Lenalidomide and Darbepoetin in Low-Intermediate Risk Myelodysplastic Syndrome (MDS)

This study has been terminated.
(Low accrual.)
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01222195
First received: October 14, 2010
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

The goal of this clinical research study is to learn if lenalidomide and darbepoetin alfa given together will help to control the need for transfusions in patients with low to intermediate risk Myelodysplastic Syndrome (MDS). The safety of this combination will also be studied.


Condition Intervention Phase
Leukemia
Drug: Lenalidomide
Drug: Darbepoetin alfa
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Lenalidomide and Darbepoetin Alfa in Myelodysplastic Syndrome (Low to Intermediate-1 Risk Category Excluding 5q Deletion)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Patients With a Transfusion Independence Response [ Time Frame: Over six 28-day cycles (approximately 168 days) ] [ Designated as safety issue: No ]
    Response defined as transfusion independence (no red blood cell transfusions) for at least 8 weeks, anytime during the six 28-day cycles of therapy.


Enrollment: 1
Study Start Date: February 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide + Darbepoetin alfa
Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
Drug: Lenalidomide
10 mg/day by mouth on days 1-21 of every 28 day cycle.
Other Names:
  • CC-5013
  • Revlimid
Drug: Darbepoetin alfa
200 mcg subcutaneously every 2 weeks of a 28 cycle.
Other Names:
  • Aranesp
  • Erythropoietin
  • Erythropoiesis Stimulating Protein

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 </= 1.5 mg/dL ,Total bilirubin </= 1.5 mg/dL ,AST (SGOT) and ALT (SGPT) </= 3 x ULN, ANC >/= 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01222195

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Investigators
Principal Investigator: Gautam Borthakur, MBBS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01222195     History of Changes
Other Study ID Numbers: 2006-0657
Study First Received: October 14, 2010
Results First Received: March 30, 2011
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Myelodysplastic Syndrome
Red cell transfusion independence
Darbepoetin alfa
Lenalidomide
CC-5013
Revlimid
Aranesp
Erythropoietin
Erythropoiesis Stimulating Protein

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Syndrome
Bone Marrow Diseases
Disease
Hematologic Diseases
Neoplasms
Pathologic Processes
Precancerous Conditions
Darbepoetin alfa
Epoetin alfa
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Hematinics
Hematologic Agents
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014