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This single arm study will evaluate the efficacy and safety of a combination of NeoRecormon, CellCept and prednisone in patients with low or moderate risk myelodysplastic syndromes (MDS). In the first phase of the study, patients will receive CellCept (1g p.o. twice daily) plus prednisone. After 3 months, if patients have not responded to treatment, NeoRecormon (30000 IU/week, s.c.) will be added to the treatment regimen. If there is no response to NeoRecormon after 6 weeks, the dose will be increased to 60000 IU/week. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mycophenolate Mofetil + Prednisone + Erythropoietin Beta | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolate mofetil | Drug | 1 gm twice daily orally until end of study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Response as Measured by the International Working Group (IWG) Criteria for Hematological Improvement | 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. | Up to approximately 2 years |
| Mean Number of Blood Transfusions Per Visit | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least One Adverse Event (AE) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barakaldo | 48903 | Spain | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Mycophenolate mofetil: 1 gm twice daily orally until end of study. Prednisone: 10 mg/day orally until end of study. Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Prednisone | Drug | 10 mg/day orally until end of study. |
|
| Erythropoietin Beta | Drug | Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks. |
|
|
| Up to approximately 2 years |
| Barcelona |
| 08003 |
| Spain |
| Barcelona | 08025 | Spain |
| Barcelona | 08035 | Spain |
| Barcelona | 08036 | Spain |
| Cadiz | 11009 | Spain |
| Madrid | 28040 | Spain |
| Palma de Mallorca | 07198 | Spain |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Mycophenolate mofetil: 1 gm twice daily orally until end of study. Prednisone: 10 mg/day orally until end of study. Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Clinical Response as Measured by the International Working Group (IWG) Criteria for Hematological Improvement | 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. | Posted | Number | percentage of participants | Up to approximately 2 years |
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| |||||||||||||||||||||||||||||||||||||
| Primary | Mean Number of Blood Transfusions Per Visit | Posted | Mean | Standard Deviation | transfusions/visit | Up to approximately 2 years |
|
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| Secondary | Percentage of Participants With at Least One Adverse Event (AE) | 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. | Posted | Number | percentage of participants | Up to approximately 2 years |
|
|
Up to approximately 2 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Mycophenolate mofetil: 1 gm twice daily orally until end of study. Prednisone: 10 mg/day orally until end of study. Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks. | 4 | 10 | 9 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Cardiac insufficiency | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Colecistitis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Achilles tendon´s break | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Rectal bleeding | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract catarrh | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Respiratory infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Herpes labialis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastroenteritis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Epigastralgia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Dyspnea on exertion | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
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| Dyspnea to great efforts | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
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| Achilles tendon´s tendinitis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Coxalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Dysthermia feeling | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Facial allergic reaction | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Occasional tightness in the chest | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Nervousness | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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| Chest injury due to fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Decompensated diabetes mellitus | Endocrine disorders | MedDRA 17.0 | Systematic Assessment |
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| Splenomegaly increase | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D011241 | Prednisone |
| C103998 | epoetin beta |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Title | Measurements |
|---|---|
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