A Study of NeoRecormon (Epoetin Beta), CellCept (Mycophenolate Mofetil) and Prednisone in Patients With Low or Intermediate Myelodysplastic Syndromes.
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|ClinicalTrials.gov Identifier: NCT00551291|
Recruitment Status : Completed
First Posted : October 30, 2007
Results First Posted : June 23, 2016
Last Update Posted : July 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes||Drug: Mycophenolate mofetil Drug: Prednisone Drug: Erythropoietin Beta||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Study of the Effects of a Combination of NeoRecormon, CellCept and Prednisone on Hematological Parameters and Cytogenesis in Patients With Low or Intermediate Risk Myelodysplastic Syndromes.¿|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
Experimental: Mycophenolate Mofetil + Prednisone + Erythropoietin Beta
Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.
Drug: Mycophenolate mofetil
1 gm twice daily orally until end of study.
10 mg/day orally until end of study.
Drug: Erythropoietin Beta
Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks.
Other Name: NeoRecormon
- Percentage of Participants With Clinical Response as Measured by the International Working Group (IWG) Criteria for Hematological Improvement [ Time Frame: Up to approximately 2 years ]International Working Group (IWG) criteria for hematological improvement was defined as having hemoglobin (Hgb) <11 g/dL (pretreatment) and an increase in Hgb ≥1.5 g/dL after ≥8 weeks of treatment.
- Mean Number of Blood Transfusions Per Visit [ Time Frame: Up to approximately 2 years ]
- Percentage of Participants With at Least One Adverse Event (AE) [ Time Frame: Up to approximately 2 years ]An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551291
|Barakaldo, Spain, 48903|
|Barcelona, Spain, 08003|
|Barcelona, Spain, 08025|
|Barcelona, Spain, 08035|
|Barcelona, Spain, 08036|
|Cádiz, Spain, 11009|
|Madrid, Spain, 28040|
|Palma de Mallorca, Spain, 07198|
|Study Director:||Clinical Trials||Hoffmann-La Roche|