Lenalidomide & High Dose Dexamethasone for Untreated Multiple Myeloma Renal Failure Patients

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

Timeline

Start

2010-11

Primary completion

2017-12-18

Completion

2017-12-18

Publications

• Chen CI, Cao Y, Trudel S, Reece DE, Kukreti V, Tiedemann R, Prica A, Paul H, Le LW, Levina O, Kakar S, Lau A, Chen H, Chen E. An open-label, pharmacokinetic study of lenalidomide and dexamethasone therapy in previously untreated multiple myeloma (MM) patients with various degrees of renal impairment - validation of official dosing guidelines. Leuk Lymphoma. 2020 Aug;61(8):1860-1868. doi: 10.1080/10428194.2020.1747064. Epub 2020 May 31.

Drugs

Indications