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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	24 October 2016
Main ID:	NCT00779922
Date of registration:	23/10/2008
Prospective Registration:	Yes
Primary sponsor:	Poitiers University Hospital
Public title:	Pharmacokinetics of Lenalidomide (Revlimid®) in Patients With Multiple Myeloma and Impaired Renal Function
Scientific title:
Date of first enrolment:	November 2008
Target sample size:	39
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00779922
Study type:	Interventional
Study design:	Endpoint Classification: Pharmacokinetics Study
Phase:	Phase 2

Countries of recruitment
France

Contacts

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Impaired Renal Function

Multiple Myeloma

Intervention(s)

Drug: lenalidomide

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

REVIR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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