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A Pharmacokinetic And Pharmacodynamic Study Of Oral Lenalidomide (Revlimid) In Subjects With Low- Or Intermediate-1-Risk Myelodysplastic Syndromes

Phase 1/Phase 2
18 Years
Not Enrolling
Low- or Intermediate-1-risk Myelodysplastic Syndrome (MDS)

Thank you

Trial Information

A Pharmacokinetic And Pharmacodynamic Study Of Oral Lenalidomide (Revlimid) In Subjects With Low- Or Intermediate-1-Risk Myelodysplastic Syndromes

Inclusion Criteria:

1. Must understand and voluntarily sign an informed consent form.

2. Age ≥18 years at the time of signing the informed consent form.

3. Must be able to adhere to the study visit schedule and other protocol requirements.

4. Documented diagnosis of MDS that meets International Prognostic Scoring System (IPSS)
criteria for Low- to Intermediate-1-risk disease.

•Must have a diagnosis of low- or intermediate- risk MDS without a del 5q chromosomal
abnormality (Subjects taking 15 mg starting dose only).

5. Subjects must be able to provide adequate BM aspirate and biopsy specimens for
histopathological analysis and standard cytogenetic analysis during the screening

6. RBC transfusion-dependent anemia defined as having received ≥4 transfusions of RBCs
within 56 days of randomization or symptomatic anemia (Hgb< 9.0 g/dl).

7. Failed prior treatment with rhu-EPO (>= 30,000 U/wk x 6) or serum EPO concentration
>=500 mU/ml (Hgb < 9.0 g/dl).

8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.

9. Females of childbearing potential (FCBP) must agree to use two reliable forms of
contraception simultaneously or to practice complete abstinence from heterosexual
intercourse 1) for at least 28 days before starting study drug; 2) while
participating in the study; and 3) for at least 28 days after discontinuation from
the study. The two methods of reliable contraception must include one highly
effective method (i.e. intrauterine device [IUD], hormonal [birth control pills,
injections, or implants], tubal ligation, partner's vasectomy) and one additional
effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be
referred to a qualified provider of contraceptive methods, if needed.

Exclusion Criteria:

1. Pregnant or lactating females.

2. Prior therapy with lenalidomide.

3. Proliferative (WBC ≥12,000/µL) chronic myelomonocytic leukemia (CMML).

4. MDS secondary to treatment with radiotherapy, chemotherapy, and/or immunotherapy for
malignant or autoimmune diseases.

5. Any of the following lab abnormalities:

- Absolute neutrophil count (ANC) <500 cells/µL (0.5 x 10^9/L)

- Platelet count <50,000/µL (50 x 10^9/L)

- Serum creatinine > upper limit of normal (ULN)

- Serum SGOT/AST or SGPT/ALT >2.0 x ULN

- Serum total bilirubin >2.0 mg/dL (34 µmol/L)

6. Prior ≥grade-2 NCI CTCAE allergic reaction to thalidomide.

7. Prior desquamating (blistering) rash while taking thalidomide.

8. Subjects with ≥grade-2 neuropathy.

9. Clinically significant anemia due to factors such as iron, B12 or folate
deficiencies, autoimmune or hereditary hemolysis or gastrointestinal bleeding.

10. Use of cytotoxic chemotherapeutic agents, erythropoietin, or experimental agents
(agents that are not commercially available) for the treatment of MDS within 28 days
of the first day of study drug treatment.

11. 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.

12. 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/she participates in the study.

13. Known HIV-1 positivity.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Single-dose Area-under-the concentration-time curve (AUC0-24) for lenalidomide (its R and S- enantiomers and the enantiomers combined) (Day -7) Single-dose AUC0-5 for lenalidomide (its R- and S- enantiomers and the enantiomers combined) (Day 14)

Outcome Time Frame:

Days -7 and 14

Safety Issue:


Principal Investigator

Robert Knight, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

January 2005

Completion Date:

May 2009

Related Keywords:

  • Low- or Intermediate-1-risk Myelodysplastic Syndrome (MDS)
  • Myelodysplastic Syndromes
  • Preleukemia



H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612