multiple myeloma MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Trade Name: REVLIMID
Pharmaceutical Form: Capsule*
INN or Proposed INN: LENALIDOMIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: LENALID
Sponsors
CHU DE POITIERS
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the pharmacokinetic profile of Revlimid® in patients presenting with Multiple Myeloma and impaired renal function.;Secondary Objective: To describe the safety of Revlimid® in the enrolled patients population.· To evaluate the efficacy of Revlimid®-Dexamethasone combination in patients presenting MM and impaired renal function at completion of 3 cycles of treatment.;Primary end point(s): PK parameters: Maximum plasma concentration (Cmax), Time to Cmax (Tmax), Area Under the plasma concentration-time–Curve (AUC), Terminal Half Life (t1/2), apparent clearance (CL/F), apparent volume of distribution, (Vz | — |
Countries
France
Outcome results
None listed