MM-014: A phase 2 trial evaluating efficacy, safety, and biomarkers of pomalidomide plus low-dose dexamethasone (POM + LoDEX) in relapsed/refractory multiple myeloma (RRMM) following second-line lenalidomide plus dexamethasone (LEN + 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 < 1000/μL, platelets < 75,000 or < 30,000/μL (for pts with < 50% or ≥ 50% of bone marrow [BM] nu...