Actively Recruiting
Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM)
Led by Starton Therapeutics, Inc · Updated on 2025-06-19
24
Participants Needed
2
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years or older at the time of informed consent
- Ineligible for autologous stem cell transplant (ASCT)
- Negative for SARS-CoV-2 (COVID-19) infection
- Diagnosed with multiple myeloma according to International Myeloma Working Group criteria
- Documented measurable disease after first-line therapy with specified protein or free light chain levels
- Intended treatment in second line or later with lenalidomide, dexamethasone, and a proteasome inhibitor
- Proteasome inhibitor sensitive, defined as progression-free for more than 6 months after stopping prior PI or no prior PI use
- Disease progression according to IMWG criteria on most recent therapy
- ECOG performance status of 0, 1, or 2 (patients with status 3 due to bone pain may be eligible with approval)
- Willing to follow the Lenalidomide Pregnancy Risk Minimization Plan including pregnancy testing and birth control requirements
- Able to take anti-thrombotic prophylaxis
- Laboratory values within specified limits for blood counts, liver function, and kidney function
- Able and willing to receive percutaneous ambulatory therapy
- Has an in-home care partner willing to assist with pump management after nurse training
You will not qualify if you...
- Pregnant or breastfeeding
- Prior autologous stem cell transplant
- Venous thromboembolism within 12 months before study start
- Active hepatitis B or C infection, or HIV positive on active therapy
- Currently receiving investigational therapy for multiple myeloma or less than 28-day washout from prior investigational treatment
- Previous lenalidomide treatment without achieving objective response
- Discontinued prior treatment due to intolerance to lenalidomide
- Concurrent use of strong CYP3A inducers
- Presence of clinically significant amyloidosis, plasma cell leukemia, or POEMS syndrome
- Active infection requiring systemic treatment (prophylactic treatments allowed)
- Prior malignancies within 3 years except certain treated skin or cervical cancers or low-risk prostate cancer under surveillance
- Major surgery or radiation therapy within 4 weeks before starting study drug (except limited radiation for bone pain within 7 days)
- Any other condition that impairs understanding, cooperation, or safety as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Regional Oncology Center
Wilson, North Carolina, United States, 27893
Active, Not Recruiting
2
Gabrail Cancer & Research Center
Canton, Ohio, United States, 44718
Actively Recruiting
Research Team
A
Amy Chergey
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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