Back to resultsPharmacokinetics of Lenalidomide (Revlimid®) in Patients With Multiple Myeloma and Impaired Renal Function
Primary Purpose
Multiple Myeloma, Impaired Renal Function
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
lenalidomide
Sponsored by
About this trial
This is an interventional trial for Multiple Myeloma focused on measuring Multiple Myeloma, impaired renal function
Eligibility 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
Sites / Locations
- Poitiers University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
group 1 to 5
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00779922
First Posted
October 23, 2008
Last Updated
October 10, 2016
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00779922
Brief Title
Pharmacokinetics of Lenalidomide (Revlimid®) in Patients With Multiple Myeloma and Impaired Renal Function
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Impaired Renal Function
Keywords
Multiple Myeloma, impaired renal function
7. Study Design
Study Phase
Phase 2
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1 to 5
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
lenalidomide
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Poitiers University Hospital
City
Poitiers
ZIP/Postal Code
86000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics of Lenalidomide (Revlimid®) in Patients With Multiple Myeloma and Impaired Renal Function
We'll reach out to this number within 24 hrs