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

NCT01222195 | Terminated Phase 2 Results DMC

• 1 other identifier: 2006-0657
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia

Keywords

Myelodysplastic Syndrome; Red cell transfusion independence; Darbepoetin alfa; Lenalidomide; CC-5013; Revlimid; Aranesp; Erythropoietin; Erythropoiesis Stimulating Protein

Outcome Measures

Primary Outcomes (1)

• Number of Patients With a Transfusion Independence Response

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

  Over six 28-day cycles (approximately 168 days)

Study Arms (1)

Lenalidomide + Darbepoetin alfa

EXPERIMENTAL

Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle

Drug: Lenalidomide; Drug: Darbepoetin alfa

Interventions

Lenalidomide DRUG

10 mg/day by mouth on days 1-21 of every 28 day cycle.

Also known as: CC-5013, Revlimid

Lenalidomide + Darbepoetin alfa

Darbepoetin alfa DRUG

200 mcg subcutaneously every 2 weeks of a 28 cycle.

Also known as: Aranesp, Erythropoietin, Erythropoiesis Stimulating Protein

Lenalidomide + Darbepoetin alfa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and voluntarily sign an informed consent form.
• Age \>/=18 years at the time of signing the informed consent form.
• Able to adhere to the study visit schedule and other protocol requirements.
• Have low or intermediate-1 IPSS risk category MDS (excluding 5q deletion)
• red blood cell (RBC) transfusion-dependent anemia defined as no transfusion free interval of \>/= 56 consecutive days within the past 112 days.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at study entry.
• 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)
• 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
• 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.
• 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.
• 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.

You may not qualify if:

• Clinically significant anemia owing to iron, B12, or folate deficiencies.
• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide)
• 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)).
• 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.
• Use of any other experimental drug or therapy within 28 days of baseline.
• Known hypersensitivity to thalidomide.
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Any prior use of lenalidomide.
• Concurrent use of other anti-cancer agents or treatments.
• Known positive for HIV or infectious hepatitis, type A, B or C.
• Hypersensitivity to darbepoetin or any component of the formulation (including polysorbate 80 and/or albumin);
• Uncontrolled hypertension

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Celgene Corporation: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes

Interventions

Lenalidomide; Darbepoetin alfa; Erythropoietin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Results Point of Contact

• Title: Gautam Borthakur, MBBS / Assistant Professor
• Organization: The University of Texas M. D. Anderson Cancer Center

eharriso@mdanderson.org

713-792-7305

Study Officials

• Gautam Borthakur, MBBS

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 18, 2010
• Study Start: February 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 7, 2012
• Results First Posted: April 26, 2011

Record last verified: 2012-08

Locations

US (1)