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Maryland | |
| Johns Hopkins School of Medicine | |
| Baltimore, Maryland, United States, 21231 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
More Information
| Study ID Numbers: | SDX-101-04 |
| Study First Received: | February 16, 2006 |
| Last Updated: | April 19, 2006 |
| ClinicalTrials.gov Identifier: | NCT00293111 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Multiple Myeloma Relapsed Multiple Myeloma Refractory Multiple Myeloma |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Hemostatic Disorders Hemorrhagic Disorders Sensory System Agents Therapeutic Uses Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Hematologic Diseases Cyclooxygenase Inhibitors Vascular Diseases Enzyme Inhibitors Pharmacologic Actions Multiple Myeloma Neoplasms Etodolac Analgesics, Non-Narcotic Peripheral Nervous System Agents Lymphoproliferative Disorders Antirheumatic Agents Central Nervous System Agents Neoplasms, Plasma Cell |