At a glance
ClinicalIndex Comparison RecordPhase 3Active· 180 enrolled
Drug / intervention
BL-8040 1.25 mg/kg + G-CSF +1 moredrug
Likely dose
BL-8040 1.25 mg/kg + G-CSFfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Placebo-Controlled, Multi-Centre Study Evaluating the Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-CSF 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
In Brief
A Phase 3 clinical trial evaluating BL-8040 1.25 mg/kg + G-CSF and Placebo +G-CSF for Multiple Myeloma. Active but no longer recruiting, targeting 180 participants across 18 sites in 5 countries.
Detailed Summary
A total of 122 subjects were randomized into the study and investigated in the double-blind placebo-controlled setting to assess the efficacy and safety of G-CSF + BL-8040 as compared to G-CSF + placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesGermany, Hungary, Italy, Spain, United States
Collaborators--
Timeline
Phase 3Active
2018201920202021202220232024202520262027202820292030
First PostedAug 2017
Enrollment StartMar 2018
Primary CompletionDec 2020
TodayJul 2026
Study CompletionSep 2029
First PostedAug 11, 2017
Enrollment StartMar 23, 2018
Primary CompletionDec 22, 2020
Study CompletionSep 30, 2029
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 8.9 years ago
Interventions
BL-8040 1.25 mg/kg + G-CSFdrug
Up to 2 subcutaneous (SC) injections of BL-8040 are anticipated during the study. Injections of G-CSF per standard of care
Placebo +G-CSFdrug
Up to 2 SC injections of Placebo are anticipated during the study. Injections of G-CSF per standard of care