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Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment With Lenalidomide (Revlimid®) Alone and in Combination With Epoetin Alfa (Procrit®) in Subjects With L

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Trial Conditions
  • Anemia
  • Chronic Myelomonocytic Leukemia
  • Leukemia
  • Myelodysplastic Syndromes
  • de Novo Myelodysplastic Syndromes
  • Previously Treated Myelodysplastic Syndromes
What is the purpose of this trial?

This randomized phase III trial studies lenalidomide to see how well it works with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia. Lenalidomide may stop the growth of myelodysplastic syndrome by blocking blood flow to the cell. Colony stimulating factors, such as epoetin alfa, may increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known whether lenalidomide is more effective with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Inclusion Criteria:

- Patient must have documented diagnosis of MDS lasting at least three months (MDS
duration >= 3 months) according to World Health Organization (WHO) criteria or
non-proliferative chronic myelomonocytic leukemia (CMML) (white blood cell [WBC] <
12,000/mcL)

- Patient must have International Prognostic Scoring System (IPSS) categories of low-
or intermediate-1-risk disease; patients must have IPSS score determined by
cytogenetic analysis prior to randomization; patients must have cytogenetic analysis
done (to calculate IPSS); if the current bone marrow biopsy is a dry tap, patients
with cytogenetic failure and < 10% marrow blasts will be eligible; subjects with
cytogenetic failure must have previous cytogenetic results (fluorescence in situ
hybridization [FISH] is not a substitute) within the last 6 months post last type of
MDS treatment (in this case, not referring to growth factors as type of MDS
treatment)

- Must have symptomatic anemia untransfused with hemoglobin < 9.5 g/dL =< 8 weeks prior
to randomization or with red blood cells (RBC) transfusion dependence (i.e., >= 2
units/month) confirmed for equal< 8 weeks before randomization

- NOTE: For non-transfusion dependent patients (i.e., receiving < 2 units/4 weeks
x 8 weeks pre-study) who receive periodic transfusions, the mean 8 week
pre-transfusion hemoglobin should be used to determine protocol eligibility and
response reference

- For non-transfusion dependent patients, a minimum of 2 pre-transfusion or
un-transfused hemoglobin values are required

- Applies only for patients without the deletion 5q 31.1; patients must have failed
treatment with an erythropoietic growth factor, or have a low probability of response
to rhu-erythropoietin; patients with low probability of response to
rhu-erythropoietin or prior erythropoietin failures are defined as follows:

- Prior erythropoietin failure-requires a minimum trial of >= 40,000 units epoetin
alfa/week x 8 weeks or equivalent dose of darbepoetin alfa for 8 weeks with
failure to achieve transfusion independence in dependent patients or a failure
to achieve a >= 2 g rise in hemoglobin sustained for >= 4 weeks in
non-transfusion dependent patients

- Low erythropoietin response profile-rhu-erythropoietin and epoetin alfa-naïve
patients receiving >= 2U packed (p)RBC/month for a minimum of 8 weeks, and serum
erythropoietin > 500 mU/mL in the 8 weeks prior to randomization for a
hemoglobin < 9.5 g/dL

- Patients must be off all non-transfusion therapy for MDS for 28 days prior to
initiation of study treatment, including all types of growth factors; patients may
receive hydrocortisone prophylactically to prevent transfusion reactions

- Patients must have a serum erythropoietin level documented before randomization and
=< 56 days before day 1 of study treatment; NOTE: hemoglobin must be < 9.5 g/dL at
time that serum erythropoietin is drawn

- Patients must not have documented iron deficiency; all patients must have documented
marrow iron stores; if marrow iron stain is not available, the transferrin saturation
must be > 20% or a serum ferritin > 100 ng/mL

- Women must not be pregnant or breastfeeding; females of childbearing potential must
have a negative serum or urine pregnancy test with a sensitivity of at least 25
mIU/mL within 10-14 days and again within 24 hours prior to starting cycle 1 of
lenalidomide; a female of childbearing potential (FCBP) is any woman, regardless of
sexual orientation or whether they have undergone tubal ligation, who meets the
following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or
2) has not been naturally postmenopausal for at least 24 consecutive months (i.e.,
has had menses at any time in the preceding 24 consecutive months; FCBP must also
agree to ongoing pregnancy testing)

- Effective contraception must be used by patients participating in lenalidomide
therapy, and all patients must agree to counseling by a trained counselor every 28
days about pregnancy precautions and risks of fetal exposure; females of childbearing
potential (FCBP) must either commit to continued abstinence from heterosexual
intercourse or begin TWO acceptable methods of birth control: one highly effective
method and one additional effective method AT THE SAME TIME, at least 28 days before
starting lenalidomide, during lenalidomide therapy, during dose interruptions, and
for at least 28 days following discontinuation of lenalidomide therapy; females of
childbearing potential should be referred to a qualified provider of contraceptive
methods, if needed; males receiving lenalidomide must agree to use a latex condom
during any sexual contact with females of childbearing potential even if they have
undergone a successful vasectomy

- Patients must not have prior therapy with lenalidomide

- Patients must not have a diagnosis of uncontrolled seizure or uncontrolled
hypertension

- Patients must not have proliferative (WBC >= 12,000/mcL) chronic myelomonocytic
leukemia (CMML); WBC must be < 12,000/mcL

- Patients must not have MDS secondary to treatment with radiotherapy, chemotherapy,
and/or immunotherapy for malignant or autoimmune diseases

- Platelet count >= 50,000/mcL (50 x 10^9/L) without platelet transfusion

- Absolute neutrophil count (ANC) >= 500 cells/mcL (0.5 x 10^9/L); hence ANC must be >=
500/mcL without myeloid growth factor support

- Serum creatinine =< 1.5 times upper limit of normal (ULN)

- Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or
serum glutamate pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) =< 2.0 x
ULN

- Serum total bilirubin < 3.0 mg/dL

- Prior thalidomide is allowed, however, patients must not have prior >= grade-3
allergic reactions to thalidomide

- Patients must not have prior history of desquamating rash from thalidomide at time of
study entry

- Patients must not have clinically significant anemia resulting from iron, B12 or
folate deficiencies, autoimmune or hereditary hemolysis, or gastrointestinal bleeding

- Patients must not have used cytotoxic chemotherapeutic agents or experimental agents
(agents that are not commercially available) for the treatment of MDS within 8 weeks
of randomization

- Patients must not have prior history of malignancy other than MDS (except basal cell
or squamous skin cell carcinoma or carcinoma in situ of the cervix or breast) unless
the subject has been confirmed free of disease for >= 3 years

- Patients must not have any serious medical condition or any other unstable medical
co-morbidity, 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

- Patients must not have a history of thrombo-embolic events within 3 years prior to
study randomization

- Patients must not have known human immunodeficiency virus (HIV)-1 seropositivity

- Patients must not have a known allergic reaction to epoetin alfa (Procrit) or human
serum albumin

- Eligibility for crossover registration from Arm A (lenalidomide alone) to Arm B
(lenalidomide and epoetin alfa):

- Patients must have completed 16 weeks of monotherapy with lenalidomide

- Patients must show failure to achieve MER (major erythroid response) or have achieved
MER but relapsed on Arm A

- Patients must not have a limiting unresolved grade 3 or greater toxicity from
lenalidomide monotherapy or drug intolerance preventing continuation of lenalidomide
treatment

Gender: Both
Steward Physician(s)
  • Alan List
Facilities
  • St. Elizabeth's Medical Center - Withdrawn
Trial Interventions
Biological
  • epoetin alfa
Drug
  • lenalidomide
Other
  • laboratory biomarker analysis
For more information about this trial, contact

Uma Narayanasami

Phone: 617-789-3000


Physician Researcher

Investigator Name:

  • Alan List

Other Information

Sponsor: National Cancer Institute (NCI)
Phase: Phase 3
Trial ID: NCT00843882
Volunteers:  Not Accepting Healthy Volunteers

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