A Phase 1/2 interventional study of Bortezomib in Myelodysplastic Syndromes, sponsored by Groupe Francophone des Myelodysplasies. Completed at 15 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-07.
Sponsored by Groupe Francophone des Myelodysplasies · Phase 1/2, Interventional, and Treatment
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 :
Cycles 2, 3, 4 :
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
1,317 studies on the registry are indexed under Preleukemia; 57 are open to participants now.
This study's enrollment of 45 is above the median of 36 across 1,060 interventional studies indexed under Preleukemia.
Browse Preleukemia studies →Groupe Francophone des Myelodysplasies is the lead sponsor of 43 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Complete Response
Partial Response
Efficacy and safety evaluation
A total of 138 cycles were administered. The median number of cycles administered was 3·2 (range 0·5-8). Thirty-six patients (84%) received at least two cycles and 17 (40%) received the planned four cycles, six responding patients received 1-4 additional cycles. Treatment was dis- continued in the responding patients at progression to AML or for toxicity. The most common treatment-related adverse events were related to myelosuppression . Neutropenia (Grade 4) and thrombocytopenia (Grade 4) were seen during treatment in 51% and 46% of the patients, respectively. Three of the patients with pre-treatment Grade 0-2 neutropenia and thrombocytopenia developed Grade 3-4 toxicity complicated by infection and bleeding. Grade 3-4 neutropenia was responsible for infection in six patients. Grade 3-4
Time frame: 18 mois
Hematological Improvement
This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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Groupe Francophone des Myelodysplasies