- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00779922
Pharmacokinetics of Lenalidomide (Revlimid®) in Patients With Multiple Myeloma and Impaired Renal Function
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Poitiers, France, 86000
- Poitiers university hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: group 1 to 5
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Kidney Diseases
- Urologic Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Renal Insufficiency
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Lenalidomide
Other Study ID Numbers
- REVIR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Myeloma
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Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
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National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
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Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on lenalidomide
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Sidney Kimmel Comprehensive Cancer Center at Johns...TerminatedMyelodysplastic SyndromeUnited States
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Grupo Español de Linfomas y Transplante Autólogo...Celgene Corporation; Dynamic Science S.L.; Thermo Fisher Scientific, IncCompleted
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Celgene CorporationICON Clinical ResearchCompletedMyelodysplastic SyndromesGermany, Israel, United Kingdom, Spain, Belgium, Italy, France, Netherlands, Sweden
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Boston VA Research Institute, Inc.Celgene Corporation; Edward Hines Jr. VA Hospital; Michael E. DeBakey VA Medical... and other collaboratorsCompletedMultiple MyelomaUnited States
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Swiss Group for Clinical Cancer ResearchTerminatedLymphomaSwitzerland, Norway, Sweden
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Dana-Farber Cancer InstituteBeth Israel Deaconess Medical Center; Genentech, Inc.; Brigham and Women's Hospital and other collaboratorsTerminatedWaldenstrom's MacroglobulinemiaUnited States
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University Hospital, ToulouseCelgene Corporation; Janssen-Cilag Ltd.Completed
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CelgeneCompletedRelapsed or Refractory Chronic Lymphocytic LeukemiaUnited States, Canada, United Kingdom, France, Germany, Spain, Italy, Sweden
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Groupe Francophone des MyelodysplasiesUnknownMyelodysplastic SyndromesFrance