drugset / Trial / NCT03871829
Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the efficacy (rate of very good partial response \[VGPR\] or better as best response as defined by the International Myeloma Working Group \[IMWG\] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab to evaluate daratumumab retreatment.
Timeline
- Start
- 2019-05-31
- Primary completion
- 2022-10-24
- Completion
- 2023-01-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daratumumab | Monoclonal antibody | 1800 mg | Subcutaneous |
| Background | Carfilzomib | Other / unclassified | 20 mg/m2 | Intravenous |
| Background | Carfilzomib | Other / unclassified | 70 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 20 mg | Intravenous |
| Background | Dexamethasone | Small molecule | 40 mg | Intravenous |