A Study of Lenalidomide Versus Placebo in Subjects With Transfusion Dependent Anemia in Low Risk Myelodysplastic Syndrome (MDS) Without Del 5Q (MDS-005)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01029262
First received: December 8, 2009
Last updated: July 8, 2013
Last verified: July 2013

December 8, 2009
July 8, 2013
November 2009
April 2016   (final data collection date for primary outcome measure)
Proportion of subjects that become transfusion independent. Proportion of subjects with an erythroid differentiation gene expression signature that become transfusion independent. [ Time Frame: Up to 4 years for each subject (likely to be 6 months to 2 years) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01029262 on ClinicalTrials.gov Archive Site
  • Evaluate the safety of lenalidomide versus placebo. [ Time Frame: up to 6 years from study start through follow-up ] [ Designated as safety issue: Yes ]
  • Evaluate the impact of lenalidomide therapy on health-related quality of life (HRQOL) and use of healthcare resources. [ Time Frame: up to 6 years from study start through follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Lenalidomide Versus Placebo in Subjects With Transfusion Dependent Anemia in Low Risk Myelodysplastic Syndrome (MDS) Without Del 5Q
A Phase 3, Multicenter, Placebo-Controlled Study to Compare the Efficacy and Safety of Lenalidomide vs. Placebo in Subjects With Transfusion Dependent Anemia Due to Low or Intermediate Risk MDS and Unresponsive to ESA Therapies

The purpose of this study is to investigate whether lenalidomide would reduce the number of red blood cell transfusions needed by anemic (RBC transfusion-dependent) subjects with low or intermediate-1 risk MDS without a deletion 5q chromosome abnormality. The study will also investigate the safety of lenalidomide use in these subjects. Two-thirds of the subjects will receive lenalidomide and one-third of the subjects will receive placebo (does not contain lenalidomide).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Anemia
  • Drug: Lenalidomide

    One 10 mg Lenalidomide capsule + 2 placebo capsules or (3 placebo capsules) once daily for subjects with a creatinine clearance ≥ 60 mL/min.

    Alternatively-one 5 mg Lenalidomide capsule + 2 placebo capsules (or 3 placebo capsules) once daily for subjects with a creatinine clearance between 40 and 60 mL/min.

    Subjects may take study drug for at least 168 days unless there are intolerable side effects or disease progresses. Subjects may continue study drug beyond 168 days if they have an erythroid response (increase in their hemoglobin levels and fewer transfusions administered than before starting study drug)

    Other Name: Revlimid
  • Other: Placebo
    3 placebo capsules once daily. Subjects may take study drug for at least 168 days unless there are intolerable side effects or disease progresses. Subjects may continue study drug beyond 168 days if they have an erythroid response (increase in their hemoglobin levels and fewer transfusions administered than before starting study drug)
  • Experimental: Arm #1 - Lenalidomide
    10 mg lenalidomide once daily (administered as one 10-mg lenalidomide capsule + 2 placebo capsules)
    Intervention: Drug: Lenalidomide
  • Placebo Comparator: Arm #2 - placebo
    Three placebo capsules once daily. Subjects will be randomized using a 2:1 ratio in a double-blind manner to receive oral lenalidomide 10 mg once daily or placebo once daily. Subjects will receive oral lenalidomide 10 mg once daily (one 10 mg lenalidomide capsules + 2 placebo capsule) or matching placebo once daily (3 placebo capsules).
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
228
December 2018
April 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years or older
  • Diagnosis of low or intermediate-1 risk MDS with any chromosome karyotype except del 5q[31]
  • Anemia that requires red blood cell transfusions
  • Resistant to erythropoiesis stimulating agents (ESAs) or blood erythropoietin level > 500 mU/mL
  • ECOG Performance Status ≤ 2
  • Must agree to follow pregnancy precautions as required by the protocol.
  • Must agree to receive counseling related to teratogenic and other risks of lenalidomide
  • Must agree not to donate blood or semen
  • Must be willing to consent to two or more bone marrow aspirate procedures to be completed during study

Exclusion Criteria:

  • Subjects previously receiving immunomodulating or immunosuppressive agents, or epigenetic or DNA modulation agents
  • Allergic reaction to thalidomide
  • Renal insufficiency (CrC1<40 mL/min by Cockroft-Gault method)
  • Prior history of cancer, other than MDS, unless the subject has been free of the disease for ≥ 5 years. (Basal cell carcinoma of the skin, Carcinoma in situ of the cervix, or stage T1a or T1b prostate cancer is allowed)
  • Absolute neutrophil count < 500/uL
  • Platelets < 50,000/uL
  • AST or ALT > 3X upper limit of normal
  • Uncontrolled hyperthyroidism or hypothyroidism
  • Significant neuropathy
  • Prior stem cell transplantation
  • Anemia due to reasons other than MDS
  • History of deep venous thrombosis (DVT) or pulmonary embolus (PE) within past 3 years
  • Significant active cardiac disease within the past 6 months
  • Known HIV infection; known Hepatitis C infection or active Hepatitis B infection
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Israel,   Italy,   Japan,   Poland,   Portugal,   Spain,   Turkey,   United Kingdom
 
NCT01029262
CC-5013-MDS-005
Yes
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: Bouchra Benettaib, MD Celgene Corporation
Celgene Corporation
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP