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Sponsored by: |
Celgene Corporation |
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Information provided by: | Celgene Corporation |
ClinicalTrials.gov Identifier: | NCT00622336 |
This is an international, multicenter, open-label, single-arm study for advanced Multiple Myeloma patients who had previously taken high-dose dexamethasone alone or thalidomide plus high-dose dexamethasone and developed disease progression or that were unable to tolerate the lowest dosing regimen of thalidomide and/or high-dose dexamethasone without grade 3 or 4 toxicity.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: CC-5013 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open-Label, Single-Arm Study of the Safety and Efficacy of CC-5013 Monotherapy for Subjects With Multiple Myeloma: A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 |
Estimated Enrollment: | 700 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
documented disease progression OR inability to tolerate the lowest dosing regimen allowed on previous protocol without a grade 3 or 4 toxicity.
Exclusion Criteria:
Responsible Party: | Celgene Corporation ( Kim Joyce Baez, Manager Clinical Operations ) |
Study ID Numbers: | CC-5013-MM-012 |
Study First Received: | February 14, 2008 |
Last Updated: | February 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00622336 |
Health Authority: | United States: Food and Drug Administration |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Lenalidomide Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Cardiovascular Diseases Pharmacologic Actions |