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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 Low- or Intermediate-1 Risk MDS and Symptomatic Anemia

Phase 3
18 Years
Not Enrolling
Anemia, Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes

Thank you

Trial Information

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 Low- or Intermediate-1 Risk MDS and Symptomatic Anemia


I. To compare the rate of major erythroid response (MER) in patients with low- or
intermediate-1-risk myelodysplastic syndromes treated with lenalidomide with vs without
epoetin alfa.


I. To compare the time to MER in patients treated with these regimens. II. To evaluate the
duration of MER in patients treated with these regimens. III. To estimate the frequency of
MER to salvage combination chemotherapy in patients who fail to experience an MER after
treatment with lenalidomide alone.

IV. To evaluate and compare the frequency of minor erythroid response in patients treated
with these regimens.

V. To investigate the mechanism and target of lenalidomide action in patients with
chromosome 5q31.1 deletion.

VI. To evaluate the frequency of cytogenetic response and progression, and the relationship
between cytogenetic pattern and erythroid response.

VII. To evaluate the frequency of bone marrow response (complete response and partial
response) in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to erythropoietin
level (=< 500 mU/mL vs > 500 mU/mL) and prior erythropoietic growth factor (yes vs no).
Patients are randomized to 1 of 2 treatment arms. Patients with del 5q31.1 karyotype are
assigned to treatment arm I.

ARM I: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21.

ARM II: Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa subcutaneously
(SC) once weekly.

In both arms, treatment repeats every 28 days for 4 courses. Patients who achieve a major
erythroid response (MER) may continue treatment beyond 4 courses in the absence of disease
progression, disease conversion to acute myeloid leukemia, or unacceptable toxicity.
Patients in arm I who fail to achieve MER or who achieve MER but relapse after 16 weeks of
treatment with lenalidomide may crossover and receive treatment in arm II.

After completion of study treatment, patients are followed for 6 months.

Inclusion Criteria:

- Documented diagnosis of 1 of the following:

- Myelodysplastic syndromes (MDS) lasting at least 3 months (MDS duration >= 3
months) according to World Health Organization (WHO) criteria or
non-proliferative chronic myelomonocytic leukemia (CMML) (white blood cells
[WBC] < 12,000/mcL)

- International prognostic scoring system (IPSS) category of low- or
intermediate-1-risk MDS as determined by cytogenetic analysis

- Cytogenetic analysis required if current bone marrow biopsy is a dry tap

- Patients with cytogenetic failure and < 10% marrow blasts are eligible

- Patients with cytogenetic failure must have prior cytogenetic results
(fluorescence in situ hybridization [FISH] is not a substitute) within 6
months after completion of the last type of MDS treatment (in this case,
growth factors are not considered a type of MDS treatment)

- Must have symptomatic anemia 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 =< 8 weeks before randomization

- For patients without the deletion 5q 31.1, must have failed treatment with an
erythropoietic growth factor OR have a low probability of response to
rhu-erythropoietin, as defined by the following:

- Prior erythropoietin failure: requires ≥ 40,000 units epoetin alfa/week for 8
weeks or equivalent dose of darbepoetin alfa for 8 weeks and failed to achieve
transfusion independence (in transfusion-dependent patients) or failed to
achieve ≥ 2 g rise in hemoglobin sustained for ≥4 weeks (in
transfusion-independent patients)

- Low erythropoietin response profile: rhu-erythropoietin and epoetin alfa-naive
patients receiving ≥ 2 U pRBC/month for ≥ 8 weeks and serum erythropoietin ≥ 500
mU/mL in the 8 weeks prior to study 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

- No documented iron deficiency

- Must have documented bone marrow iron stores (if marrow iron stain is not
available, transferrin saturation must be > 20% or serum ferritin > 100 ng/mL)

- Women must not 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 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 seizures or uncontrolled

- 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 (without platelet transfusion)

- Absolute neutrophil count (ANC) >= 500 cells/mcL (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 glutamic pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) =< 2.0 x

- Serum total bilirubin < 3.0 mg/dL

- Prior thalidomide 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
because HIV can be an alternate cause of anemia

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MER defined as sustained transfusion independence in transfusion-dependent patients or a rise in hemoglobin > 2 g/dL in transfusion-independent patients with anemia for a minimum of 8 consecutive weeks

Outcome Time Frame:

At 16 weeks

Safety Issue:


Principal Investigator

Alan List

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

January 2009

Completion Date:

Related Keywords:

  • Anemia
  • Chronic Myelomonocytic Leukemia
  • de Novo Myelodysplastic Syndromes
  • Previously Treated Myelodysplastic Syndromes
  • Anemia
  • Leukemia
  • Leukemia, Myelomonocytic, Chronic
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute



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Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin  54729
Holy Family Memorial Hospital Manitowoc, Wisconsin  54221
Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin  53081
Marshfield Clinic Cancer Care at Saint Michael's Hospital Stevens Point, Wisconsin  54481
Aurora Medical Center in Summit Summit, Wisconsin  53066
Vince Lombardi Cancer Clinic Two Rivers, Wisconsin  54241
Riverview Hospital Wisconsin Rapids, Wisconsin  54494
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida  33136
Arizona Cancer Center at University Medical Center North Tucson, Arizona  85719
Saint Luke's Mountain States Tumor Institute - Fruitland Fruitland, Idaho  83619
Kaiser Anaheim Medical Center Anaheim, California  92807
Kaiser Permanente Medical Group - Baldwin Park Baldwin Park, California  91706
Kaiser Foundation Hospital Bellflower, California  90706
Kaiser Permanente Hospital Fontana, California  92335
Kaiser Permanente - Harbor City Harbor City, California  90710
Kaiser Permanente-West Los Angeles Los Angeles, California  90034
Kaiser Permanente - Panorama City Panorama City, California  91402
Kaiser Permanente at San Diego San Diego, California  92120
Kaiser Permanente Health Care San Marcos, California  92069
Saint Luke's Mountain States Tumor Institute - Meridian Meridian, Idaho  83642
Saint Luke's Mountain States Tumor Institute - Nampa Nampa, Idaho  83686
Central DuPage Hospital Cancer Center Warrenville, Illinois  60555
Saint Luke's South Hospital Overland Park, Kansas  66213
Kansas City CCOP Prairie Village, Kansas  66208
King's Daughter's Medical Center Ashland, Kentucky  41101
Capital Region Medical Center-Goldschmidt Cancer Center Jefferson City, Missouri  65109
Heartland Hematology and Oncology Associates Incorporated Kansas City, Missouri  64118
Saint Joseph Oncology Inc Saint Joseph, Missouri  64507
Comprehensive Cancer Care PC Saint Louis, Missouri  63141
Susquehanna Cancer Center Williamsport, Pennsylvania  17701
Memorial Hospital Of Martinsville Martinsville, Virginia  24115
Pacific Medical Center-First Hill Seattle, Washington  98104
Gundersen Lutheran La Crosse, Wisconsin  54601
Saint Nicholas Hospital Madison, Wisconsin  53715
Fairbanks Memorial Hospital Fairbanks, Alaska  99701
Stanford University Hospitals and Clinics Stanford, California  94305
Siouxland Hematology Oncology Associates Sioux City, Iowa  51101
Walter Reed National Military Medical Center Bethesda, Maryland  20889
Kaiser Permanente-Mission San Diego, California  92108
IU Health Arnett Lafayette, Indiana  
Michiana Hematology Oncology PC-Mishawaka Mishawaka, Indiana  46545-1470
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa  52403
Marie Yeager Cancer Center Saint Joseph, Michigan  49085
Hematology Oncology Associates of Central New York PC East Syracuse, New York  13057
Door County Cancer Center Sturgeon Bay, Wisconsin  54235-1495
The Toledo Hospital/Toledo Children's Hospital Toledo, Ohio  43606
Genesys Regional Medical Center-West Flint Campus Flint, Michigan  48532
Sanford Bismarck Medical Center Bismarck, North Dakota  58501
Toledo Clinic Cancer Centers-Oregon Oregon, Ohio  43616
Geisinger Medical Center-Cancer Center Hazelton Hazleton, Pennsylvania  18201
Presbyterian Intercommunity Hospital Whittier, California  90602
Community Howard Regional Health Kokomo, Indiana  46904
Indiana University Health La Porte Hospital La Porte, Indiana  46350
Saint Joseph Regional Medical Center-Mishawaka Mishawaka, Indiana  46545-1470
PeaceHealth Saint Joseph Medical Center Bellingham, Washington  98225
Christiana Care Health System-Christiana Hospital Newark, Delaware  19718
Illinois Cancer Specialists-Niles Niles, Illinois  60714
Riverview Medical Center/Booker Cancer Center Red Bank, New Jersey  07701
Georgia Regents University Augusta, Georgia  30912
Marin Cancer Care Inc Greenbrae, California  94904
Toledo Clinic Cancer Centers-Bowling Green Bowling Green, Ohio  43402
Toledo Clinic Cancer Centers-Maumee Maumee, Ohio  43537-1839
Toledo Clinic Cancer Centers-Toledo Toledo, Ohio  43623
Self Regional Healthcare Greenwood, South Carolina  29646
Harrison Poulsbo Hematology and Oncology Poulsbo, Washington  98370
Aurora Cancer Care-Southern Lakes Elkhorn, Wisconsin  53121
Saint Luke's Mountain States Tumor Institute-Twin Falls Twin Falls, Idaho  83301
D N Greenwald Center Mukwonago, Wisconsin  53149
Presence Saint Mary's Hospital Kankakee, Illinois  60901
Rex Cancer Center of Wakefield Raleigh, North Carolina  27614
Marshfield Clinic Cancer Center at Sacred Heart Eau Claire, Wisconsin  54701