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)
Active, enrolledPhase 3Results postedLast updated 15 January 2026
What this trial tests
Phase 3 trial testing BL-8040 1.25 mg/kg + G-CSF in Multiple Myeloma in 180 participants. Participants enrolled and being followed up; not accepting new ones.
Adults 18 to 78, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Subjects Mobilizing ≥6 × 10^6 CD34+ Cells/kg With up to 2 Apheresis SessionsPrimary· From first day of study treatment (G-CSF) until day of second apheresis which was planned to occur on Day 6
Percentage of subjects mobilizing ≥6 × 10\^6 CD34+ cells/kg with up to 2 apheresis sessions in preparation for autologous hematopoetic cell transplantation (auto-HCT) after treatment with G-CSF + single administration of BL-8040/placebo.
Based on central laboratory data.
Central Lab
Group
Value
95% CI
BL-8040 + G-CSF Part 2
70.0
Placebo + G-CSF Part 2
14.3
Local Lab
Group
Value
95% CI
BL-8040 + G-CSF Part 1
91.7
BL-8040 + G-CSF Part 2
92.5
Placebo + G-CSF Part 2
26.2
Percentage of Subjects Mobilizing ≥2 × 10^6 CD34+ Cells/kg in 1 Apheresis SessionSecondary· From first day of study treatment (G-CSF) until day of first apheresis which was planned to occur on Day 5
Percentage of subjects mobilizing ≥2 × 10\^6 CD34+ cells/kg in 1 apheresis session after treatment with G-CSF + single administration of BL-8040/ placebo.
Central Lab
Group
Value
95% CI
BL-8040 + G-CSF Part 2
87.5
Placebo + G-CSF Part 2
47.6
Local Lab
Group
Value
95% CI
BL-8040 + G-CSF Part 1
100
BL-8040 + G-CSF Part 2
96.3
Placebo + G-CSF Part 2
64.3
Percentage of Subjects Mobilizing ≥6 × 10^6 CD34+ Cells/kg in 1 Apheresis SessionSecondary· From first day of study treatment (G-CSF) until day of first apheresis which was planned to occur on Day 5
Percentage of subjects mobilizing ≥6 × 10\^6 CD34+ cells/kg in 1 apheresis session after treatment with G-CSF + single administration of BL-8040/ placebo.
Central Lab
Group
Value
95% CI
BL-8040 + G-CSF Part 2
67.5
Placebo + G-CSF Part 2
4.8
Local Lab
Group
Value
95% CI
BL-8040 + G-CSF Part 1
75
BL-8040 + G-CSF Part 2
88.8
Placebo + G-CSF Part 2
9.5
Time to Neutrophil Engraftment, After Auto-HCTSecondary· End of engraftment period, which was defined as 29 days post transplantation
Time to neutrophil engraftment after auto-HCT, where engraftment was defined as absolute neutrophil count (ANC) ≥0.5 × 10\^9/L for 3 days or ≥1.0 × 10\^9/L for 1 day following the conditioning regimen associated nadir.
Group
Value
95% CI
BL-8040 + G-CSF Part 1
12
11 – 12
BL-8040 + G-CSF Part 2
12
11 – 12
Placebo + G-CSF Part 2
12
11 – 12
Time to Platelet Engraftment, After Auto-HCTSecondary· End of engraftment period, which was defined as 29 days post transplantation
Time to platelet engraftment, after auto-HCT, where engraftment was defined as the first of 3 consecutive measurements of platelet count ≥20 × 10\^9/L without platelet transfusion support for 7 days following the conditioning regimen associated nadir.
Group
Value
95% CI
BL-8040 + G-CSF Part 1
17
15.0 – 20.0
BL-8040 + G-CSF Part 2
18
17 – 19
Placebo + G-CSF Part 2
17
17 – 18
Subjects With Graft Durability at 100 Days Post Transplant/ Early TerminationSecondary· Day 100 Post-Transplantation (± 7 days)
Subjects achieving graft durability were defined as meeting the following 2 criteria:
* Platelet count ≥50 × 10\^9/L without transfusion for at least 2 weeks.
* Hemoglobin level ≥10 g/dL with no erythropoietin support or transfusions for at least 1 month.
This analysis was performed in part 2 of the study only.
Group
Value
95% CI
BL-8040 + G-CSF Part 2
92.2
Placebo + G-CSF Part 2
91.9
Graft Durability at 6 Months Post TransplantationSecondary· 6 Months Post Transplantation
Comparability of the graft durability between the BL-8040 + G-CSF arm and the placebo + G-CSF arm at 6 months post transplantation
Group
Value
95% CI
BL-8040 + G-CSF Part 2
80.5
Placebo + G-CSF Part 2
83.8
Graft Durability at 9 Months Post TransplantationSecondary· 9 Months Post Transplantation
Comparability of the graft durability between the BL-8040 + G-CSF arm and the placebo + G-CSF arm at 9 months post transplantation
Group
Value
95% CI
BL-8040 + G-CSF Part 2
83.1
Placebo + G-CSF Part 2
81.1
Graft Durability at 12 Months Post TransplantationSecondary· 12 Month Post Transplantation
Comparability of the graft durability between the BL-8040 + G-CSF arm and the placebo + G-CSF arm at 12 months post transplantation
Group
Value
95% CI
BL-8040 + G-CSF Part 2
81.8
Placebo + G-CSF Part 2
81.1
Adverse events — posted to ClinicalTrials.gov
Time frame: All Adverse Events (AEs) were collected after subjects signed the ICF and up to 30 days from the last dose of study therapy (G-CSF+BL-8040/Placebo)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
BL-8040 + G-CSF Part 1
Serious: 1/12 (8%)
Deaths: 0/12
BL-8040 + G-CSF (Part 2)
Serious: 7/80 (9%)
Deaths: 2/80
Placebo + G-CSF (Part 2)
Serious: 0/42 (0%)
Deaths: 1/42
Serious adverse events (9 terms)
Reaction
System
BL-8040 + G-CSF Part 1
BL-8040 + G-CSF (Part 2)
Placebo + G-CSF (Part 2)
Injection site reaction
General disorders
—
—
—
Hypersensitivity
Immune system disorders
—
—
—
Bacteremia
Infections and infestations
—
—
—
Injection site cellulitis
Infections and infestations
—
—
—
Platelet count decreased
Investigations
—
—
—
Bladder neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma
· Phase 1
· recruiting
NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma
· Phase 1
· recruiting
NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma
· Phase 2
· recruiting
NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma
· Phase 2
· recruiting
NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With
· Phase 3
· recruiting
Other BioLineRx, Ltd. trials
Trials by the same sponsor.
NCT05293171 — Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects
· Phase 1
· completed
NCT03154827 — Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab for Maintenance Treatment in Subjects With Acute Myelo
· Phase 1, PHASE2
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BioLineRx, Ltd.
Last refreshed: 15 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03246529.