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Immunomodulatory Agent

Subcutaneous Lenalidomide for Multiple Myeloma

Phase 1 & 2

Recruiting

Research Sponsored by Starton Therapeutics, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Intended to be treated in 2nd line or greater with lenalidomide, dexamethasone, and a PI

Eastern Cooperative Oncology Group (ECOG) performance status ≤2

Must not have

Patients with active hepatitis B or C or human immunodeficiency virus (HIV) positive and on active therapy for those viral illnesses

Concomitant use of strong CYP3A inducers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial evaluates the safety and tolerability of a drug for cancer, plus its effectiveness and side effects.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include gastrointestinal issues like nausea or diarrhea, fatigue, low blood cell counts which can increase infection risk or cause anemia (low red cells) or bleeding problems (low platelets), rashes not related to injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I can take care of myself but might not be able to do heavy physical work.

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I can take medication to prevent blood clots.

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My kidneys are functioning well.

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I am willing and able to receive treatment through a needle in my skin.

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My hemoglobin level is at least 8.0 g/dL, and I may have had a blood transfusion to reach this.

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I am not eligible for a stem cell transplant using my own cells.

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I have been diagnosed with multiple myeloma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am not taking medication that strongly affects liver enzyme activity.

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I do not have amyloidosis, plasma cell leukemia, or POEMS syndrome.

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I am currently on medication for an active infection.

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I was treated with lenalidomide but did not respond well.

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I stopped a previous treatment because I couldn't tolerate lenalidomide.

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I have undergone a stem cell transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Evaluate changes in efficacy indicators including objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR).

To assess the immunologic activity of natural killer (NK) cells and T cells for innate and humoral immunity.

To determine pharmacodynamic (PD) changes with STAR-LLD in a panel of biomarkers associated with clinical response to lenalidomide.

+1 more

Other study objectives

Assess the DOR, PFS during treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Study ARM1 - Vld (Velcade-lenalidomide-dexamethasone)Experimental Treatment1 Intervention

Bortezomib SC at 1.3 mg/m2 on Days 1, 8, 15, and 22 of each 28-day cycle Lenalidomide 400 mcg/hr continuously for 28 of 28-day cycle Dexamethasone 40mg orally on Days 1, 8, 15 and 22 of each 28-day cycle (age 75 or over 20 mg.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~2240

0 / 15Eligibility criteria met