Subcutaneous Lenalidomide for Multiple Myeloma

Recruiting at 1 trial location

Overseen By Amy Chergey

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Starton Therapeutics, Inc

Must be taking: Lenalidomide, Dexamethasone, Proteasome inhibitors

Must not be taking: Strong CYP3A inducers

Disqualifiers: Pregnancy, Hepatitis B/C, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 28-day cycles

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of administering lenalidomide, a medication for multiple myeloma, to assess its safety and effectiveness when delivered subcutaneously with a continuous pump. Researchers aim to understand how the body absorbs this treatment and whether it prolongs cancer remission. Participants will receive either varying doses of the new pump treatment or take lenalidomide as a pill. This trial is suitable for individuals with multiple myeloma who have not undergone a stem cell transplant and are ready to begin a second or subsequent round of treatment. As a Phase 1 trial, the research focuses on understanding how the treatment functions in people.

Do I have to stop taking my current medications for the trial?

The trial requires a 28-day period without any investigational therapy before starting. You cannot use strong CYP3A inducers during the trial. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lenalidomide, especially in pill form, is widely used and approved by the FDA for treating conditions like multiple myeloma, indicating it is generally safe when taken orally. However, this trial tests a new method of administration: injecting it under the skin.

Other studies have linked the use of lenalidomide with dexamethasone (a type of steroid) to higher risks of heart attacks and strokes, particularly in people with multiple myeloma. A small number of patients experienced serious side effects when taking lenalidomide with other drugs.

The method of injecting the drug under the skin remains under investigation, so researchers are closely monitoring its safety. They are checking for any new problems that might occur during treatment, such as stomach issues, tiredness, blood problems, or skin rashes. This trial carefully evaluates how participants handle this new method.

While lenalidomide is usually safe in pill form, participants should be aware that the safety of the injection method is still under study. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the subcutaneous delivery of Lenalidomide for multiple myeloma because it promises a new method of administration that differs from the traditional oral capsule form. Unlike the standard of care that relies on oral intake, using subcutaneous methods could potentially improve patient convenience and reduce gastrointestinal side effects. This trial explores a range of dosing levels (300, 400, 500, and 600 mcg/h) that might offer more personalized treatment options, tailoring the therapy to individual patient needs. This innovative approach could enhance treatment adherence and effectiveness by simplifying the regimen and minimizing the burden of daily pill intake.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Research has shown that injecting lenalidomide under the skin can effectively treat multiple myeloma. Studies have found that administering lenalidomide in small, continuous doses this way causes fewer side effects than oral dosing. Notably, no serious blood-related side effects occurred, which are often a concern with oral administration. Additionally, using this method for six or more treatment cycles proved effective for patients whose multiple myeloma returned or did not respond to other treatments, leading to longer periods without disease progression. These findings suggest that subcutaneous lenalidomide could be a promising treatment option for multiple myeloma. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Adults with Multiple Myeloma who haven't responded well to their first treatment can join this trial. They must have certain levels of monoclonal protein in urine or blood, normal organ function, and no recent major surgeries. Pregnant women, those with a history of blood clots or other cancers within the last 3 years, and patients with HIV or hepatitis are excluded.

Inclusion Criteria

I am planned to be treated with lenalidomide, dexamethasone, and a protease inhibitor as my second or later line of therapy.

My condition did not worsen for over 6 months after stopping a proteasome inhibitor, or I have never received one.

You have more than 200 milligrams of a specific type of protein in your urine over a 24-hour period.

Exclusion Criteria

I have had no cancers in the last 3 years, except for certain skin cancers or early-stage cervical or breast cancer.

I haven't had major surgery or radiation within the last 4 weeks.

I have active hepatitis B or C or HIV and am receiving treatment for it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Continuous subcutaneous administration of low-dose lenalidomide in combination with dexamethasone and a proteasome inhibitor

28-day cycles

Continuous monitoring with regular assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Extension

Long-term follow-up to assess progression-free survival and duration of response

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Lenalidomide

Trial Overview The trial is testing a new way to give lenalidomide through continuous skin injections combined with dexamethasone and a proteasome inhibitor. It aims to see if this method is safe, how it affects the immune system and cancer markers, and whether it improves patient outcomes like response rate and survival without disease progression.

How Is the Trial Designed?

Group I: Arm2 - Lenalidomide 300 mcg/h Experimental Treatment 1 Intervention

Lenalidomide 300 mcg/hr continuously for 28 of 28-day cycle

Group II: Arm 4 - Lenalidomide 600 mcg/h Experimental Treatment 1 Intervention

Lenalidomide 600 mcg/hr continuously for 28 of 28-day cycle

Group III: Arm 3 - Lenalidomide 500 mcg/h Experimental Treatment 1 Intervention

Lenalidomide 500 mcg/hr continuously for 28 of 28-day cycle

Group IV: ARM1 - Lenalidomide 400 mcg/h Experimental Treatment 1 Intervention

Lenalidomide 400 mcg/hr continuously for 28 of 28-day cycle

Group V: Arm 5 - Lenalidomide oral capsule control Active Control 1 Intervention

Lenalidomide 25mg/d oral capsules continuously for 28 of 28-day cycle

Lenalidomide is already approved in European Union, United States for the following indications:

Approved in European Union as Revlimid for:

• Multiple myeloma
• Myelodysplastic syndromes
• Mantle cell lymphoma
• Follicular lymphoma
• Marginal zone lymphoma

Approved in United States as Revlimid for:

• Multiple myeloma
• Myelodysplastic syndromes
• Mantle cell lymphoma
• Follicular lymphoma
• Marginal zone lymphoma

Who Is Running the Clinical Trial?

Starton Therapeutics, Inc

Lead Sponsor

Trials

1

Recruited

6+

Citations

1. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_2/LB207/761896/Abstract-LB207-Continuous-subcutaneous

Abstract LB207: Continuous subcutaneous lenalidomide ... Continuous delivery of low dose Len provides meaningful efficacy and improved tolerability with no grade >3 drug-related hematologic toxicity.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06087653

Study Details | NCT06087653 | Safety, Efficacy, and ... Study Details | NCT06087653 | Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM) | ClinicalTrials.gov.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10729307/

Lenalidomide use in multiple myeloma (Review) - PMC Additionally, a phase 2 study (JCOG0904) (48) revealed that patients with RRMM undergoing VRD treatment exhibited satisfactory 1-year PFS (45.5%) and 3-year OS ...

4. pharmacytimes.com pharmacytimes.com/view/continuous-subcutaneous-lenalidomide-shows-promise-in-reducing-toxicity-in-r-r-multiple-myeloma

Continuous Subcutaneous Lenalidomide Shows Promise ... Data from a phase 1b study showed significantly reduced toxicity compared with conventional oral dosing.

5. bloodcancerstoday.com bloodcancerstoday.com/post/clinical-study-finds-continuous-lenalidomide-delivery-effective-and-well-tolerated-in-rrmm

Clinical Study Finds Continuous Lenalidomide Delivery ... Administration of lenalidomide continuously for six or more cycles shows meaningful efficacy in patients with relapsed or refractory multiple myeloma (RRMM) ...

6. bmsaccesssupport.com bmsaccesssupport.com/revlimid/indications-important-safety-information.html

REVLIMID® (lenalidomide) | Indications and Important ... Fatal adverse reactions occurred in 6 patients (1.5%) receiving REVLIMID + rituximab across both trials. Fatal adverse reactions (1 each) included: cardio- ...

7. myeloma.org myeloma.org/revlimid-lenalidomide

Revlimid (Lenalidomide) The risk is even higher for people with multiple myeloma who take dexamethasone with Revlimid. Heart attacks and strokes are also more frequent in people who ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5013840/

Revlimid (Lenalidomide) Now FDA Approved as First-Line ... The new FDA indication provides a convenient oral treatment option for patients with multiple myeloma based on data demonstrating superior efficacy.

9. ema.europa.eu ema.europa.eu/en/documents/product-information/revlimid-epar-product-information_en.pdf

Revlimid, INN-lenalidomide - EMA Revlimid should not be used in children and adolescents from birth to less than 18 years because of safety concerns (see section 5.1). •. Elderly. Currently ...