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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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).

Secondary outcome measures

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 outcome measures

Assess the DOR, PFS during 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

~1480

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Starton Therapeutics, IncLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research actively seeking participants?

"As per the data available on clinicaltrials.gov, this research is currently looking for participants to enroll in their trial. The study was initially posted on October 2nd 2023 and has been revised as of October 11th 2023."

Answered by AI

How extensive is the data-pool of participants in this clinical study?

"Affirmative, according to clinicaltrials.gov's data this ongoing medical experiment is enrolling patients. The study was published on October 2nd 2023 and its most recent update occurred on October 11th of the same year. A total of 6 participants are being recruited from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM)

2023. "Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06087653.

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