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Immunomodulatory Agent

Lenalidomide +/− Epoetin Alfa for Myelodysplastic Syndrome

Q: Could you walk me through other studies that have been conducted using Lenalidomide?

To date, <a href="https://www.withpower.com/clinical-trials/lenalidomide">lenalidomide</a> has been included in 1,104 completed clinical trials since its inception at University of <a href="https://www.withpower.com/clinical-trials/wisconsin">Wisconsin</a> Carbone <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center in 2004. As of now, there are 292 active trials underway, with a significant portion of these taking place in Jefferson City, <a href="https://www.withpower.com/clinical-trials/missouri">Missouri</a>.

Q: What medical condition is Lenalidomide typically used to treat?

<a href="https://www.withpower.com/clinical-trials/lenalidomide">Lenalidomide</a> has been found to be an effective at treating <a href="https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia">chronic lymphocytic leukemia</a>, in patients that have had at two prior systemic chemotherapy regimens, and those that have undergone noncardiac surgery.

Q: What are the side effects of Lenalidomide?

<a href="https://www.withpower.com/clinical-trials/lenalidomide">Lenalidomide</a> has undergone multiple clinical trials with promising data, meaning it has been deemed safe by our team and given a score of 3.

Q: Are people with the qualifying medical condition currently being accepted into the study?

Unfortunately, this particular study is no longer recruiting patients. The trial was first posted on 1/29/2009 and was last updated on 10/11/2022. If you are exploring for other studies, there are presently 1871 clinical trials actively admitting patients with anemia and 292 studies for <a href="https://www.withpower.com/clinical-trials/lenalidomide">Lenalidomide</a> actively looking for participants.

Q: Is this study being conducted at multiple locations throughout the city?

There are 100 sites where this trial is being offered, some of which are Capital Region Southwest Campus in Jefferson City, Marin <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Care Inc in Greenbrae, and Menorah Medical Center in Overland Park.

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at 16 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Select...

My bone marrow disease is considered low or intermediate-1 risk based on a special test.

Select...

I have tried erythropoietin treatment for anemia without success.

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I haven't received any treatment for MDS except possibly hydrocortisone in the last 28 days.

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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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I get less than 2 blood transfusions in 4 weeks and will use my average hemoglobin levels from the last 8 weeks.

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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.

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

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

Primary outcome measures

Proportion of Patients With Major Erythroid Response (MER)

Secondary outcome measures

Association Between Major Erythroid Response and Cytogenetic Response

Duration of Major Erythroid Response (MER)

Erythropoietin

+6 more

Other outcome measures

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

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 2

~10

Epoetin Alfa

2014

Completed Phase 4

~7920

Lenalidomide

2005

Completed Phase 3

~1480

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,932,906 Total Patients Enrolled

Alan F ListPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Amit K VermaPrincipal InvestigatorECOG-ACRIN Cancer Research Group

1 Previous Clinical Trials

52 Total Patients Enrolled

Media Library

Lenalidomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT00843882 — Phase 3

Myelodysplastic Syndrome Research Study Groups: Arm A (lenalidomide), Arm B (lenalidomide, epoetin alfa)

Myelodysplastic Syndrome Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT00843882 — Phase 3

Lenalidomide (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00843882 — Phase 3

Frequently Asked Questions

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

Could you walk me through other studies that have been conducted using Lenalidomide?

"To date, lenalidomide has been included in 1,104 completed clinical trials since its inception at University of Wisconsin Carbone Cancer Center in 2004. As of now, there are 292 active trials underway, with a significant portion of these taking place in Jefferson City, Missouri."

Answered by AI

What medical condition is Lenalidomide typically used to treat?

"Lenalidomide has been found to be an effective at treating chronic lymphocytic leukemia, in patients that have had at two prior systemic chemotherapy regimens, and those that have undergone noncardiac surgery."

Answered by AI

What are the side effects of Lenalidomide?

"Lenalidomide has undergone multiple clinical trials with promising data, meaning it has been deemed safe by our team and given a score of 3."

Answered by AI

Are people with the qualifying medical condition currently being accepted into the study?

"Unfortunately, this particular study is no longer recruiting patients. The trial was first posted on 1/29/2009 and was last updated on 10/11/2022. If you are exploring for other studies, there are presently 1871 clinical trials actively admitting patients with anemia and 292 studies for Lenalidomide actively looking for participants."

Answered by AI

Is this study being conducted at multiple locations throughout the city?

"There are 100 sites where this trial is being offered, some of which are Capital Region Southwest Campus in Jefferson City, Marin Cancer Care Inc in Greenbrae, and Menorah Medical Center in Overland Park."

Answered by AI