Lenalidomide +/− Epoetin Alfa for Myelodysplastic Syndrome

Recruiting in Palo Alto (17 mi)

+567 other locations

Overseen byAmit K Verma

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies lenalidomide to see how well it works with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia. Lenalidomide may stop the growth of myelodysplastic syndrome by blocking blood flow to the cells. Colony stimulating factors, such as epoetin alfa, may increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known whether lenalidomide is more effective with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.

Research Team

Amit K Verma

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

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.

Inclusion Criteria

I haven't received any non-transfusion treatments for MDS in the last 28 days.

I am 18 years old or older.

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

See 20 more

Exclusion Criteria

Women pregnant or breastfeeding

Serious medical condition, unstable medical co-morbidity, or psychiatric illness preventing informed consent or placing subject at unacceptable risk

I have been treated with lenalidomide before.

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Treatment Details

Interventions

Epoetin Alfa (Hematopoietic Growth Factor)
Lenalidomide (Immunomodulatory Agent)

Trial OverviewThe 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.

Participant Groups

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.