NCT06087653
Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM)
Recruiting · Phase 1, Phase 2 · Starton Therapeutics, Inc · registry updated 2026-08-24
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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....
Inclusion
- Male or female ≥18 years at the time of informed consent.
- Autologous stem cell transplant (ASCT) ineligible.
- SARS -CoV2 virus (COVID)-19 negative.
- A prior diagnosis of MM as defined by International Myeloma Working Group (IMWG) criteria (Appendix 7).
- Documented measurable disease following first line therapy defined as:
- Serum monoclonal protein ≥1.0 g/dL by protein electrophoresis.
Exclusion
- Pregnant or breastfeeding.
- Received an ASCT.
- Venous thromboembolism within 12 months of starting treatment on study.
- Patients with active hepatitis B or C or human immunodeficiency virus (HIV) positive and on active therapy for those viral illnesses.
- Currently taking any investigational therapy for the treatment of MM. A 28-day washout prior to Cycle 1 Day 1 is required for any previous investigational therapy.
- Received a prior treatment line containing lenalidomide and failed to achieve an objective response (CR, VGPR or PR).