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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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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
| ClinicalTrials.gov Identifier: | NCT00293111 History of Changes |
| Other Study ID Numbers: | SDX-101-04 |
| Study First Received: | February 16, 2006 |
| Last Updated: | April 19, 2006 |
| Health Authority: | United States: Food and Drug Administration |
|
Multiple Myeloma Relapsed Multiple Myeloma Refractory Multiple Myeloma |
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Etodolac |
Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |