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A Phase III, Randomized, Placebo-Controlled, Multi-Centre Study Evaluating the Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-GSF as Compared to Placebo and G-CSF for thE MobilizatioN of HematopoiEtic Stem Cells for Autologous TransplantatIon in SubjectS With Multiple Myeloma - The GENESIS Study

Trial Profile

A Phase III, Randomized, Placebo-Controlled, Multi-Centre Study Evaluating the Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-GSF as Compared to Placebo and G-CSF for thE MobilizatioN of HematopoiEtic Stem Cells for Autologous TransplantatIon in SubjectS With Multiple Myeloma - The GENESIS Study

Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Aug 2018

At a glance

  • Drugs BL 8040 (Primary) ; Granulocyte colony-stimulating factors
  • Indications Stem cell mobilisation
  • Focus Registrational; Therapeutic Use
  • Acronyms GENESIS
  • Sponsors BioLineRx
  • Most Recent Events

    • 31 Aug 2018 Biomarkers information updated
    • 07 Aug 2018 According to a BioLineRx media release, top line results from the randomized part of the trial are expected in 2020.
    • 07 Aug 2018 According to a BioLineRx media release, based on the results from 11 patients from the lead in period of the trial, the Data Monitoring Committee (DMC) recommended to stop the lead-in part of the study and move to the randomized placebo-controlled part of the study.
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