NCT03277105: Phase 3 - Subcutaneous vs Intravenous daratumumab in relapsed MM - COLUMBA study
Updated: Jun 21, 2022
A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough).
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03277105
Official Title: A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma
First Posted : September 8, 2017
Click here for details on ClinicalTrials.gov
Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial
PMID: 32213342 ; Lancet Haematol; May 2020
Subcutaneous daratumumab in Asian patients with heavily pretreated multiple myeloma: subgroup analyses of the noninferiority, phase 3 COLUMBA study.
Ann Hematol. 2021 Apr
Greater treatment satisfaction in patients receiving daratumumab subcutaneous vs. intravenous for relapsed or refractory multiple myeloma: COLUMBA clinical trial results.
J Cancer Res Clin Oncol. 2021 Feb
Drug: Dara SC
Drug: Dara IV
- North Carolina: Levine Cancer Institute Charlotte
- Massachusetts: Dana-Farber Cancer Institute/Harvard Cancer Center Boston
United States, Massachusetts
United States, North Carolina
Canada, British Columbia
Canada, Nova Scotia
Korea, Republic of