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  1. A randomized phase 3 study of lenalidomide versus placebo in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with del5q

    ... 69) or 5 mg/day days 1-28 (n = 69) of 28-day cycles; or placebo (n = 67). Crossover to lenalidomide or higher dose was allowed ... (TI) for ≥ 26 weeks (primary endpoint) versus placebo (56.1% and 42.6% vs 5.9%; both P < .001). Median duration of RBC-TI was ...

    Research Article last updated 07/20/2018 - 5:14pm.

  2. Eltrombopag versus placebo for low-risk myelodysplastic syndromes with thrombocytopenia (EQoL-MDS): phase 1 results of a single-blind, randomised, controlled, phase 2 superiority trial.

    ... (2:1) to receive eltrombopag (50 mg to 300 mg) or placebo for at least 24 weeks and until disease progression and were masked ... the eltrombopag group versus one (3%) of 31 patients in the placebo group (odds ratio 27·1 [95% CI 3·5-211·9], p=0·0017). During the ...

    Research Article last updated 02/21/2017 - 9:49am.

  3. Randomized Phase III Study of Lenalidomide Versus Placebo in RBC Transfusion-Dependent Patients With Lower-Risk Non-del(5q) Myelodysplastic Syndromes and Ineligible for or Refractory to Erythropoiesis-Stimulating Agents

    ... PURPOSE: This international phase III, randomized, placebo -controlled, double-blind study assessed the efficacy and safety of ... assigned (2:1) to treatment with lenalidomide (n = 160) or placebo (n = 79) once per day (on 28-day cycles). The primary end point was the ...

    Research Article last updated 07/18/2016 - 10:30am.

  4. Outcomes in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with isolated deletion 5q treated with lenalidomide: a subset analysis from the MDS-004 study

    ... or 5 mg/day (days 1-28; n = 43) on 28-day cycles, or placebo (n = 45). From the placebo and lenalidomide 5 mg groups, 84% and 58% of patients, respectively, ...

    Research Article last updated 07/20/2018 - 5:15pm.

  5. Clinical consequences of iron overload in patients with myelodysplastic syndromes: the case for iron chelation therapy

    ... data support a survival benefit of using ICT in MDS. The placebo -controlled TELESTO trial ( NCT00940602 ) is currently examining ...

    Research Article last updated 07/18/2018 - 8:41am.

  6. Long-term effect of the complement inhibitor eculizumab on kidney function in patients with paroxysmal nocturnal hemoglobinuria.

    ... in CKD stage (P < 0.001) compared with baseline and to placebo (P = 0.04). Improvement in renal function was more commonly seen ...

    Research Article last updated 07/20/2018 - 5:14pm.

  7. A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS)

    ... 1:1 ratio (175 into the eltrombopag arm and 175 into the placebo arm). Approximately 55 subjects will be enrolled into the ... This is a randomized, double-blind, parallel group, placebo-controlled study designed to explore the platelet supportive care ...

    Clinical Trial last updated 04/27/2016 - 1:28pm.

  8. The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low

    ... Azacitidine plus Best Supportive care versus Placebo and Best Supportive care in subjects with red blood cell ... daily, First 21 days of each 28-day cycle Drug: Placebo Placebo, First 21 days of each 28-day cycle ...

    Clinical Trial last updated 04/27/2016 - 9:52am.

  9. GVAX vs. Placebo for MDS/AML After Allo HSCT

    ... be "randomized" to receive either GVAX vaccination or placebo (a saline solution) vaccination. Randomization means that you are ... receive the GVAX vaccine and a 50% chance you will receive placebo. Neither you nor your transplant doctor(s) will know which you will be ...

    Clinical Trial last updated 04/28/2016 - 12:01pm.

  10. A phase 3 randomized placebo-controlled trial of darbepoetin alfa in patients with anemia and lower-risk myelodysplastic syndromes

    ... 24 weeks of subcutaneous darbepoetin alfa 500 μg or placebo every 3 weeks (Q3W), followed by 48 weeks of open-label darbepoetin ... 5-24 was significantly lower with darbepoetin alfa versus placebo (36.1% [35/97] versus 59.2% [29/49], P=0.008] and erythroid response ...

    Research Article last updated 07/11/2017 - 10:16am.