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

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lenalidomide — DRUG
  Low-dose lenalidomide continuous SC infusion (STAR-LDD) in combination with bortezomib and dexamethasone
• Lenalidomide 25 MG Oral Capsule — DRUG
  Oral lenalidomide for active control

Study Details

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

Key Dates

Start date

Oct 2, 2023

Status verified

Jun 2025

Primary completion

May 31, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

24 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ARM1 - Lenalidomide 400 mcg/h
  Lenalidomide 400 mcg/hr continuously for 28 of 28-day cycle
• Experimental: Arm2 - Lenalidomide 300 mcg/h
  Lenalidomide 300 mcg/hr continuously for 28 of 28-day cycle
• Experimental: Arm 3 - Lenalidomide 500 mcg/h
  Lenalidomide 500 mcg/hr continuously for 28 of 28-day cycle
• Experimental: Arm 4 - Lenalidomide 600 mcg/h
  Lenalidomide 600 mcg/hr continuously for 28 of 28-day cycle
• Active Comparator: Arm 5 - Lenalidomide oral capsule control
  Lenalidomide 25mg/d oral capsules continuously for 28 of 28-day cycle

Primary Outcome Measure

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). [ Time Frame: 12 months ]

Central Contacts

• Amy Chergey
  949 433 6750
  [email protected]

Locations (2)

Find similar trials in Wilson, NC

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