Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM)

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 sy

Trial Details

NCT ID
NCT06087653
Phase
PHASE1 / PHASE2
Sponsor
Starton Therapeutics, Inc
Status
RECRUITING
Cancer Type
Multiple Myeloma
Interventions
  • Lenalidomide
  • Lenalidomide 25 MG Oral Capsule
Locations (sample)
  • Wilson, North Carolina, United States|35.72127,-77.91554
  • Canton, Ohio, United States|40.79895,-81.37845

Key Eligibility Criteria

  • 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).

For full eligibility, visit ClinicalTrials.gov.

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