Subcutaneous Lenalidomide for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Starton Therapeutics, Inc

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?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 assess the immunologic activity of natural killer (NK) cells and T cells for innate and humoral immunity. * To establish the pharmacokinetic (PK) profile of STAR-LLD at a defined infusion rate targeting steady-state blood concentrations. * To determine pharmacodynamic (PD) changes with STAR-LLD in a panel of biomarkers associated with clinical response to lenalidomide. * 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 * Immune profiles, functional assays for NK cell activation and antigen specific T-cell activity. * 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

Eligibility Criteria

Adults with Multiple Myeloma who haven't responded well to their first treatment can join this trial. They must have certain levels of monoclonal protein in urine or blood, normal organ function, and no recent major surgeries. Pregnant women, those with a history of blood clots or other cancers within the last 3 years, and patients with HIV or hepatitis are excluded.

Inclusion Criteria

I am 18 years old or older.

I am planned to be treated with lenalidomide, dexamethasone, and a protease inhibitor as my second or later line of therapy.

My condition did not worsen for over 6 months after stopping a proteasome inhibitor, or I have never received one.

+24 more

Exclusion Criteria

I have had no cancers in the last 3 years, except for certain skin cancers or early-stage cervical or breast cancer.

I haven't had major surgery or radiation within the last 4 weeks.

I have active hepatitis B or C or HIV and am receiving treatment for it.

+10 more

Participant Groups

The trial is testing a new way to give lenalidomide through continuous skin injections combined with dexamethasone and a proteasome inhibitor. It aims to see if this method is safe, how it affects the immune system and cancer markers, and whether it improves patient outcomes like response rate and survival without disease progression.

1Treatment groups

Experimental Treatment

Group I: Study ARM1 - Vld (Velcade-lenalidomide-dexamethasone)Experimental Treatment1 Intervention

Bortezomib SC at 1.3 mg/m2 on Days 1, 8, 15, and 22 of each 28-day cycle Lenalidomide 400 mcg/hr continuously for 28 of 28-day cycle Dexamethasone 40mg orally on Days 1, 8, 15 and 22 of each 28-day cycle (age 75 or over 20 mg.

Lenalidomide is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Revlimid for: