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NCT06087653 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Multiple Myeloma, sponsored by Starton Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
24
Enrollment target
2
Study locations

NCT06087653: Recruiting Phase 1 study of Multiple Myeloma, sponsored by Starton Therapeutics.

NCT06087653 is a Phase 1 study of Multiple Myeloma that is actively recruiting participants, run by Starton Therapeutics. The registered enrollment target is 24 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06087653, a Phase 1 study of Multiple Myeloma, is actively recruiting participants, sponsored by Starton Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
24 participants
Enrollment target
2
Study locations

Study Summary

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 Studied

Multiple Myeloma

Interventions

  • DRUG Lenalidomide
  • DRUG Lenalidomide 25 MG Oral Capsule

Study Locations (2)

North Carolina

  • Regional Oncology Center - Wilson

Ohio

  • Gabrail Cancer & Research Center - Canton

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2023-10-02
Est. Completion 2027-03-31
Phase Phase 1

Sponsor

Starton Therapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06087653

The ClinicalTrials.gov registry entry for NCT06087653 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (96% lower). The listed sponsor is Starton Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Lenalidomide is the first listed.

NCT06087653 reports 2 study locations spanning 2 distinct geographic areas - top geographies include North Carolina, Ohio.

Frequently Asked Questions

What is clinical trial NCT06087653 about?

NCT06087653 is a clinical study titled "Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM)". 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 ...

What is the current status of trial NCT06087653?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-10-02. Estimated completion is 2027-03-31.

What conditions does trial NCT06087653 study?

This clinical trial studies the following conditions: Multiple Myeloma.

What interventions are being tested in trial NCT06087653?

The interventions under investigation include: Lenalidomide (DRUG), Lenalidomide 25 MG Oral Capsule (DRUG).

Who is sponsoring clinical trial NCT06087653?

This trial is sponsored by Starton Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06087653 being conducted?

This trial has 2 study locations across North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Read our methodology - how this data is sourced, computed, and verified.
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.