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

This study has been completed.
Sponsor:
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT00779922
First received: October 23, 2008
Last updated: October 10, 2016
Last verified: October 2016
  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:

Enrollment: 39
Study Start Date: November 2008
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group 1 to 5 Drug: lenalidomide

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Locations
France
Poitiers University Hospital
Poitiers, France, 86000
Sponsors and Collaborators
Poitiers University Hospital
  More Information

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: October 10, 2016
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
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on December 02, 2016