NCT03277105: Phase 3 - Subcutaneous vs Intravenous daratumumab in relapsed MM - COLUMBA study
Updated: Jun 21, 2022
COLUMBA study
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).
Sponsor
Janssen Research & Development, LLC
Multiple Locations
International study
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
Locations
United States, Massachusetts
United States, North Carolina
South America
Brazil
Australia
Canada, Alberta
Canada, British Columbia
Canada, Nova Scotia
Canada, Ontario
Canada, Quebec
Europe
United Kingdom
Czechia
France
Greece
Italy
Poland
Spain
Sweden
Ukraine
Asia
Israel
Japan
Korea, Republic of
Russian Federation
Taiwan