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Phase II Study of Lenalidomide and Darbepoetin Alfa in Myelodysplastic Syndrome (Low to Intermediate-1 Risk Category Excluding 5q Deletion)

Phase 2
18 Years
Not Enrolling

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Trial Information

Phase II Study of Lenalidomide and Darbepoetin Alfa in Myelodysplastic Syndrome (Low to Intermediate-1 Risk Category Excluding 5q Deletion)

Lenalidomide is designed to change the immune system and it may also interfere with the
development of tiny blood vessels that help support tumor growth. Therefore, in theory, it
may decrease or prevent the growth of cancer cells. Darbepoetin alfa is designed to
stimulate production of red blood cells.

If you are found to be eligible to take part in this study, you will take lenalidomide once
a day by mouth on Days 1-21. On Days 22-28, you will not take lenalidomide. Swallow
lenalidomide capsules whole with water at the same time each day. Do not break, chew or open
the capsules.

If you miss a dose of lenalidomide, take it as soon as you remember on the same day. If you
miss taking your dose for the entire day, take your regular dose the next scheduled day (do
NOT take double your regular dose to make up for the missed dose).

Due to the uncertain amount of re-absorption of lenalidomide, there will be no re-dose for
lenalidomide if you vomit the pills.

Every 28 days is called a study "cycle". Since lenalidomide may cause blood clots, you
will take aspirin every day, by mouth, unless your platelet count is too low. Darbepoetin
alfa will be given through a needle under the skin (subcutaneously) once every 2 weeks.

You will be given a drug diary. In this diary, you will record when you take the study
drugs and any side effects you may have.

During Cycle 1, you will have a study visit just before receiving lenalidomide and then once
a month for the first 3 months, then every 3 months after that. At these visits, you will
have a physical exam. Blood (about 2 tablespoons) will be drawn for routine tests. Your drug
diary will be checked and you will return the bottle of the study drug and any unused drug.
You will receive one cycle supply of lenalidomide.

At the end of the first 3 cycles, or earlier if your doctor thinks it is necessary, you
will have a bone marrow aspirate. If your doctor thinks it is necessary, you may have
additional bone marrow aspirates while on study.

You may remain on study for as long as you are benefitting. You will be taken off study if
the disease gets worse or intolerable side effects occur.

Once you are off-study, you will have an end-of-study visit. At this visit, blood (about 2
tablespoons) will be drawn for routine tests. If you are a woman who is able to have
children, a portion of this blood will be used for a blood pregnancy test.

You will be contacted by phone 30 days after you are taken off study, and then every 3
months. You will be asked about any side effects you are experiencing, any new treatments
you are having, and if you have needed any blood products. The phone call should take about
10 minutes.

This is an investigational study. Lenalidomide is FDA approved and commercially available.
Lenalidomide is approved for the treatment of patients with transfusion-dependent anemia due
to low- or intermediate-1-risk myelodysplastic syndromes associated with the chromosome 5
abnormality with or without other chromosome abnormalities. Lenalidomide is also approved
in combination with dexamethasone for the treatment of patients with multiple myeloma that
have received at least one prior therapy. Its use in this study is investigational.
Darbepoetin alfa is approved by FDA for treatment of low red blood cell in patients with
cancer and kidney disease. The use of these drugs together is considered to be
investigational. Up to 39 patients will take part in this study. All will be enrolled at
M. D. Anderson.

Inclusion Criteria:

1. Understand and voluntarily sign an informed consent form.

2. Age >/=18 years at the time of signing the informed consent form.

3. Able to adhere to the study visit schedule and other protocol requirements.

4. Have low or intermediate-1 IPSS risk category MDS (excluding 5q deletion)

5. red blood cell (RBC) transfusion-dependent anemia defined as no transfusion free
interval of >/= 56 consecutive days within the past 112 days.

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at study entry.

7. Laboratory test results within these ranges: Serum creatinine bilirubin /= 500 /uL,
Platelet count >/= 30,000/uL (untransfused)

8. Disease free of prior malignancies for >/=2 years with exception of currently treated
basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix
or breast

9. Patients who are on epoetin alfa or darbepoetin prior to enrollment will be allowed
to enroll if they have failed such therapy, failure defined as transfusion requiring
despite >/= 6 weeks of epoetin alfa at dose of 40,000 units/week and darbepoetin alfa
at dose of 150 mcg/ 2 week. No washout period will be necessary. Upon study entry
patients receiving epoetin alfa will be switched over to darbepoetin.

10. Females of childbearing potential (FCBP) must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to
and again within 24 hours of prescribing lenalidomide and 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 4 weeks before she starts taking lenalidomide. FCBP must also
agree to ongoing pregnancy testing.

11. continued from #10 Men must agree to use a latex condom during sexual contact with a
female of child bearing potential even if they have had a successful vasectomy.

Exclusion Criteria:

1. Clinically significant anemia owing to iron, B12, or folate deficiencies.

2. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.

3. Pregnant or breast feeding females. (Lactating females must agree not to breast feed
while taking lenalidomide)

4. Concomitant use of steroids will not be allowed unless used for premedication in
preparation for transfusions, treatment of hypersensitivity reaction related to
lenalidomide or any underlying medical condition other than MDS (e.g. Chronic
Obstructive Pulmonary Disease (COPD)).

5. Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study.

6. Use of any other experimental drug or therapy within 28 days of baseline.

7. Known hypersensitivity to thalidomide.

8. The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs.

9. Any prior use of lenalidomide.

10. Concurrent use of other anti-cancer agents or treatments.

11. Known positive for HIV or infectious hepatitis, type A, B or C.

12. Hypersensitivity to darbepoetin or any component of the formulation (including
polysorbate 80 and/or albumin);

13. Uncontrolled hypertension

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients With a Transfusion Independence Response

Outcome Description:

Response defined as transfusion independence (no red blood cell transfusions) for at least 8 weeks, anytime during the six 28-day cycles of therapy.

Outcome Time Frame:

Over six 28-day cycles (approximately 168 days)

Safety Issue:


Principal Investigator

Gautam Borthakur, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

July 2010

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndrome
  • Red cell transfusion independence
  • Darbepoetin alfa
  • Lenalidomide
  • CC-5013
  • Revlimid
  • Aranesp
  • Erythropoietin
  • Erythropoiesis Stimulating Protein
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia



UT MD Anderson Cancer Center Houston, Texas  77030