BI-K

The purpose of the study was to evaluate the efficacy of ASP0113 compared with placebo as measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD) through 1 year post-transplant. Safety of ASP0113 in participants undergoing allogeneic HCT will also be evaluated.

The main objectives of this trial are: 1.) Demonstration of non-inferiority of VCD induction therapy compared to PAd induction therapy with respect to response rate (very good partial remission or better; response criteria of the International Myeloma Working Group, IMWG).

2.) Determination of the best of four treatment strategies with respect to progression-free survival (PFS). The four treatment strategies are defined by PAd vs. VCD induction treatment, standard intensification therapy, ...

Study Design The study included a lenalidomide cohort and a background cohort. Patients in both cohorts had received ≥ 1 prior antimyeloma therapy and were required to have never received lenalidomide. Enrolled patients who were treated on the study with lenalidomide for off-label indications were kept in the study. To achieve a patient population reflective of those treated in real-world clinical practice, there were few restrictions on eligibility. Exclusion criteria were refusal to participate ...

Brief Summary 5-azacytidine treatment prolongs survival in patients with myelodysplastic syndrome (MDS), but does not cure the disease. Allogeneic stem cell transplantation is a curative treatment option but is associated with a high risk treatment-related morbidity and mortality. In the current trial allogeneic stem cell transplantation will be compared to 5-azacytidine only treatment according to donor availability in elderly patients with MDS (55-70 years).

Detailed Description ...