Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome

A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00044382

Enrollment

Registered

2002-08-29

Start date

2002-02-01

Completion date

2007-01-30

Last updated

2019-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndrome

Keywords

Revimid, CC5013, CC-5013

Brief summary

To estimate the percent of patients with myelodysplastic syndromes (MDS) who experience erythroid response and the interval to response with daily treatment of 25 mg of CC-5013 .

Interventions

DRUGCC-5013

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of de novo myelodysplastic syndrome of at least 12 weeks duration. * Baseline mean hemoglobin \< 10.0 g/dL (untransfused) and/or be transfusion dependent defined by requiring at least 4 units of RBC in the 8 weeks prior to baseline. * More than 30 days must have elapsed since any previous treatment for MDS, other than transfusion. * Women must not be pregnant or lactating * No use of another experimental study drug within 30 dy\\ays of baseline * Understand and sign written informed consent * Able to adhere to study visit schedule, understand and comply with other protocol requirements.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026