Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM)
Status:
Recruiting
Trial end date:
2024-09-01
Target enrollment:
Participant gender:
Summary
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