STAR-LLD
A Protocol to Assess the Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Administration of Low-dose Lenalidomide (STAR-LLD) for the Treatment of Multiple Myeloma (MM)
What will happen during the trial?
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
More Information
- Trial Status
- Accepting patients
- Trial Phase
- Phase 1/2
- Enrollment
- 24 patients (estimated)
- Sponsors
- Starton Therapeutics, Inc
- Tags
- Immunomodulatory Drug (IMiD)
- Trial Type
- Treatment
- Last Update
- 1 month ago
- SparkCures ID
- 1782
- NCT Identifier
- NCT06087653
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