MM-013: An ongoing phase 2 trial of pomalidomide and low-dose dexamethasone (POM + LoDEX) in relapsed/refractory multiple myeloma (RRMM) with moderate or severe renal impairment (RI) including patients (pts) undergoing hemodialysis.

TPS8626 Background: RI occurs in > 40% of MM pts and can be associated with poor prognosis (Knudsen, EJH 2000). Data from 2 pivotal trials (MM-002, MM-003) suggested comparable efficacy and tolerability for POM + LoDEX in pts with or without moderate RI (Siegel, ASH 2012; Weisel, ASCO 2013). However, pts with severe RI were excluded from these trials. Because POM is extensively metabolized, with < 5% of active substance eliminated in the urine, RI may not affect POM exposure in a clinically relevant manner. However, this has not been definitively tested in a clinical trial, and is under investigation in the US in MM-008. MM-013is a European, multicenter, open-label phase 2 study designed to assess the efficacy, safety, and pharmacokinetics (PK) of POM + LoDEX in RRMM pts with moderate or severe RI, including those undergoing dialysis (NCT02045017). Methods: The trial is enrolling RRMM pts (N = 80) across 3 cohorts: Cohort A (n = 33 with moderate RI, estimated glomerular filtration rate [eGFR] ≥ 30 and < 4...