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)
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.
Timeline
- Start
- 2018-03-23
- Primary completion
- 2020-12-22
- Completion
- 2029-09-30
Outcome
Met primary endpoint
paper Motixafortide + G-CSF enabled 92.5% to successfully meet the primary endpoint versus 26.2% with placebo + G-CSF PMID 37069359 ↗
registry analysis (superiority test); BL-8040 + G-CSF Part 2 vs Placebo + G-CSF Part 2; p <0.0001; Cochran-Mantel-Haenszel NCT03246529 ↗
release “GENESIS trial achieved statistical significance (p<0.0001) across all primary and secondary endpoints” biolinerx.com ↗
release “GENESIS研究由完成世界第一例造血干细胞移植的美国华盛顿大学牵头，结果显示莫替福肽+G-CSF组92.5%的患者成功达到主要终点” gloriabio.com ↗
Publications
- Crees ZD, Rettig MP, Jayasinghe RG, Stockerl-Goldstein K, Larson SM, Arpad I, Milone GA, Martino M, Stiff P, Sborov D, Pereira D, Micallef I, Moreno-Jimenez G, Mikala G, Coronel MLP, Holtick U, Hiemenz J, Qazilbash MH, Hardy N, Latif T, Garcia-Cadenas I, Vainstein-Haras A, Sorani E, Gliko-Kabir I, Goldstein I, Ickowicz D, Shemesh-Darvish L, Kadosh S, Gao F, Schroeder MA, Vij R, DiPersio JF. Motixafortide and G-CSF to mobilize hematopoietic stem cells for autologous transplantation in multiple myeloma: a randomized phase 3 trial. Nat Med. 2023 Apr;29(4):869-879. doi: 10.1038/s41591-023-02273-z. Epub 2023 Apr 17.
- Crees ZD, Stockerl-Goldstein K, Vainstein A, Chen H, DiPersio JF. GENESIS: Phase III trial evaluating BL-8040 + G-CSF to mobilize hematopoietic cells for autologous transplant in myeloma. Future Oncol. 2019 Nov;15(31):3555-3563. doi: 10.2217/fon-2019-0380. Epub 2019 Sep 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Motixafortide | Peptide | 1.25 mg/kg | Subcutaneous |
| Background | G-CSF | Unknown | 10 ug/kg | — |
| Comparator | G-CSF | Unknown | 10 ug/kg | — |