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Luspatercept + Lenalidomide for Myelodysplastic Syndrome

Phase 1 & 2

Recruiting

Research Sponsored by Mikkael Sekeres MD

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2 (Appendix 1)

- average transfusion requirement of ≥ 2 units/8 weeks of packed Red Blood Cells (pRBC) s confirmed for a minimum of 16 weeks immediately preceding C1D1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will test if combining Lenalidomide and Luspatercept will help treat anemia in patients with lower-risk Myelodysplastic Syndrome.

Who is the study for?

Adults with lower-risk Myelodysplastic Syndrome (MDS) who haven't responded to or can't take Erythropoiesis-stimulating agents, and need regular blood transfusions. Participants must not be pregnant, agree to contraception if of childbearing potential, have no severe medical conditions or recent major surgeries, and cannot have had certain prior treatments like stem cell transplants.Check my eligibility

What is being tested?

The trial is testing whether combining two drugs, Luspatercept and Lenalidomide (referred to as L2), is effective in treating anemia in patients with MDS that doesn't involve chromosome 5q deletion. The study aims to see if this drug combo improves upon current anemia treatments.See study design

What are the potential side effects?

Potential side effects for these medications may include fatigue, dizziness, blood clots, diarrhea or constipation. There might also be risks of more serious conditions such as hypertension or deep vein thrombosis but specifics will vary by individual.

Eligibility Criteria

Inclusion Criteria

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

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I am able to care for myself and perform daily activities.

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I have needed at least 2 blood transfusions every 8 weeks for the last 16 weeks.

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My condition did not improve with previous ESA treatment.

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My MDS is classified as very low, low, or intermediate risk with less than 5% blasts.

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I am 18 years or older and can sign the consent form.

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I have been taking a high dose of erythropoietin for at least 8 doses.

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I have received darbepoetin alpha or a similar treatment.

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I cannot use ESAs due to high erythropoietin levels (>200 U/L) and have not been treated with ESAs before.

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I need regular blood transfusions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

DLT Rate for Phase Ib

MTD/RP2D of Luspatercept combined with Lenalidomide

Percentage of participants with RBC-TI response

+1 more

Secondary outcome measures

Duration of RBC-TI

Overall Survival (OS)

Percentage of participants experiencing a progression to higher-risk MDS or AML

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Luspatercept + Lenalidomide GroupExperimental Treatment2 Interventions

Phase 1B: Luspatercept will be administered at starting dose 1.0 mg/kg and can be titrated to 1.33 and 1.75 mg/kg dependent on participant response. Lenalidomide will be administered in a dose escalation design between 3 cohorts to determine MTD (2.5 mg, 5 mg and 10 mg daily dose on a 21-day cycle). MTD will be defined as the dose level with 0 or 1 DLT out of 6 participants. MTD will be declared as the RP2D for the Phase II portion of the study. Phase II: Luspatercept will be administered at 1.0 mg/kg and can be titrated to 1.33 and 1.75 mg/kg dependent on participant response. Lenalidomide will be administered with the RP2D daily for 21 days on a 21 day cycle. Treatment with combination of Lenalidomide and Luspatercept will continue as long as a participant is deriving clinical benefit, in the opinion of the treating physician, for up to 5 years or until disease progression or treatment intolerance.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Luspatercept

2018

Completed Phase 3

~1050

Lenalidomide

2005

Completed Phase 3

~1480

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor

2,646 Previous Clinical Trials

4,131,113 Total Patients Enrolled

Mikkael Sekeres MDLead Sponsor

1 Previous Clinical Trials

37 Total Patients Enrolled

CelgeneIndustry Sponsor

637 Previous Clinical Trials

129,465 Total Patients Enrolled

Media Library

Lenalidomide (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04539236 — Phase 1 & 2

Myelodysplastic Syndrome Research Study Groups: Luspatercept + Lenalidomide Group

Myelodysplastic Syndrome Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT04539236 — Phase 1 & 2

Lenalidomide (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04539236 — Phase 1 & 2

Frequently Asked Questions

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

How many medical institutions are administering this trial?

"Currently, 7 medical sites across the United States are actively recruiting patients for this trial. Patients in Baltimore, Boston and Tampa have nearby clinics to consider, as well as other locations throughout America. To keep travel requirements minimal, it is wise to select a site closest to you if registering for participation."

Answered by AI

What clinical indications does Luspatercept address?

"Luspatercept is typically prescribed to patients after a minimum of two systemic chemotherapy treatments. Additionally, the medication can help manage amyloidosis, anemia and muscular dystrophy cases."

Answered by AI

Is the recruitment period for this test still ongoing?

"Correct. According to the information publicised on clinicaltrials.gov, this research endeavour, which was first posted on November 9th 2021 is still accepting volunteers. A total of 50 people are required for participation between 7 separate medical centres."

Answered by AI

Are there any other research endeavours that have investigated the use of Luspatercept?

"Luspatercept was first studied in 2004 at the Midwest Center for Hematology Oncology and has since seen 354 completed clinical trials. At present, 278 are actively recruiting subjects with many of these occurring in Baltimore, Maryland."

Answered by AI

What is the participation rate for this medical experiment?

"Affirmative. The clinical trial, initially posted on November 9th 2021 and last updated on September 28th 2022 can be found via the platform of clinicaltrials.gov which also confirms that it is actively recruiting for 50 participants across 7 sites."

Answered by AI

What are the chief aims of this clinical experiment?

"The principal objective of this clinical trial, measured over the course of 30 days after treatment, is to assess the Rate for Phase Ib Dose Limiting Toxicities. Secondary objectives include gauging the Percentage of participants with Erythroid Response (defined as Hematologic Improvement Erythroid Response - HI-E), determining if there has been a substantial reduction in RBC transfusions and platelet transfusions (determined by comparing pre-treatment numbers with those post-registration on study) and evaluating the proportion of individuals who achieved Red Blood Cell Transfusion Independence lasting 16 weeks (112 days)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Luspatercept and Lenalidomide (L2) in Lower-risk, Non-del(5q) MDS Patients

Mikkael Sekeres, MD 2021. "Luspatercept and Lenalidomide (L2) in Lower-risk, Non-del(5q) MDS Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04539236.

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