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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Brigham and Women's Hospital Massachusetts General Hospital Celgene Corporation Millennium Pharmaceuticals, Inc. |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00378209 |
The purpose of this study is to evaluate the effectiveness and side effects of the bortezomib, lenalidomide and dexamethasone combination in relapsed or relapsed and refractory multiple myeloma. Each of these drugs are approved by the U.S Food and Drug Administration, but have not been approved in the combination for treating patients in this setting.
Condition | Intervention | Phase |
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Multiple Myeloma |
Drug: Bortezomib Drug: Lenalidomide Drug: Dexamethasone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Am Open-Label Phase II Study of the Safety and Efficacy of Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma |
Estimated Enrollment: | 64 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2009 (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:
Exclusion Criteria:
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Paul Richardson, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( Paul Richardson, MD ) |
Study ID Numbers: | 06-147 |
Study First Received: | September 18, 2006 |
Last Updated: | April 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00378209 History of Changes |
Health Authority: | United States: Food and Drug Administration |
relapsed multiple myeloma refractory multiple myeloma |
Anti-Inflammatory Agents Dexamethasone Immunoproliferative Disorders Antineoplastic Agents, Hormonal Blood Protein Disorders Hematologic Diseases Hormone Antagonists Blood Coagulation Disorders Bortezomib Hormones, Hormone Substitutes, and Hormone Antagonists Lenalidomide Vascular Diseases |
Antiemetics Paraproteinemias Hemostatic Disorders Hormones Glucocorticoids Protease Inhibitors Multiple Myeloma Hemorrhagic Disorders Peripheral Nervous System Agents Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Dexamethasone Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Dexamethasone acetate |
Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Bortezomib Gastrointestinal Agents Vascular Diseases Lenalidomide Enzyme Inhibitors Glucocorticoids Pharmacologic Actions Protease Inhibitors Multiple Myeloma Neoplasms |