from the ClinicalTrials.gov record
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 establish the pharmacokinetic (PK) profile of STAR-LLD at a defined infusion rate targeting steady-state blood concentrations.
* • 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
•• 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