Multiple MyelomaPhase 1/2NCT06087653
Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM)
A Phase 1/2 study testing Lenalidomide and Lenalidomide 25 MG Oral Capsule in people with Multiple Myeloma, run by Starton Therapeutics, Inc at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Lenalidomide and Lenalidomide 25 MG Oral Capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Oct 2023to 31 Mar 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years at the time of informed consent.
- Autologous stem cell transplant (ASCT) ineligible.
- SARS -CoV2 virus (COVID)-19 negative.
- A prior diagnosis of MM as defined by International Myeloma Working Group (IMWG) criteria (Appendix 7).
- Documented measurable disease following first line therapy defined as:
- Serum monoclonal protein ≥1.0 g/dL by protein electrophoresis.
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- ≥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.
- Intended to be treated in 2nd line or greater with lenalidomide, dexamethasone, and a PI.
- Proteasome inhibitor sensitive defined as progression free for > 6 months from cessation of PI or never received a prior PI.
- Progression per IMWG criteria on the most recent line of therapy.
- Eastern Cooperative Oncology Group (ECOG-Appendix 1) performance status ≤2 (patients with a performance status of 3 based solely on bone pain secondary to MM may be eligible following consultation and approval by the Medical Monitor).
- Willing to comply with the protocol defined Lenalidomide Pregnancy Risk Minimization Plan for the prevention of pregnancy (Appendix 5). Females of childbearing potential (FCBP) must have a medically supervised negative serum or urine pregnancy test 4-14 days prior to planned start of treatment and again 24 hours prior to initiation of study medication. All FCBP must agree to either commit to continued abstinence from sexual intercourse or begin TWO acceptable methods of birth control AT THE SAME TIME, at least 28 days before receiving the first dose of STAR-LLD. FCBP must also agree to ongoing pregnancy testing. Males must agree to use a latex or synthetic condom during sexual contact with a FCBP from the time of starting study treatment through 28 days after the last dose, even if they have had a vasectomy.
- Able to take anti-thrombotic prophylaxis.
- The following laboratory results must be met during screening:
- ANC ≥1,000 cells/mm3 (1.0 x 109/L).
- Platelet count ≥75,000 cells/mm3 (75 x 109/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. Appendix 4
- Negative pregnancy test for FCBP (must be obtained within 4-14 days before the initiation of study drug.
- The following criteria must be met within 72 hours prior to first administration of continuous infusion STAR-LLD:
- ANC ≥1,000 cells/mm3 (1.0 x 109/L).
- Platelet count ≥75,000 cells/mm3 (75 x 109/L).
- Hemoglobin ≥8.0 g/dL (RBC transfusions are permitted prior to initiation of study drug if hemoglobin is stable for 72 hours).
- Calculated creatinine clearance ≥60 mL/min. Appendix 4
- Negative pregnancy test for FCBP (must be obtained within 24 hours of first dose of study drug).
- Able and willing to receive percutaneous ambulatory therapy.
- Has an in-home care partner willing to receive training from a nurse for assistance with pump management.
Who cannot join
- Pregnant or breastfeeding.
- Received an ASCT.
- Venous thromboembolism within 12 months of starting treatment on study.
- Patients with active hepatitis B or C or human immunodeficiency virus (HIV) positive and on active therapy for those viral illnesses.
- 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.
- Received a prior treatment line containing lenalidomide and failed to achieve an objective response (CR, VGPR or PR).
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- Discontinued a prior line of treatment due to intolerability to lenalidomide.
- Concomitant use of strong CYP3A inducers (see https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers#table3-3).
- Concurrent clinically significant amyloidosis or plasma cell leukemia or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes).
- Known active infection requiring systemic anti-infective treatment (prophylactic treatment is permitted).
- Prior malignancies within the previous 3 years, other than previously treated squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix or breast or another malignancy that is considered cured with minimal risk of recurrence (e.g., very low and low risk prostate cancer in active surveillance).
- Prior major surgical procedure or radiation therapy within 4 weeks of the initiation of STAR-LLD (this does not include limited course of radiation used for management of bone pain within 7 days of initiation of STAR-LLD).
- Any other condition that precludes adequate understanding, cooperation, and compliance with study procedures or any condition that could pose a risk to the patient's safety, as per the Investigator's judgment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
Gabrail Cancer & Research Center
Canton, Ohio, 44718
Carrie Smith, RN, 330-492-3345 ext. 208, csmith@gabrailcancercenter.com
Nashat Gabrail, MD
- Active, not recruiting
Regional Oncology Center
Wilson, North Carolina, 27893
About this study
Official title: A Protocol to Assess the Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Administration of Low-dose Lenalidomide (STAR-LLD) for the Treatment of 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
Read more
- • 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
- Multiple Myeloma
- Being tested
- Lenalidomide, Lenalidomide 25 MG Oral Capsule
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called bortezamib, dexamethasone
Low-dose lenalidomide continuous SC infusion (STAR-LDD) in combination with bortezomib and dexamethasone
Lenalidomide 25 MG Oral CapsuleDrug
Oral lenalidomide for active control
| Study group | Role | What they receive |
|---|---|---|
| ARM1 - Lenalidomide 400 mcg/h | Experimental | Lenalidomide 400 mcg/hr continuously for 28 of 28-day cycle Receives: Drug: Lenalidomide |
| Arm2 - Lenalidomide 300 mcg/h | Experimental | Lenalidomide 300 mcg/hr continuously for 28 of 28-day cycle Receives: Drug: Lenalidomide |
| Arm 3 - Lenalidomide 500 mcg/h | Experimental | Lenalidomide 500 mcg/hr continuously for 28 of 28-day cycle Receives: Drug: Lenalidomide |
| Arm 4 - Lenalidomide 600 mcg/h | Experimental | Lenalidomide 600 mcg/hr continuously for 28 of 28-day cycle Receives: Drug: Lenalidomide |
| Arm 5 - Lenalidomide oral capsule control | Active comparator | Lenalidomide 25mg/d oral capsules continuously for 28 of 28-day cycle Receives: Drug: Lenalidomide 25 MG Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Based on the incidence of adverse events associated with the use of the drug
Measured: 12 months
Secondary outcomes (4)
To assess the immunologic activity of natural killer (NK) cells and T cells for innate and humoral immunity.
Measure changes in T cell and NK cell function/exhaustion over the study by flow cytometry
Measured: 12 months
To establish the pharmacokinetic (PK) profile of STAR-LLD at a defined infusion rate targeting steady-state blood concentrations.
Meaured vs predicted blood concentrations of lenalidomide during the infusion and at steady state
Measured: 12 months
To determine pharmacodynamic (PD) changes with STAR-LLD in a panel of biomarkers associated with clinical response to lenalidomide.
Evaluate desirable changes in immune cells activity over therapy
Measured: 12 months
Evaluate changes in efficacy indicators including objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR).
An ORR of 60% is representative of patients being retreated with PI and Len
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start2 Oct 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dose defining study
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Starton Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087653
- Sponsor's protocol ID
- STAR LLD MM 023
- Status last verified
- Aug 2026
- First submitted
- 20 Sep 2023
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Protocol to Assess the Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Administration of Low-dose Lenalidomide (STAR-LLD) for the Treatment of Multiple Myeloma (MM)
- ClinicalTrials.gov ID
- NCT06087653
- Acronym / sponsor ID
- STAR LLD MM 023
- Conditions
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Starton Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Dose defining study
| Arm | Type | Receives |
|---|---|---|
| ARM1 - Lenalidomide 400 mcg/h | Experimental | Drug: LenalidomideLenalidomide 400 mcg/hr continuously for 28 of 28-day cycle |
| Arm2 - Lenalidomide 300 mcg/h | Experimental | Drug: LenalidomideLenalidomide 300 mcg/hr continuously for 28 of 28-day cycle |
| Arm 3 - Lenalidomide 500 mcg/h | Experimental | Drug: LenalidomideLenalidomide 500 mcg/hr continuously for 28 of 28-day cycle |
| Arm 4 - Lenalidomide 600 mcg/h | Experimental | Drug: LenalidomideLenalidomide 600 mcg/hr continuously for 28 of 28-day cycle |
| Arm 5 - Lenalidomide oral capsule control | Active comparator | Drug: Lenalidomide 25 MG Oral CapsuleLenalidomide 25mg/d oral capsules continuously for 28 of 28-day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Male or female ≥18 years at the time of informed consent.
- Autologous stem cell transplant (ASCT) ineligible.
- SARS -CoV2 virus (COVID)-19 negative.
- A prior diagnosis of MM as defined by International Myeloma Working Group (IMWG) criteria (Appendix 7).
- Documented measurable disease following first line therapy defined as:
Key exclusion criteria (13 listed)
- Pregnant or breastfeeding.
- Received an ASCT.
- Venous thromboembolism within 12 months of starting treatment on study.
- Patients with active hepatitis B or C or human immunodeficiency virus (HIV) positive and on active therapy for those viral illnesses.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenalidomideAlso: bortezamib, dexamethasoneLow-dose lenalidomide continuous SC infusion (STAR-LDD) in combination with bortezomib and dexamethasone | Drug | ARM1 - Lenalidomide 400 mcg/h, Arm 3 - Lenalidomide 500 mcg/h, Arm 4 - Lenalidomide 600 mcg/h, Arm2 - Lenalidomide 300 mcg/h |
| Lenalidomide 25 MG Oral CapsuleOral lenalidomide for active control | Drug | Arm 5 - Lenalidomide oral capsule control |
Primary outcome
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
4 secondary outcomes
To assess the immunologic activity of natural killer (NK) cells and T cells for innate and humoral immunity.
Time frame: 12 months
To establish the pharmacokinetic (PK) profile of STAR-LLD at a defined infusion rate targeting steady-state blood concentrations.
Time frame: 12 months
To determine pharmacodynamic (PD) changes with STAR-LLD in a panel of biomarkers associated with clinical response to lenalidomide.
Time frame: 12 months
Evaluate changes in efficacy indicators including objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR).
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lenalidomide and Lenalidomide 25 MG Oral Capsule in people with Multiple Myeloma, run by Starton Therapeutics, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Chergey (949 433 6750, achergey@startontx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.