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Immunomodulatory Agent

Lenalidomide +/− Epoetin Alfa for Myelodysplastic Syndrome

Phase 3

Waitlist Available

Led By Alan F List

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Age >= 18 years

Patient must have documented diagnosis of MDS lasting at least three months (MDS duration >= 3 months) according to World Health Organization (WHO) criteria or non-proliferative chronic myelomonocytic leukemia (CMML) (white blood cell [WBC] < 12,000/mcL)

Must not have

Prior therapy with lenalidomide

Proliferative CMML (WBC >= 12,000/mcL)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at 16 weeks

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial studies lenalidomide with or without epoetin alfa to treat patients with myelodysplastic syndrome and anemia.

Who is the study for?

Adults diagnosed with low- or intermediate-1-risk myelodysplastic syndrome (MDS) and anemia, who have not responded to erythropoietin treatment or are unlikely to respond. Participants must have adequate organ function, no severe allergies to thalidomide, no recent malignancies other than MDS, and not be pregnant. They should also not have had any MDS treatments in the last 28 days.

What is being tested?

The trial is testing whether lenalidomide works better alone or combined with epoetin alfa for treating anemia in patients with MDS. Lenalidomide may inhibit tumor growth by cutting off blood supply to cancer cells while epoetin alfa could boost immune cell numbers.

What are the potential side effects?

Lenalidomide can cause side effects like fatigue, dizziness, constipation, and risk of blood clots. Epoetin alfa might lead to high blood pressure, joint pain, and increased risk of stroke or heart attack. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have been diagnosed with MDS or CMML for at least 3 months.

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I have been diagnosed with MDS or CMML with low white blood cell count for 3 months or more.

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I have anemia with hemoglobin below 9.5 g/dL or I need blood transfusions regularly.

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I have tried erythropoietin treatment for anemia without success.

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My platelet count is at least 50,000 without recent transfusions.

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I have not responded well to treatments aimed at increasing my red blood cells.

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My blood disorder is considered low or intermediate-1 risk.

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I have been receiving blood transfusions regularly and have not used specific anemia treatments.

Exclusion Criteria

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

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I have been treated with lenalidomide before.

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My white blood cell count is 12,000/mcL or higher due to CMML.

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My MDS developed after treatment for cancer or an autoimmune disease.

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I don't have severe side effects from lenalidomide that would stop me from continuing treatment.

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I have anemia due to a deficiency or bleeding.

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I have seizures or high blood pressure that is not well-controlled.

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I haven't used any strong chemotherapy or experimental drugs for MDS in the last 8 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 16 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of Patients With Major Erythroid Response (MER)

Secondary study objectives

Association Between Major Erythroid Response and Cytogenetic Response

Duration of Major Erythroid Response (MER)

Erythropoietin

+6 more

Other study objectives

Proportion of Patients With Cryptic Chromosome 5q31.1 Deletions

RNA and Protein Expression Level of Cdc25C, PP2A and Their Phosphatase Substrates, Cdc2phospho-Tyr15 and Cdc25Cphospho-Ser216

The Association Between CD45 Isoform Profile and ex Vivo Augmentation of STAT5 Phosphorylation by Lenalidomide

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (lenalidomide, epoetin alfa)Experimental Treatment4 Interventions

Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly. Patients undergo bone marrow biopsy at screening and during follow-up. Patients undergo blood specimen collection on study.

Group II: Arm A (lenalidomide)Active Control3 Interventions

Patients receive lenalidomide PO QD on days 1-21. Patients undergo bone marrow biopsy at screening and during follow-up. Patients undergo blood specimen collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Biopsy

2021

Completed Phase 3

~230

Epoetin Alfa

2014

Completed Phase 4

~8240