Home
Search
Study Topics
Glossary
|
Study 18 of 872 for search of: | "Paraproteinemias" |
Previous Study | Return to Search Results | Next Study |
|
|
|
|
|
Sponsored by: |
Celgene Corporation |
---|---|
Information provided by: | Celgene Corporation |
ClinicalTrials.gov Identifier: | NCT00555100 |
CC-5013-MM-017 is a Phase I, multicenter study to determine the maximum tolerated dose (MTD), safety profile, pharmacokinetics, and preliminary efficacy of lenalidomide with and without dexamethasone in Japanese subjects with previously treated MM. The study will consist of two cohorts: 1) Monotherapy "Maximum Tolerated Dose (MTD) Determination" Cohort; and 2) "Combination Treatment" Cohort.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: lenalidomide Drug: dexamethasone |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Multicenter, Phase I Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Efficacy of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma |
Estimated Enrollment: | 15 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Absolute neutrophil count (ANC) < 1,000cells/mL Platelet count < 75,000/mL Serum creatinine > 2.5 mg/dL Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
Japan | |
Niigata Cancer Center Hospital | |
Niigata, Japan | |
Keio University Hospital | |
Tokyo, Japan | |
Japan, Aichi | |
National Hospital Organization Nagoya Medical Center | |
Nagoya, Aichi, Japan | |
Nagoya City University Hospital | |
Nagoya, Aichi, Japan | |
Japan, Tochigi | |
Jichi Medical University Hospital | |
Shimotsuke, Tochigi, Japan |
Study Director: | Masaaki Takatoku, M.D. | Celgene K.K. |
Responsible Party: | Celgene KK ( Joseph Melillo/ President of Celgene KK ) |
Study ID Numbers: | CC-5013-MM-017 |
Study First Received: | November 6, 2007 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00555100 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Dexamethasone Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Lenalidomide Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics |
Hormones Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents Central Nervous System Agents |