Lenalidomide Versus Placebo in Myelodysplastic Syndromes With a Deletion 5q- Abnormality - Full Text View

Sponsors and Collaborators:	Celgene Corporation ICON Clinical Research
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00179621

Purpose

Patients are randomised to one of two treatment groups or to placebo and take treatment for 16 weeks. At this timepoint patients are evaluated for response, and if not responding they are entered into open label treatment with active drug. All responders continue in double blind treatment for 52 weeks, and if still responding then move to open label treatment for a further two years. All responders may stay in the study for three years.

Condition	Intervention	Phase
Myelodysplastic Syndromes	Drug: Lenalidomide	Phase III

MedlinePlus related topics: Blood Transfusion and Donation

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of the Efficacy and Safety of 2 Doses of Lenalidomide Versus Placebo in Red Blood Cell (RBC) Transfusion-Dependent Subjects With Low- or Intermediate-1-Risk Myelodysplastic Syndromes Associated With a Deletion 5Q Cytogenetic Abnormality

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

RBC transfusion independence at 16 weeks

Secondary Outcome Measures:

Erythroid response, major and minor
Duration of RBC transfusion independence
Change in Hb concentration
Erythroid response at one year
Change in platelet counts from baseline
Change in absolute neutrophil counts from baseline
Cytogenetic response
Bone marrow response
Safety
Quality of Life

Estimated Enrollment:	162
Study Start Date:	December 2004
Estimated Study Completion Date:	August 2010

Detailed Description:

Patients enter screening according to the inclusion/exclusion criteria and are randomised within 56 days if eligible. After 16 weeks double blind treatment, patient response is evaluated. Patients who are responding remain in the double blind phase for up to one year. Non-responders can enter an open label phase taking Revlimid at a dose determined by their treatment during the double blind phase. At all stages of the study, drug dose can be reduced if toxicity is seen. Primary endpoint is red blood cell transfusion independence for 16 weeks. All patients are able to continue on open label treatment after the first year of the study for a further two years (total three years).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must understand and voluntarily sign an informed consent form
Age 18 years at the time of signing the informed consent form
Documented diagnosis of MDS that meets IPSS criteria for low to intermediate-1-risk disease and has an associated del 5q(31) cytogenetic abnormality
RBC transfusion dependent anaemia defined as not having any 56 days without a RBC transfusion within at least the immediate 112 days
Must be able to adhere to the study visit schedule and other protocol requirements
Women of childbearing potential must have a negative pregnancy test prior to inclusion

Exclusion Criteria:

Pregnant or lactating females
Prior therapy with lenalidomide
Proliferative (WBC = 12,000/mL) chronic myelomonocytic leukemia (CMML)
Prior >= grade-2 NCI CTCAE (v 3.0) allergic reaction to thalidomide
Prior desquamating (blistering) rash while taking thalidomide
Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for >3 years
Use of cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within 28 days
Less than 6 months since prior allogeneic bone marrow transplantation
Less than 3 months since prior autologous bone marrow or stem cell transplantation
Less than 28 days since prior myelosuppressive anticancer biologic therapy
Recombinant human erythropoietin (rHuEPO) therapy received within 28 days Known HIV-1 positivity
Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he or she participates in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179621

Show 38 Study Locations

Sponsors and Collaborators

Celgene Corporation

ICON Clinical Research

More Information

Study ID Numbers:	CC-5013-MDS-004
Study First Received:	September 10, 2005
Last Updated:	July 16, 2007
ClinicalTrials.gov Identifier:	NCT00179621
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

MDS
transfusion dependent
anaemia
cytogenetic abnormality 5q-
erythroid response

leukaemia
CC-5013
Celgene
revlimid
lenalidomide

Study placed in the following topic categories:

Myelodysplastic syndromes
Chromosomal abnormalities
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Myelodysplasia
Anemia

Lenalidomide
Leukemia
Preleukemia
Chromosome Aberrations
Congenital Abnormalities
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms
Disease
Pathologic Processes
Antineoplastic Agents

Therapeutic Uses
Syndrome
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009