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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Anemia

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Proportion of subjects that become transfusion independent. Proportion of subjects with an erythroid differentiation gene expression signature that become transfusion independent.

Outcome Time Frame:

Up to 4 years for each subject (likely to be 6 months to 2 years)

Safety Issue:

No

Principal Investigator

Bouchra Benettaib, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-5013-MDS-005

NCT ID:

NCT01029262

Start Date:

November 2009

Completion Date:

December 2018

Related Keywords:

  • Anemia
  • Myelodysplastic Syndromes
  • MDS
  • transfusion dependent anemia
  • Erythropoiesis stimulating agents
  • non-del 5q
  • Anemia
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Medical College of Wisconsin, Froedtert HospitalMilwaukee, Wisconsin  53226
(853) University of California Los Angeles Medical CenterLos Angeles, California  90095
(858) Southern Illinois Hematology OncologyCentralia, Illinois  62801
(851) Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
(857) Hackensack University Medical CenterHackensack, New Jersey  07601
(852) Columbia University Medical CenterNew York, New York  10032
(855) University of Texas, MD Anderson Cancer CenterHouston, Texas  77030