RecruitingPhase 3NCT05438043

A Study of Daratumumab

A Phase 3b, Multicenter, Open-label, Daratumumab Long-term Extension Study


Sponsor

Janssen Research & Development, LLC

Enrollment

500 participants

Start Date

Dec 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma benefiting from treatment in certain Janssen Research and Development (R\&D) studies that use daratumumab as part of the study treatment regimen: access for all participants regardless of treatment group in daratumumab studies and access to participants in daratumumab-containing arms in the non-daratumumab studies will be allowed from studies which have reached clinical cutoff for final analysis. Certain long-term safety data will continue to be collected from study participants.


Eligibility

Plain Language Summary

Simplified for easier understanding

This is a continuation (rollover) study that allows patients with multiple myeloma (a type of blood cancer) or smoldering multiple myeloma who have been receiving daratumumab in a previous Janssen clinical trial to keep getting treatment if they are still benefiting from it, even after the original trial has ended. **You may be eligible if:** - You are currently receiving daratumumab (alone or with other treatments) in a specific Janssen research study - Your cancer has not progressed and you haven't had unacceptable side effects - Your doctor believes you are still benefiting from the treatment - Your last dose of study treatment was within the past 3 months **You may NOT be eligible if:** - You have experienced disease progression or serious side effects from daratumumab - You are not currently enrolled in a qualifying Janssen parent study - You have met the withdrawal criteria from the original study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDaratumumab

Daratumumab will be administered either intravenously or subcutaneously.

DRUGCarfilzomib

Carfilzomib will be administered intravenously.

DRUGDexamethasone

Dexamethasone will be administered either orally or intravenously.

DRUGLenalidomide

Lenalidomide will be administered orally.

DRUGPomalidomide

Pomalidomide will be administered orally.


Locations(91)

University of Miami Sylvester Cancer Center

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Barnes-jewish Hospital

St Louis, Missouri, United States

Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Baylor University Medical Center

Dallas, Texas, United States

ZAS Cadix

Antwerp, Belgium

UNICAMP

Campinas, Brazil

Liga Norte Riograndense Contra O Cancer

Natal, Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, Brazil

Ministerio da Saude Instituto Nacional do Cancer

Rio de Janeiro, Brazil

COI Clinicas Oncologicas Integradas

Rio de Janeiro, Brazil

Real e Benemerita Associacao Portuguesa de Beneficencia

São Paulo, Brazil

Clinica Medica Sao Germano S/S LTDA

São Paulo, Brazil

Peking Union Medical College Hospital

Beijing, China

Beijing Chaoyang Hospital

Beijing, China

Peking University First Hospital

Beijing, China

Peking University People's Hospital

Beijing, China

The First Bethune Hospital of Jilin University

Changchun, China

West China Hospital Si Chuan University

Chengdu, China

Fujian Medical University

Fuzhou, China

Guangdong General Hospital

Guangzhou, China

Nanfang Hospital

Guangzhou, China

First Affiliated Hospital Medical School of Zhejiang University

Hangzhou, China

First affiliated Hospital of Zhejiang University

Hangzhou, China

Shanghai Changzheng Hospital

Shanghai, China

Ruijin Hospital Shanghai Jiao Tong University

Shanghai, China

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

The First Affiliated Hospital of Soochow University

Suzhou, China

Tianjin cancer hospital

Tianjin, China

Institute of Hematology and Blood Diseases Hospital

Tianjin, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Henan Cancer Hospital

Zhengzhou, China

Fakultni nemocnice Brno

Brno, Czechia

Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni (Main)

Pilsen, Czechia

Všeobecná fakultní nemocnice v

Prague, Czechia

Aarhus University Hospital

Aarhus N, Denmark

Centre Hospitalier Universitaire (CHU) de Caen

Caen, France

CHU Nantes

Nantes, France

Hopital Saint Louis

Paris, France

Hopital Haut Leveque

Pessac, France

Klinikum Chemnitz gGmbH

Chemnitz, Germany

Asklepios Klinik Altona

Hamburg, Germany

Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

Tübingen, Germany

Alexandra General Hospital of Athens

Athens Attica, Greece

Universita Degli Studi di Roma Tor Vergata

Roma, Italy

Sapienza University of Rome

Roma, Italy

Wojewodzki Szpital Specjalistyczny w Legnicy

Legnica, Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland

S.P. Botkin Moscow City Clinical Hospital 1

Moscow, Russia

S.P. Botkin Moscow City Clinical Hospital

Moscow, Russia

Nizhniy Novgorod Region Clinical Hospital

Nizhny Novgorod, Russia

Republican Hospital named by V.A.Baranova

Petrozavodsk, Russia

Ryazan Regional Clinical Hospital

Ryazan, Russia

Clinical Research Institute of Hematology and Transfusiology

Saint Petersburg, Russia

City Hospital No.15

Saint Petersburg, Russia

Saratov State Medical University

Saratov, Russia

Oncology Dispensary of Komi Republic

Syktyvkar, Russia

Pusan National University Hospital

Busan, South Korea

National Cancer Center

Goyang-si, South Korea

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

Seoul National University Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, South Korea

Hosp. Univ. Fundacion Alcorcon

Alcorcón, Spain

Hosp. Univ. Germans Trias I Pujol

Badalona, Spain

Hosp. Del Mar

Barcelona, Spain

Hosp Clinic de Barcelona

Barcelona, Spain

Inst. Cat. Doncologia-H Duran I Reynals

L'Hospitalet de Llobregat, Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, Spain

Clinica Univ. de Navarra 1

Madrid, Spain

Hosp. Univ. Ramon Y Cajal

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Centro Integral Oncológico Clara Campal

Madrid, Spain

Hosp. Gral. Univ. J.M. Morales Meseguer

Murcia, Spain

Clinica Univ. de Navarra

Pamplona, Spain

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, Spain

Hosp Clinico Univ de Salamanca

Salamanca, Spain

Hosp. Univ. de Canarias

San Cristóbal de La Laguna, Spain

Hosp. Mutua Terrassa

Terrassa, Spain

Hosp. Univ. Dr. Peset

Valencia, Spain

Ege Universitesi Tip Fakultesi

Izmir, Turkey (Türkiye)

CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC

Cherkasy, Ukraine

Municipal Non-Commercial Enterprise City Clinical Hospital No 4 of Dnipro City Council

Dnipro, Ukraine

MNE Regional Oncology Center

Kharkiv, Ukraine

Vinnytsya Regional Clinical Hospital named after M.I.Pirogov

Vinnitsa, Ukraine

St James University Hospital

Leeds, United Kingdom

Leicester Royal Infirmary Haematology

Leicester, United Kingdom

Royal Marsden Hospital

Surrey, United Kingdom

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NCT05438043


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