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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

columba study

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



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