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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.
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
Primary Outcome
Based on the incidence of adverse events associated with the use of the drug
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-10-02 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 1 |
What NCT06087653 shows while recruiting
NCT06087653 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06087653's enrollment target sits among peer trials
24 377th of 438 higher than 61 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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