NCT06087653 · Starton Therapeutics, Inc
Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM)
What this study is about
Primary Objective • Assess the safety and how well patients handle the treatment of low-dose lenalidomide administered by continuous injected under the skin (SC) infusion (STAR-LLD) in combination with dexamethasone and a proteasome inhibitor (PI).
View original scientific description
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.
Interventions
DRUG
Lenalidomide
Low-dose lenalidomide continuous SC infusion (STAR-LDD) in combination with bortezomib and dexamethasone
DRUG
Lenalidomide 25 MG Oral Capsule
Oral lenalidomide for active control
Primary outcome measures
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).
Time frame: 12 months
Based on the incidence of adverse events associated with the use of the drug
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female ≥18 years at the time of informed consent. 2. Autologous stem cell transplant (ASCT) ineligible. 3. SARS -CoV2 virus (COVID)-19 negative. 4. A prior diagnosis of MM as defined by International Myeloma Working Group (IMWG) criteria (Appendix 7). 5. Documented measurable disease following first line therapy defined as:
- Serum monoclonal protein ≥1.0 g/dL by protein electrophoresis.
- ≥200 mg/24 hours of monoclonal protein in the urine on 24-hour electrophoresis.
- Serum free light chain (SFLC) ≥10 mg/dL AND abnormal serum kappa to lambda free light chain (FLC) ratio. 6. Intended to be treated in 2nd line or greater with lenalidomide, dexamethasone, and a PI. 7. Proteasome inhibitor sensitive defined as progression free for \> 6 months from cessation of PI or never received a prior PI. 8. Progression per IMWG criteria on the most recent line of therapy. 9. Eastern Cooperative Oncology Group (ECOG-Appendix 1) performance status ≤2 (patients
Where
- Wilson, North Carolina
- Canton, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 19, 2025 · Source of record for eligibility and locations