An Open-label, Pharmacokinetic Study of Lenalidomide (Revlimid) and High-dose Dexamethasone Induction Therapy in Previously Untreated Multiple Myeloma Patients With Various Degrees of Renal Dysfunction - Validation of Official Dosing Guidelines for Renal Failure
STUDY DESIGN:
This is a single institution open label, pharmacokinetic validation study of the combination
of lenalidomide with dexamethasone for firstline induction therapy in transplant-eligible MM
( Multiple Myeloma ) patients with various degrees of renal failure. There will be 4
patient groups with various degrees of renal function (based on creatinine clearance
calculated from a 24 hour urine collection and requirement for dialysis). Each group will
receive lenalidomide dosing as per official recommended guidelines:
Group 1 Normal {CrCl(creatinine clearance)>60 mL/min}25 mg (full-dose)-Daily for 21 days of
a 28 Day cycle1 Group 2 Moderate renal impairment {30 ≤ CrCl (creatinine clearance) <60
mL/min}10 mg Daily for 21 days of a 28 day cycle Group 3 Severe renal impairment {CrCl
(creatinine clearance)<30 mL/min, not requiring dialysis}15 mg Every 48 hours for 21 days of
a 28 day cycle (11 PLANNED DOSES EACH 28 DAY CYCLE) Group 4 End-stage renal failure {CrCl
(creatinine clearance)<30 mL/min, requiring dialysis}5 mg Once daily for 21 days of a 28 day
cycle On dialysis days the dose should be administered following dialysis.
Pharmacokinetic (PK) studies: We will be evaluating PK studies following single and multiple
doses of lenalidomide during Cycle 1.Patients will receive their first dose of lenalidomide
(Cycle 1, day 1) as per the above designated patient group. PK (pharmacokinetic)sampling
for 1st dose only will be drawn at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose for
group 1 and at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours for all other groups. The
2nd dose of lenalidomide will be administered on Day 4 for all patients (i.e. no doses on
Days 2 and 3). On Day 17 (after 14 doses of lenalidomide administered), repeat PK sampling
will be performed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours for groups 1, 2 and 4 (before
next hemodialysis for those in group 4). Repeat PK sampling for group 3 will be performed
at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Serum Pharmacokinetic (PK) analysis of Study drug Lenalidomide
PK data will be analyzed and reported after completion of PK studies in all patients
16 months
Yes
Canada: Health Canada
RV-MM-PI-0505
NCT01270932
November 2010
April 2012
Name | Location |
---|