A Study to Evaluate Dara-CyBorD in Previously Untreated and Relapsed Subjects With Multiple Myeloma

Phase 2 Completed 101 enrolled Janssen Scientific Affairs, LLC

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate complete response plus (+) very good partial response (CR+VGPR) rate following 4 cycles of induction therapy of daratumumab in combination with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD), in previously untreated subjects, and in relapsed subjects with multiple myeloma, as defined by the International Myeloma Working Group (IMWG) criteria.

Timeline

Start: 2016-11-09
Primary completion: 2018-03-08
Completion: 2020-08-17

Publications

Yimer H, Melear J, Faber E, Bensinger WI, Burke JM, Narang M, Stevens D, Gray KS, Lutska Y, Bobba P, Qi K, Hoehn D, Qi M, Lin TS, Rifkin RM. Daratumumab, cyclophosphamide, bortezomib, and dexamethasone for multiple myeloma: final results of the LYRA study. Leuk Lymphoma. 2022 Oct;63(10):2383-2392. doi: 10.1080/10428194.2022.2076847. Epub 2022 Jun 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daratumumab	Monoclonal antibody	16 mg/kg	Intravenous
Background	Bortezomib	Small molecule	1.5 mg/m2	Subcutaneous
Background	Cyclophosphamide	Other / unclassified	300 mg/m2	Oral
Background	Dexamethasone	Small molecule	—	—

A Study to Evaluate Dara-CyBorD in Previously Untreated and Relapsed Subjects With Multiple Myeloma

Summary

Timeline

Publications

Drugs

Indications