NCT00044382

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2002

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2007

Completed
Last Updated

November 8, 2019

Status Verified

November 1, 2019

Enrollment Period

4.9 years

First QC Date

August 27, 2002

Last Update Submit

November 6, 2019

Conditions

Myelodysplastic Syndrome

Keywords

RevimidCC5013CC-5013

Interventions

CC-5013DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Related Publications (1)

  • List A, Kurtin S, Roe DJ, Buresh A, Mahadevan D, Fuchs D, Rimsza L, Heaton R, Knight R, Zeldis JB. Efficacy of lenalidomide in myelodysplastic syndromes. N Engl J Med. 2005 Feb 10;352(6):549-57. doi: 10.1056/NEJMoa041668.

    PMID: 15703420BACKGROUND

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2002

First Posted

August 29, 2002

Study Start

February 1, 2002

Primary Completion

January 1, 2007

Study Completion

January 30, 2007

Last Updated

November 8, 2019

Record last verified: 2019-11

Locations

US(1)