drugset / Trial / NCT01749514
Study of Luspatercept for the Treatment of Anemia in Patients With Myelodysplastic Syndrome (MDS) (MK-6143-001)
Non-randomizedSequentialOpen-labelTreatment
Summary
The purpose of this study is to evaluate the effects of luspatercept (MK-6143, formerly called ACE-536) on anemia in patients with low or intermediate-1 risk myelodysplastic syndrome (MDS). There is no primary hypothesis in this study.
Timeline
- Start
- 2013-01-21
- Primary completion
- 2018-10-22
- Completion
- 2018-10-22
Publications
- Platzbecker U, Gotze KS, Kiewe P, Germing U, Mayer K, Radsak M, Wolff T, Chromik J, Sockel K, Oelschlagel U, Haase D, Illmer T, Al-Ali HK, Silling G, Reynolds JG, Zhang X, Attie KM, Shetty JK, Giagounidis A. Long-Term Efficacy and Safety of Luspatercept for Anemia Treatment in Patients With Lower-Risk Myelodysplastic Syndromes: The Phase II PACE-MDS Study. J Clin Oncol. 2022 Nov 20;40(33):3800-3807. doi: 10.1200/JCO.21.02476. Epub 2022 Aug 23.
- Platzbecker U, Germing U, Gotze KS, Kiewe P, Mayer K, Chromik J, Radsak M, Wolff T, Zhang X, Laadem A, Sherman ML, Attie KM, Giagounidis A. Luspatercept for the treatment of anaemia in patients with lower-risk myelodysplastic syndromes (PACE-MDS): a multicentre, open-label phase 2 dose-finding study with long-term extension study. Lancet Oncol. 2017 Oct;18(10):1338-1347. doi: 10.1016/S1470-2045(17)30615-0. Epub 2017 Sep 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Luspatercept | Protein / enzyme biologic | 0.125 mg/kg | Subcutaneous |
| Subject | Luspatercept | Protein / enzyme biologic | 0.25 mg/kg | Subcutaneous |
| Subject | Luspatercept | Protein / enzyme biologic | 0.5 mg/kg | Subcutaneous |
| Subject | Luspatercept | Protein / enzyme biologic | 0.75 mg/kg | Subcutaneous |
| Subject | Luspatercept | Protein / enzyme biologic | 1 mg/kg | Subcutaneous |
| Subject | Luspatercept | Protein / enzyme biologic | 1.33 mg/kg | Subcutaneous |
| Subject | Luspatercept | Protein / enzyme biologic | 1.75 mg/kg | Subcutaneous |