drugset / Trial / NCT02572492
Study of Carfilzomib in Multiple Myeloma Relapsed After High-dose Melphalan With Autologous Stem Cell Support
RandomizedParallel-groupOpen-labelTreatment
Summary
This study evaluates induction therapy with carfilzomib-cyclophosphamide-dexamethasone before salvage high-dose melphalan with autologous stem cell support (HDT) in multiple myeloma patients with relapse after HDT done at diagnosis. In addition, the study evaluates the effect of maintenance therapy after salvage HDT in multiple myeloma. After salvage HDT half of the patients receive maintenance therapy with carfilzomib/dexamethasone while the other half are observed without maintenance therapy.
Timeline
- Start
- 2015-01
- Primary completion
- 2018-04-23
- Completion
- 2019-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carfilzomib | Other / unclassified | 20 mg/m2 | Intravenous |
| Subject | Carfilzomib | Other / unclassified | 27 mg/m2 | Intravenous |
| Subject | Carfilzomib | Other / unclassified | 36 mg/m2 | Intravenous |
| Subject | Carfilzomib | Other / unclassified | 56 mg/m2 | Intravenous |
| Subject | Dexamethasone | Small molecule | 20 mg | Oral |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Oral |
| Background | Melphalan | Small molecule | 200 mg/m2 | Intravenous |