NCT03301220: Phase 3: A Study of Subcutaneous Daratumumab Versus Active Monitoring in HI Risk SMM

NCT03301220: Phase 3: A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma

A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma

The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM).

Sponsor

Janssen Research & Development, LLC

Multiple Locations

International Study

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ClinicalTrials.gov Identifier: NCT03301220

Official Title: A Phase 3 Randomized, Multicenter Study of Subcutaneous Daratumumab Versus Active Monitoring in Subjects With High-Risk Smoldering Multiple Myeloma

First Posted : October 4, 2017

Click here for details on ClinicalTrials.gov

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Drug: Daratumumab SC: daratumumab + rHuPH20

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Locations

United States, Arizona

United States, California

United States, Florida

United States, Georgia

United States, Iowa

United States, Louisiana

United States, Massachusetts

United States, Michigan

United States, Minnesota

United States, Missouri

United States, Nevada

United States, New York

United States, North Carolina

United States, Ohio

United States, Oregon

United States, Pennsylvania

United States, Texas

United States, Washington

Mexico

Canada, Alberta

Canada, Ontario

Argentina

Brazil

Europe

United Kingdom

Czechia

Denmark

France

Germany

Greece

Italy

Netherlands

Norway

Poland

Sweden

Spain

Belgium

Hungary

Russian Federation

Asia

Turkey

Israel

Japan

Australia