drugset / Trial / NCT03289299
Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant
Phase 2
Active not recruiting
87 enrolled
International Myeloma Foundation
Amgen · collabCelgene Corporation · collabJanssen Scientific Affairs, LLC · collabTrevie, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
This study evaluates the use of carfilzomib, lenalidomide, daratumumab, and dexamethasone in subjects with high-risk smoldering multiple myeloma (SMM). Subjects will receive treatment in 3 phases - induction (6 cycles), consolidation (6 cycles), and maintenance (12 cycles). Each cycle is 28 days.
Timeline
- Start
- 2018-05-25
- Primary completion
- 2023-09-26
- Completion
- 2031-11-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carfilzomib | Other / unclassified | 56 mg/m2 | Intravenous |
| Subject | Daratumumab | Monoclonal antibody | 16 mg/kg | Intravenous |
| Subject | Dexamethasone | Small molecule | 20 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 10 mg | Oral |