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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00779922
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : October 11, 2016
Sponsor:
Information provided by:
Poitiers University Hospital

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Impaired Renal Function Drug: lenalidomide Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Study Start Date : November 2008
Actual Primary Completion Date : September 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: group 1 to 5 Drug: lenalidomide


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00779922


Locations
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France
Poitiers University Hospital
Poitiers, France, 86000
Sponsors and Collaborators
Poitiers University Hospital
More Information
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Responsible Party: Frank BRIDOUX - MD - Prof - principal investigator
ClinicalTrials.gov Identifier: NCT00779922    
Other Study ID Numbers: REVIR
First Posted: October 24, 2008    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016
Keywords provided by Poitiers University Hospital:
Multiple Myeloma
impaired renal function
Additional relevant MeSH terms:
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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