MedTrace Logo

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

NCT06087653 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-06-19

No results posted yet for this study

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 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.
* Rate of complete response, very good partial response (VGPR), partial response (PR), stable disease (SD), and progressive disease.
* Determination of ORR, PFS, and DOR

Conditions

Interventions

DRUG

Lenalidomide

Low-dose lenalidomide continuous SC infusion (STAR-LDD) in combination with bortezomib and dexamethasone

DRUG

Lenalidomide 25 MG Oral Capsule

Oral lenalidomide for active control

Sponsors & Collaborators

  • Starton Therapeutics, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-02
Primary Completion
2026-05-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06087653 on ClinicalTrials.gov