PHARMACOKINETICS, SAFETY AND EFFICACY OF LENALIDOMIDE (REVLIMID®) IN COMBINATION WITH DEXAMETHASONE IN PATIENTS WITH MULTIPLE MYELOMA AND IMPAIRED RENAL FONCTIO

Conditions: multiple myeloma
MedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma

Registration Number: EUCTR2008-004580-19-FR

Lead Sponsor: CHU DE POITIERS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Documented diagnosis of relapsed or refractory multiple myeloma (MM).
- Age ³18 years at the time of signing the informed consent form
- ECOG performance status of £ 2 at study entry
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL not more than 3 days from the start of study drug and must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to monthly pregnancy testing and must be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure
-Stable renal function since the pre-screening visit: an up to 20% deviation from clearance creatinine according to Cockcroft and Gault formula will be acceptable·
- For subjects requiring dialysis, expected requirement of dialysis during all the duration of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Documented amyloidosis·
- Any prior use of Revlimid ®
- Any medical condition, laboratory abnormality, or psychiatric illness that would be sucpetible to interfere with the study procedures or its results, or to the investigator opinion, that would constitute a risk for the patient to participate to the study
- Any contraindication to Revlimid ® and especially:
Lack of acceptable method of birth control for female of childbearing potential (FCPB)Men don’t agree to use condom during the study and 4 weeks after the last study drug intake if her partner is a FCPB.
Pregnant or breast feeding women·
- Development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs·
- Hepatic Insufficiency ·
- Patients presenting with severe renal insufficiency requiring peritoneal dialysis
- Body Mass Index of greater than 38