STAR-LLD

Primary Objective

• Assess the safety and tolerability of low-dose lenalidomide administered by continuous subcutaneous (SC) infusion (STAR-LLD) in combination with dexamethasone and a proteasome inhibitor (PI).

Secondary Objectives

• To assess the immunologic activity of natural killer (NK) cells and T cells for innate and humoral immunity.
• To establish the pharmacokinetic (PK) profile of STAR-LLD at a defined infusion rate targeting steady-state blood concentrations.
• To determine pharmacodynamic (PD) changes with STAR-LLD in a panel of biomarkers associated with clinical response to lenalidomide.
• Evaluate changes in efficacy indicators including objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR).

Exploratory Objective

• To assess the impact of STAR-LLD on patient reported symptoms and outcomes. Primary Endpoints
• The grade, frequency, and relationship of treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESIs): (gastrointestinal [GI] toxicity, fatigue, hematologic toxicity, rash (non-infusion site).
• The observation of dose-limiting toxicities (DLTs) of STAR-LLD during Cycle 1. Secondary Endpoints
• Immune profiles, functional assays for NK cell activation and antigen specific T-cell activity.
• Blood concentrations of lenalidomide at on Day 1 and at steady state.
• Changes in biomarkers during treatment.
• Rate of complete response, very good partial response (VGPR), partial response (PR), stable disease (SD), and progressive disease.
• Determination of ORR, PFS, and DOR