NCT01937442

Pharmacokinetic Study of Thalidomide in Subjects With Multiple Myeloma

A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of Thalidomide Following Multiple Oral Dosing in Subjects With Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Objective of this study is to characterize the steady-state pharmacokinetics (PK) of thalidomide when given orally as monotherapy to subjects with multiple myeloma.

Detailed description

This is an open-label, PK study in multiple myeloma subjects who are currently receiving thalidomide-containing therapy or are newly diagnosed. The study will consist of a screening phase, a baseline phase, a PK phase with a 5-day period of thalidomide treatment (200 mg/day), and an end-of-study evaluation on Day 6. Subjects will have frequent blood samples drawn for PK assessments on Days 5 and 6 in an inpatient setting.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Thalidomide Celgene™	200mg once daily and by mouth

Timeline

• Start date: 2013-11-07
• Primary completion: 2015-09-23
• Completion: 2015-09-23
• First posted: 2013-09-09
• Last updated: 2019-11-12

Locations

7 sites across 2 countries: France, United Kingdom