OncoMatch/Clinical Trials/NCT06087653
Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM)
Is NCT06087653 recruiting? Yes, currently enrolling (May 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
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
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