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An Efficacy Study for Epoetin Alfa in Anemic Patients With Myelodysplastic Syndromes

Information source: Janssen-Cilag International NV
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myelodysplastic Syndromes

Intervention: Group 2: Placebo (Drug); Group 1: Epoetin alfa (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Janssen-Cilag International NV

Official(s) and/or principal investigator(s):
Janssen-Cilag International NV Clinical Trial, Study Director, Affiliation: Janssen-Cilag International NV

Summary

The purpose of this study is to demonstrate that epoetin alfa works better than placebo in improving anemia in patients with lower-risk myelodysplastic syndromes (MDS). The safety of epoetin alfa will also be evaluated.

Clinical Details

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Epoetin Alfa Versus Placebo in Anemic Patients With IPSS Low- or Intermediate-1-Risk Myelodysplastic Syndromes

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Erythroid response

Secondary outcome:

Maintenance of Erythroid response

Duration of response

Time to first Red Blood Cell transfusion

Transfusion-free intervals

Number of Red Blood Cell units transfused

Quality of life as measured by Functional Assessment of Cancer Therapy-Anemia/Fatigue (FACT-An) questionnaire

Quality of life as measured by EuroQol 5-dimension (EQ-5D) questionnaire

Drug consumption

Duration of hospitalization

Number and duration of medical care encounters

Detailed description: This is a randomized (the treatment you receive will be assigned by chance), double-blind (neither physician nor patient knows the name of the assigned drug), placebo-controlled (comparison with patients that receive treatment without active ingredient), multicenter study of epoetin alfa in anemic patients who are diagnosed with myelodysplastic syndromes (MDS) according to protocol-specified criteria. This study includes a 2-week screening phase, a 24-week treatment phase and a 24-week treatment extension phase. All patients enrolled in the study will complete an end-of-study visit 4 weeks after the last dose of study drug (Week 28 or Week 52), or 4 weeks after early withdrawal (unless the reason for early withdrawal is withdrawal of consent). Between 125 and 159 patients will be enrolled in the treatment phase of the study. During the screening phase, which will take place within 2 weeks before starting study drug, the study doctor will do tests to see if the patient is suitable for this study. Patients meeting entry criteria for the study will then be randomly assigned to one of the 2 treatment groups. This means that each patient who is allowed to join the study is put into a group by chance, like flipping a coin. Group 1 patients will receive epoetin alfa 450 or increased up to 1050 International Units (IU) per kg body weight administered by subcutaneous injection (injection beneath the skin) using pre-filled syringes. Injections will be done once every week at a weight-based dose regimen (the total weekly dose received will depend on your weight) with a possible total maximum dose of 40,000 IU once every week for the first 8 weeks of the treatment phase and 80,000 IU once every week at any other time during the study. Group 2 patients will receive a matching volume of placebo administered once every week by subcutaneous injection. The chance that the patient will get epoetin alfa is 2 to 1. Doses of study drug will be withheld, decreased, or increased on the basis of erythroid response, weekly hemoglobin concentrations monitored in patients and predefined dose adjustment guidelines. Patients will see the study doctor every 4 weeks for a period of 24 weeks. At each visit the patient will undergo a full hematologic evaluation, serum chemistry evaluation, measurement of blood pressure and pulse rate, recording of blood product transfusions and transfusion complications, adverse events, concomitant therapies and an evaluation for disease progression. The patient's Erythroid response will be assessed at Week 8 and every 4 weeks thereafter, until Week 24. Blinded study treatment will be administered to all patients at Week 24. However, at the end of the treatment phase (after the Week 24 response assessment), only responders will enter the double-blind treatment extension phase to measure the duration of response. Patients will continue to receive the same treatment, in the same blinded fashion, and at the same dose as received at Week 24, and will return to the study center every 4 weeks, until Week 48, for assessment of the Erythroid response and the evaluations as described above. For all non-responders at Week 24 the treatment code will be broken after Week 28 assessments. For responders at Week 48, the treatment code will be broken after the Week 48 visit, following completion of the response assessment. The treatment code will not be broken for subjects who discontinue study treatment before Week 24, irrespective of whether they are responders or nonresponders. For these subjects, the blind will not be broken until all subjects have completed the study and the database is final. Once the patient stops receiving doses of study drug, he/she will be asked to see the study doctor for the safety follow-up visit, which is scheduled 4 weeks after the last dose of study drug. Safety will be monitored throughout the study at predetermined intervals and as clinically indicated by physical examination, laboratory tests and evaluation of adverse events. An Independent Data Monitoring Committee (IDMC) will periodically review study data and for the assessment of disease progression. The total duration of study participation will be for about 30 or 54 weeks.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of MDS according to World Health Organization or French-American-British

pathologic classification (confirmed via bone marrow aspirate/biopsy) within 12 weeks prior to screening

- Documentation of an International Prognostic Scoring System score indicating Low- or

Intermediate-1-risk disease within 12 weeks prior to screening

- Hemoglobin concentration at screening and baseline (before the first dose of study

drug) of 10. 0 g/dL or less

- Screening serum erythropoietin concentration of less than 500 mU/mL

- Red Blood Cell transfusion requirement of less than or equal to 4 red blood cell

units over the last 8 weeks before randomization Exclusion Criteria:

- Anemia attributed to factors other than MDS (including hemolysis, chronic renal

failure, hepatitis, gastrointestinal bleeding)

- Secondary MDS (ie, MDS arising after chemotherapy, immunotherapy or radiation

therapy/exposure)

- History of malignancy, except in situ skin basal cell carcinoma or carcinoma in situ

of the cervix or breast curatively treated

- Prior therapy with any erythropoiesis-stimulating agent (ESA) (including innovative

ESAs and biosimilar ESAs for approved indications or for investigational use) in the last 8 weeks before randomization

- Prior use of approved or experimental agents for the treatment of MDS

Locations and Contacts

Plovdiv, Bulgaria

Sofia, Bulgaria

Varna, Bulgaria

Amiens, France

Angers Cedex 9, France

Bobigny, France

Colmar, France

Paris Cedex 10, France

Pessac Cedex, France

Pierre Benite Cedex, France

Saint Priest En Jarez, France

Tours Cedex 9, France

Vandoeuvre Les Nancy, France

Berlin, Germany

Dresden, Germany

Duisburg, Germany

Düsseldorf, Germany

Dÿsseldorf, Germany

München, Germany

Oldenburg, Germany

Würzburg, Germany

Athens, Greece

Goudi-Athens, Greece

Larisa, Greece

Patra, Greece

Thessalonikis, Greece

Ekaterinburg, Russian Federation

St. Petersburg, Russian Federation

Additional Information

Starting date: October 2011
Last updated: June 25, 2015

Page last updated: August 23, 2015

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