Efficacy of Daratumumab in Patients With Relapsed/Refractory Myeloma With Renal Impairment

Phase 2 Completed 38 enrolled Hellenic Society of Hematology Janssen Pharmaceuticals · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study was to evaluate the effects of daratumumab with dexamethasone (DaraD) in subjects with relapsed or refractory multiple myeloma and renal impairment.

Timeline

Start: 2018-02-15
Primary completion: 2021-03-22
Completion: 2021-03-22

Publications

Kastritis E, Terpos E, Symeonidis A, Labropoulou V, Delimpasi S, Mancuso K, Zamagni E, Katodritou E, Rivolti E, Kyrtsonis MC, Roussou M, Fotiou D, Theodorakakou F, Ntanasis-Stathopoulos I, Hatjiharissi E, Kanellias N, Migkou M, Cheliotis G, Manousou K, Gavriatopoulou M, Dimopoulos MA. Prospective phase 2 trial of daratumumab with dexamethasone in patients with relapsed/refractory multiple myeloma and severe renal impairment or on dialysis: The DARE study. Am J Hematol. 2023 Sep;98(9):E226-E229. doi: 10.1002/ajh.27001. Epub 2023 Jun 21. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daratumumab	Monoclonal antibody	16 mg/kg	Intravenous
Background	Dexamethasone	Small molecule	20 mg	Oral
Background	Dexamethasone	Small molecule	40 mg	Oral

Efficacy of Daratumumab in Patients With Relapsed/Refractory Myeloma With Renal Impairment

Summary

Timeline

Publications

Drugs

Indications