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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Poitiers University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT00779922
First received: October 23, 2008
Last updated: January 29, 2010
Last verified: January 2010
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study

Resource links provided by NLM:


Further study details as provided by Poitiers University Hospital:

Estimated Enrollment: 46
Study Start Date: November 2008
Arms Assigned Interventions
Experimental: group 1 to 5 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Recruiting
Poitiers, France, 86000
Contact: Frank BRIDOUX    05 49 44 42 39      
Sponsors and Collaborators
Poitiers University Hospital
  More Information

No publications provided

Responsible Party: Frank BRIDOUX - MD - Prof - principal investigator
ClinicalTrials.gov Identifier: NCT00779922     History of Changes
Other Study ID Numbers: REVIR
Study First Received: October 23, 2008
Last Updated: January 29, 2010
Health Authority: France : Agence Française de sécurité sanitaire des produits de santé

Keywords provided by Poitiers University Hospital:
Multiple Myeloma
impaired renal function

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Renal Insufficiency
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Kidney Diseases
Urologic Diseases
Lenalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014