A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and Granulocyt… (NCT03246529) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and Granulocyte Colony Stimulating Factor (G-CSF) as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma (MM)
United States180 participantsStarted 2018-03-23
Plain-language 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.
Who can participate
Age range18 Years – 78 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed Multiple Myeloma prior to enrolment and randomization.
✓. At least 1 week (7 days) from last induction cycle of combination/multi-agent cyto-reductive chemotherapy (e.g., KRD \[carfilzomib, lenalidomide, dexamethasone\] or VRD (e.g., bortezomib, lenalidomide, dexamethasone) or last single agent chemotherapy (e.g., lenalidomide, pomalidomide, bortezomib, dexamethasone, etc.) prior to the first dose of G-CSF for mobilization.
✓. Eligible for autologous hematopoietic stem cell transplantation according to the Investigator's discretion.
✓. The subjects should be in first or second CR (including CR and SCR) or PR (including PR and VGPR).
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
✓. Adequate organ function at screening as defined as below:
✓. Hematology:
✓. Platelet count more than 100 x10\^9/L Renal Function:
Exclusion criteria
✕. Previous history of autologous or allogeneic-Hematopoietic Cell Transplantation (HCT).