drugset / Trial / NCT05438043
A Study of Daratumumab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma benefiting from treatment in certain Janssen Research and Development (R\&D) studies that use daratumumab as part of the study treatment regimen: access for all participants regardless of treatment group in daratumumab studies and access to participants in daratumumab-containing arms in the non-daratumumab studies will be allowed from studies which have reached clinical cutoff for final analysis. Certain long-term safety data will continue to be collected from study participants.
Timeline
- Start
- 2022-12-15
- Primary completion
- 2029-01-31
- Completion
- 2029-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daratumumab | Monoclonal antibody | 16 mg/kg | Intravenous |
| Subject | Daratumumab | Monoclonal antibody | 1800 mg | Intravenous |
| Background | Carfilzomib | Other / unclassified | — | Intravenous |
| Background | Dexamethasone | Small molecule | — | Oral |
| Background | Lenalidomide | Other / unclassified | — | Oral |
| Background | Pomalidomide | Other / unclassified | — | Oral |