NCT00555100

Safety Study of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	lenalidomide	10mg-25mg PO/day,day1-day21 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops.
DRUG	dexamethasone	40mg PO/day, day1-4,9-12,17-20 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops.

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2007-11-07
• Last updated: 2019-11-12

Locations

5 sites across 1 country: Japan