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

This study is not yet open for participant recruitment.

Verified by Poitiers University Hospital, October 2008

Sponsored by:	Poitiers University Hospital
Information provided by:	Poitiers University Hospital
ClinicalTrials.gov Identifier:	NCT00779922

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma Impaired Renal Function	Drug: lenalidomide	Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Pharmacokinetics Study

Further study details as provided by Poitiers University Hospital:

Estimated Enrollment:

Arms	Assigned Interventions
group 1 to 5: Experimental	Drug: lenalidomide

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779922

Contacts

Contact: Frank BRIDOUX, MD

05 49 44 42 39

f.bridoux@chu-poitiers.fr

Locations

France
Poitiers University Hospital
POITIERS, France, 86000

Sponsors and Collaborators

Poitiers University Hospital

More Information

Responsible Party:	( Frank BRIDOUX - MD - Prof - principal investigator )
Study ID Numbers:	REVIR
Study First Received:	October 23, 2008
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00779922
Health Authority:	France : Agence Française de sécurité sanitaire des produits de santé

Keywords provided by Poitiers University Hospital:

Multiple Myeloma
impaired renal function

Study placed in the following topic categories:

Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Lenalidomide
Paraproteinemias

Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009