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

Multiple Myeloma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00779922
• Other study ID #: REVIR
• Status: Completed
• Phase: Phase 2
• First received: October 23, 2008
• Last updated: October 10, 2016
• Start date: November 2008

Study information

• Verified date: October 2016
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : Agence Française de sécurité sanitaire des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Pharmacokinetics Study

Related Conditions & MeSH terms

• Impaired Renal Function
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Renal Insufficiency

Intervention

Drug:
• lenalidomide

Locations

Country	Name	City	State
France	Poitiers University Hospital	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France,