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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