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Sponsored by: |
Cephalon |
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Information provided by: | Cephalon |
ClinicalTrials.gov Identifier: | NCT00293111 |
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) |
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:
Refractory disease:
Exclusion Criteria:
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 |
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 Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Cyclooxygenase Inhibitors Vascular Diseases Paraproteinemias Hemostatic Disorders Multiple Myeloma |
Hemorrhagic Disorders Analgesics, Non-Narcotic Etodolac Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Lymphoproliferative Disorders Neoplasms, Plasma Cell |
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 |