drugset
drugset / Trial / NCT04052880

Study of SubQ Dara With Dose-Attenuated Bortezomib, Lenalidomide, Dexamethasone in Elderly NDMM

NCT04052880 ↗

Phase 2 Active not recruiting 17 enrolled Larysa Sanchez Janssen, LP · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a single center, open-label, phase 2 study in elderly (age ≥ 70) subjects with newly diagnosed multiple myeloma who are transplant ineligible. Subjects will receive subcutaneous daratumumab, dose-attenuated bortezomib, revlimid, and dexamethasone until confirmed disease progression, discontinuation of study treatment due to unacceptable drug toxicity, or other reasons. Throughout the study, subjects will be monitored closely for adverse events, laboratory abnormalities, and clinical response.

Timeline

Start
2019-10-24
Primary completion
2025-05-20
Completion
2026-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.3 mg/m2 Subcutaneous
Subject Daratumumab Monoclonal antibody 1800 mg Subcutaneous
Subject Dexamethasone Small molecule 20 mg Oral
Subject Ixazomib Unknown 2.3 mg Oral
Subject Ixazomib Unknown 3 mg Oral
Subject Lenalidomide Other / unclassified 5 mg Oral
Subject Lenalidomide Other / unclassified 10 mg Oral
Subject Lenalidomide Other / unclassified 15 mg Oral

Indications

plasma cell myeloma