Mm-014: A Phase 2 Trial Evaluating Efficacy, Safety, And Biomarkers Of Pomalidomide Plus Low-Dose Dexamethasone (Pom Plus Lodex) Is Relapsed/Refractory Multiple Myeloma (Rrmm) Following Second-Line Lenalidomide Plus Dexamethasone (Len Plus Dex)

TPS8627 Background: Challenging relapsed disease with drugs of the same class remains an area of investigation. Subanalyses of MM-002 and MM-003 in advanced RRMM demonstrated comparable efficacy for POM + LoDEX in patients (pts) refractory to LEN as last prior treatment (Tx) vs. all pts (Richardson, 2014; San Miguel, 2013). To confirm this, MM-014, a multicenter, single-arm, open-label phase 2 trial in the US and Canada evaluating POM + LoDEX immediately following second-line LEN + DEX, was designed (NCT01946477). Methods: Pts (N = 85 planned) must have received 2 prior lines of myeloma Tx, with LEN + DEX as second line. Pts must have relapsed from or become refractory to LEN + DEX as last prior Tx (≥ 2 cycles). Prior Tx may include all predetermined components of induction followed by ASCT and maintenance. Key exclusion criteria are creatinine clearance 2, neutrophils u003c 1000/μL, platelets u003c 75,000 or u003c 30,000/μL (for pts with u003c 50% or ≥ 50% of bone marrow [BM] nu...