Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT01270932
Brief Summary:
Primary:
• To validate the initial dosing recommendations for newly diagnosed MM (Mutiple Myeloma) patients with various degrees of renal failure using pharmacokinetic studies
Secondary:
* To evaluate the safety of lenalidomide and dexamethasone as induction therapy in newly-diagnosed MM (Multiple Myeloma) patients with renal dysfunction using modified dosing guidelines
* To evaluate clinical response of lenalidomide and dexamethasone after 4 cycles using the modified dosing guidelines
* To evaluate the ability to collect stem cells after 4 cycles of lenalidomide and dexamethasone induction therapy in MM (Multiple Myeloma) patients with renal failure
Detailed Description:
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.
Study:
NCT01270932
Study Brief:
Protocol Section:
NCT01270932