Pharmacokinetics of Lenalidomide (Revlimid®) in Patients With Multiple Myeloma and Impaired Renal Function

Phase 2

Completed

• Conditions: Multiple Myeloma; Impaired Renal Function
• Interventions: Drug: lenalidomide

• Registration Number: NCT00779922
• Lead Sponsor: Poitiers University Hospital

Brief Summary

The purpose of this study is to determine the pharmacokinetic profile of Revlimid® in patients presenting with Multiple Myeloma and impaired renal function, the safety of Revlimid® in the enrolled patients population.

and evaluate the efficacy of Revlimid®-Dexamethasone combination in patients presenting MM and impaired renal function at completion of 3 cycles of treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-23
• Study First Submitted QC: 2008-10-23
• Study First Posted: 2008-10-24
• Study Start: 2008-11
• Primary Completion: 2012-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Documented diagnosis of relapsed or refractory multiple myeloma (MM).
• Age > 18 years at the time of signing the informed consent form
• Stable renal function

Exclusion Criteria

• Documented amyloidosis

• Any prior use of Revlimid ®

• Any contraindication to Revlimid ® and especially:

• Lack of acceptable method of birth control for female of childbearing potential (FCPB)

  • Men who don't agree to use condom during the study and 4 weeks after the last study drug intake if their partner is a FCPB.
  • Pregnant or breast feeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 1 to 5	lenalidomide	-

Trial Locations

Locations (1)

Poitiers University Hospital; 🇫🇷 Poitiers, France