OncoMatch/Clinical Trials/NCT06087653
Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM)
Is NCT06087653 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including Lenalidomide and Lenalidomide 25 MG Oral Capsule for multiple myeloma.
Treatment: Lenalidomide · Lenalidomide 25 MG Oral Capsule — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Endocrine / hormonal
Other
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: first line therapy
Documented measurable disease following first line therapy
Must have received: lenalidomide, dexamethasone, and a proteasome inhibitor (lenalidomide, dexamethasone) — second line or greater
Intended to be treated in 2nd line or greater with lenalidomide, dexamethasone, and a PI
Cannot have received: autologous stem cell transplant
Autologous stem cell transplant (ASCT) ineligible; Received an ASCT
Cannot have received: lenalidomide (lenalidomide)
Exception: if failed to achieve an objective response (CR, VGPR or PR)
Received a prior treatment line containing lenalidomide and failed to achieve an objective response (CR, VGPR or PR)
Cannot have received: lenalidomide (lenalidomide)
Exception: if discontinued due to intolerability
Discontinued a prior line of treatment due to intolerability to lenalidomide
Cannot have received: investigational therapy
Exception: 28-day washout required
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.
Lab requirements
Blood counts
ANC ≥1,000 cells/mm3; Platelet count ≥75,000 cells/mm3; Hemoglobin ≥8.0 g/dL (RBC transfusions permitted if stable for 72 hours)
Kidney function
Calculated creatinine clearance ≥60 mL/min
Liver function
Total bilirubin ≤1.5 x ULN, or Gilbert's syndrome with total bilirubin <5.0 x ULN (with Medical Monitor approval); AST and ALT ≤3.0 x ULN
The following laboratory results must be met during screening: * ANC ≥1,000 cells/mm3 (1.0 x 10^9/L). * Platelet count ≥75,000 cells/mm3 (75 x 10^9/L). * Hemoglobin ≥8.0 g/dL (red blood cell (RBC) transfusions are permitted prior to initiation of study drug if hemoglobin is stable for 72 hours). * Total bilirubin ≤1.5 x upper limit of normal (ULN), or patient diagnosed with Gilberts syndrome with a total bilirubin <5.0 x ULN that has been reviewed and approved by the Medical Monitor. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x ULN. * Calculated creatinine clearance ≥60 mL/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Regional Oncology Center · Wilson, North Carolina
- Gabrail Cancer & Research Center · Canton, Ohio
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06087653 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior autologous stem cell transplant, lenalidomide, lenalidomide disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages