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Epoetin Alfa

Group 1: Epoetin alfa type = range unit= IU/Kg number= 337.5 to 1050 IU/Kg form= solution for injection route= subcutaneous use weekly injections (max 40 000 IU per week for first 8 weeks of treatment max 80 000 IU per week later) using pre-filled 1mL 40 000 IU syringes for 24 to 48 weeks

Group 2: Placebo form= solution for injection route= subcutaneous use weekly injections for 24 to 48 weeks

form= solution for injection, route= subcutaneous use, weekly injections for 24 to 48 weeks

Group 2: Placebo

type = range, unit= IU/Kg, number= 337.5 to 1050 IU/Kg, form= solution for injection, route= subcutaneous use, weekly injections (max 40,000 IU per week for first 8 weeks of treatment, max 80,000 IU per week later) using pre-filled 1mL 40,000 IU syringes for 24 to 48 weeks

Group 1: Epoetin alfa

Janssen-Cilag International NV Clinical Trial

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.

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 3-week prerandomization 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.

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

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

Janssen-Cilag International NV

Behaviors and Mental Disorders

Quality of Life

epidemiologic study

Janssen-Cilag S.p.A. Clinical Trial

The purpose of this study is to evaluate the correlation between quality of life (QoL) and hemoglobin in patients affected by myelodysplastic syndrome and to compare the MDS (MyeloDisplastic Syndrome) patient's self-assessed QoL according to physician's evaluation

In low-risk Myelodysplastic Syndrome (MDS), anemia is the major clinical problem and often represents the principal cause of symptoms which negatively influence quality of life (QoL). Moreover anemia has been associated with increased cardiac disease which, in older patients, may aggravate pre-existing conditions such as congestive heart failure. Patients with MDS often require red blood cell transfusions that further deteriorate patients' perception of well-being. This is an 18-month prospective observational investigation about the Quality of Life in Myelodysplastic patients with the aim to evaluate the correlation between hemoglobin (Hb) value and QoL and to compare the MDS patient's self-assessed QoL per physician's assessment. One hundred and fifty consecutive MDS patients at diagnosis and at least one with cytopenia - low level of hemoglobin or low level of neutrophils (a type of white blood cells that fights against infection) or low level of platelets (irregularly shaped cells found in blood that help prevent bleeding) - will be included in the evaluation. Demographic and disease-specific data will be collected and QoL will be evaluated by a specific questionnaire named QoL-E which will be completed both by patients and respective physicians. Study visits will be performed monthly until week 12; the subsequent visits will be performed at 6, 12 and 18 months. No Serious Adverse Event will be collected during the study, only adverse reaction to any Janssen-Cilag drug should be reported. This information may be important to optimize treatment according to patients' preferences and expectations, to detect functional complications, as well as to improve communication between patients and caregivers. Observational study - No study drug was administered.

Survey on QUality of Life In myeloDisplasia (SQUID)

QUALITY OF LIFE ASSESSMENT IN PATIENTS AFFECTED BY MYELODYSPLASTIC SYNDROME

Janssen-Cilag S.p.A.

Intervention: early onset of Eprex60000 IU/week , at patient inclusion

Intervention: late introduction of Eprex60000 IU/week, whenever the patient reaches the level chosen RBC transfusions (based on age, comorbidities, anticipated tolerance of anemia).

EPREX

Sophie Park, Prof

Fatiha Chermat, CRA

Berengere gruson, MD

Berengere Gruson, MD

Sylvain THEPOT

Sylvain Tepot, MD

Bohrane Slama, MD

Anne Banos, MD

Elena-Catalina ENACHE, MD

Ana BERCEANU, MD

Thorsten Braun, MD

Christian Berthou, Prof

Stéphane Cheze, MD

Anne Violaine DONCKER, MD

Anaise BLOUET, MD

Benoit De RENZIS, MD

Célia Salanoubat, MD

Andrea TOMA, MD

Sophie Park, MD, PHD

Kamel Laribi, MD

Katell LE DU, MD

Christian Rose, MD

Christian Rose, Prof

Marie-Pierre Gourin, MD

Eric Wattel, MD, PHD

Norbert Vey, prof

REZA TABREZI, MD

Pierre Peterlin, MD

Thomas Cluzeau, MD

Pierre Fenaux, PHD

Pierre Fenaux, prof

Laurence Sanhes, MD

Sophie Dimicoli-Salazar, MD

Jose Miguel Torregrosa Diaz, MD

Pascale Cony-Makhoul, MD

Marius MOLDOVAN, MD

Chantal HIMBERLIN, MD

Stanislas Nimubona, MD

Aspasia Stamatoulas, MD

Aspasia Stamatoullas, MD

Elsa LESTANG, MD

Shanti NATAJARAN-AME, MD

Odile Beyne-Rauzy, Prof

Nadia ALI AMAR, MD

Jixing LIU, MD

Agnès Guerci-Bresler, MD

This is an open-label, randomized, multicenter, phase III study

Patients with baseline Hb comprised between 9 and 10.5g/dl will be randomized to receive EPO Alfa 60000 UI/week for at least 12 weeks:

* Either at diagnosis Or
* at the Hb threshold chosen for RBC transfusions (must be \< 9g/dl)

in this trial we will compare the early introduction of EPO alfa to the delayed introduction in lower risk MDS with non RBC transfusion dependent anemia.

At enrollment patients will be randomised in the 2 arms (early and delayed start of EPO alfa).

Treatment Regimen Epoetin alfa 60000 UI/week for at least 12 weeks

1. Early onset arm: early onset of EPO ALFA 60000 IU/week , at patient inclusion
2. Delayed onset arm: late introduction of EPO ALFA 60000 IU/week, whenever the patient reaches the level chosen RBC transfusions (based on age, comorbidities, anticipated tolerance of anemia).

A Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS

A Randomized Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS With Non RBC Transfusion Dependent Anemia and Without Del 5q

RBC transfusion dependence will be defined by requirement of at least transfusions of 2 PRBC within an interval of less than 8 weeks, given for Hb \<8g/dl or \<9g/dl according to comorbidities and in the absence of other cause of anemia (bleeding, surgery...), taking into account only transfusions given at least 12 weeks after onset of treatment with EPO ALFA.

Erythroid response (according to IWG 2006 criteria) after 12 weeks of EPO ALFA treatment

response duration to EPO ALFA measured from the date of enrollment until failure

Overall survival measured from the date of enrollment to death or the date of last contact

Groupe Francophone des Myelodysplasies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Efficacy Study for Epoetin Alfa in Anemic Patients With Myelodysplastic Syndromes	NCT01381809	Myelodysplastic...	Group 2: Placeb... Group 1: Epoeti...	18 Years -	Janssen-Cilag International NV
Survey on QUality of Life In myeloDisplasia (SQUID)	NCT00967564	Myelodysplastic...	epidemiologic s...	18 Years -	Janssen-Cilag S.p.A.
A Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS	NCT03223961	Myelodysplastic...	EPREX	18 Years -	Groupe Francophone des Myelodysplasies

Spots Global Cancer Trial Database for eprex

Every month we try and update this database with for eprex cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for eprex

Every month we try and update this database with for eprex cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for eprex cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.