Could a Slow-Drip drug tame multiple myeloma with fewer side effects?

NCT ID NCT06087653

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This trial is testing whether giving lenalidomide as a continuous low-dose infusion under the skin, instead of as a pill, can treat multiple myeloma more safely and effectively. The study includes adults with multiple myeloma who are not eligible for a stem cell transplant. Participants receive the infusion alongside standard drugs (bortezomib and dexamethasone), and researchers will monitor side effects, drug levels in the blood, and how well the cancer responds.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Low-dose lenalidomide given as a continuous subcutaneous infusion, combined with bortezomib and dexamethasone
What this could lead to
If it works, this could offer a gentler, more effective way to control multiple myeloma, potentially improving quality of life and extending remission.
What could go wrong
This is an early-phase trial with only 24 participants, so results may not hold up in larger studies. The infusion could still cause side effects like fatigue, rash, or blood issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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 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). 10. 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. 11. Able to take anti-thrombotic prophylaxis. 12. 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. 13. 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). 14. Able and willing to receive percutaneous ambulatory therapy. 15. Has an in-home care partner willing to receive training from a nurse for assistance with pump management. Exclusion Criteria: 1. Pregnant or breastfeeding. 2. Received an ASCT. 3. Venous thromboembolism within 12 months of starting treatment on study. 4. Patients with active hepatitis B or C or human immunodeficiency virus (HIV) positive and on active therapy for those viral illnesses. 5. 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. 6. Received a prior treatment line containing lenalidomide and failed to achieve an objective response (CR, VGPR or PR). 7. Discontinued a prior line of treatment due to intolerability to lenalidomide. 8. 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). 9. Concurrent clinically significant amyloidosis or plasma cell leukemia or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes). 10. Known active infection requiring systemic anti-infective treatment (prophylactic treatment is permitted). 11. 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). 12. 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). 13. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Gabrail Cancer & Research Center

    RECRUITING

    Canton, Ohio, 44718, United States

  • Regional Oncology Center

    ACTIVE_NOT_RECRUITING

    Wilson, North Carolina, 27893, United States

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