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Sponsored by: |
Celgene Corporation |
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Information provided by: | Celgene Corporation |
ClinicalTrials.gov Identifier: | NCT00057564 |
Randomized subjects will receive study drug, either thalidomide plus high-dose dexamethasone or placebo identical in appearance to thalidomide plus high-dose dexamethasone, in 4-week cycles. Subjects will remain on study drug until they experience disease progression or until the subject discontinues for any other reason. Subjects will have visits every cycle and all subjects will be followed for survival even after discontinuation from study drug.
Condition | Intervention | Phase |
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Multiple Myeloma |
Drug: Thalidomide and Dexamethasone Drug: Dexamethasone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Parallel-Group, Placebo Controlled, Randomized, Double-Blind Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects With Multiple Myeloma |
Enrollment: | 470 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Thalidomide & Dexamethasone
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Drug: Thalidomide and Dexamethasone
50mg thalidomide
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B: Placebo Comparator
Dexamethasone and placebo
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Drug: Dexamethasone
40mg
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Celgene Corporation ( Deborah Ingenito ) |
Study ID Numbers: | THAL-MM-003 |
Study First Received: | April 4, 2003 |
Last Updated: | March 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00057564 |
Health Authority: | United States: Food and Drug Administration |
Newly Diagnosed Multiple Myeloma Multiple Myeloma |
Dexamethasone Immunoproliferative Disorders Thalidomide Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Anti-Bacterial Agents Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents Neoplasms by Histologic Type |
Immune System Diseases Antineoplastic Agents, Hormonal Growth Substances Gastrointestinal Agents Glucocorticoids Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Leprostatic Agents |