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Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes

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ClinicalTrials.gov Identifier: NCT00411905
Recruitment Status : Unknown
Verified December 2006 by Groupe Francophone des Myelodysplasies.
Recruitment status was:  Recruiting
First Posted : December 15, 2006
Last Update Posted : March 12, 2007
Information provided by:

December 14, 2006
December 15, 2006
March 12, 2007
June 2006
Not Provided
  • Complete Response
  • Partial Response
Same as current
Complete list of historical versions of study NCT00411905 on ClinicalTrials.gov Archive Site
Hematological Improvement
Same as current
Not Provided
Not Provided
Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes
Phase I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes
We are evaluating the efficacy of the association of Low dose Cytarabine in association with Bortezomib in the treatment of patients diagnosed with high risk Myelodysplastic syndromes. Our aim is to decrease transfusion requirements and if possible induce a complete or at least a partial remission.

Four cycles of treatment are proposed at 28 day intervals in an ambulatory setting

Cycle 1 :

  • Cytarabine 10 mg /m2/day subcutaneous injection for 14 days
  • Bortézomib 1,5mg/m2 days 1,4,8,11

Cycles 2, 3, 4 :

  • Cytarabine 20 mg /m2/j subcutaneous injections for 14 days
  • Bortézomib 1,5mg/m2 days 1,4,8,11

Bone marrow aspirates are evaluated just before the first cycle, after the second and after the fourth cycles

Responding patients may continue the treatment for 2 further cycles

Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Myelodysplastic Syndromes
Drug: Bortezomib
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
June 2006
Not Provided

Inclusion Criteria:

  • MDS with IPSS scores Int-2 or High
  • Life expectancy greater than 6 months
  • No other available treatment options

Exclusion Criteria:

  • MDS with IPSS scores Low or Int-1
  • > 30% bone marrow blasts
  • clinical neuropathy of greater than grade 2
  • ECOG Score 3 or 4
  • Creatinine clearance of < 30 ml/min
  • LMMC
  • Pregnant patients or lactating mothers
  • Patients having received intensive chemotherapy in the 3 months prior to inclusion
  • Patients with uncontrolled pulmonary, cardiac, neurological, gastro-intestinal or genito-urinary disorders
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
GFM BAR-C-2005
Not Provided
Not Provided
Not Provided
Groupe Francophone des Myelodysplasies
Not Provided
Principal Investigator: Francois DREYFUS, MD PhD Groupe francaise des Myelodysplasies
Groupe Francophone des Myelodysplasies
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP