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| Sponsor: | Celgene Corporation |
|---|---|
| Information provided by: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00555100 |
Purpose
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: | June 2010 (Final data collection date for primary outcome measure) |
Eligibility| 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)
Contacts and Locations| 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. |
More Information
| 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 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00555100 History of Changes |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
|
Anti-Inflammatory Agents Dexamethasone 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 Vascular Diseases Lenalidomide Gastrointestinal Agents Glucocorticoids Pharmacologic Actions Multiple Myeloma Neoplasms Autonomic Agents Peripheral Nervous System Agents Lymphoproliferative Disorders Central Nervous System Agents |