Multiple myeloma patients get continued access to daratumumab in new safety study

NCT ID NCT05438043

Ongoing Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This study provides ongoing access to daratumumab-based treatment for 500 adults with multiple myeloma who are already benefiting from it in earlier Janssen trials. The main goal is to monitor long-term safety, including serious side effects and infections. Participants continue their current treatment regimen, which may include daratumumab alone or with other drugs like lenalidomide or carfilzomib.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Daratumumab (given alone or with carfilzomib, dexamethasone, lenalidomide, or pomalidomide)
What this could lead to: If successful, this study could confirm that long-term daratumumab treatment is safe and helps keep multiple myeloma under control for extended periods.
What could go wrong: This is an extension study, not a new treatment test. It does not aim to cure the disease, and participants must already be benefiting from daratumumab. Side effects like serious infections or infusion reactions remain possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma smoldering plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MULTIPLE MYELOMA

Contacts and locations

Locations

Aarhus University Hospital

Aarhus N, DK-8200, Denmark
Alexandra General Hospital of Athens

Athens Attica, 115 28, Greece
Asklepios Klinik Altona

Hamburg, 22763, Germany
Barnes-jewish Hospital

St Louis, Missouri, 63108, United States
Baylor University Medical Center

Dallas, Texas, 75246, United States
Beijing Chaoyang Hospital

Beijing, 100020, China
CHU Nantes

Nantes, 44000, France
CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC

Cherkasy, 18009, Ukraine
COI Clinicas Oncologicas Integradas

Rio de Janeiro, 22793 080, Brazil
Centre Hospitalier Universitaire (CHU) de Caen

Caen, 14033, France
Centro Integral Oncológico Clara Campal

Madrid, 28050, Spain
Chonnam National University Hwasun Hospital

Hwasun, 519-800, South Korea
City Hospital No.15

Saint Petersburg, 198205, Russia
Clinica Medica Sao Germano S/S LTDA

São Paulo, 04537-081, Brazil
Clinica Univ. de Navarra

Pamplona, 31008, Spain
Clinica Univ. de Navarra 1

Madrid, 28027, Spain
Clinical Research Institute of Hematology and Transfusiology

Saint Petersburg, 191024, Russia
Ege Universitesi Tip Fakultesi

Izmir, 35100, Turkey (Türkiye)
Emory University

Atlanta, Georgia, 30322, United States
Fakultni nemocnice Brno

Brno, 62500, Czechia
Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni (Main)

Pilsen, 304 60, Czechia
First Affiliated Hospital Medical School of Zhejiang University

Hangzhou, 310020, China
First affiliated Hospital of Zhejiang University

Hangzhou, 310020, China
Fujian Medical University

Fuzhou, 350001, China
Guangdong General Hospital

Guangzhou, 510080, China
Henan Cancer Hospital

Zhengzhou, 450008, China
Hopital Haut Leveque

Pessac, 33604, France
Hopital Saint Louis

Paris, 75010, France
Hosp Clinic de Barcelona

Barcelona, 08036, Spain
Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain
Hosp. Del Mar

Barcelona, 08003, Spain
Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007, Spain
Hosp. Gral. Univ. J.M. Morales Meseguer

Murcia, 30008, Spain
Hosp. Mutua Terrassa

Terrassa, 08221, Spain
Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, 28223, Spain
Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain
Hosp. Univ. Dr. Peset

Valencia, 46017, Spain
Hosp. Univ. Fundacion Alcorcon

Alcorcón, 28922, Spain
Hosp. Univ. Germans Trias I Pujol

Badalona, 08916, Spain
Hosp. Univ. Ramon Y Cajal

Madrid, 28034, Spain
Hosp. Univ. de Canarias

San Cristóbal de La Laguna, 38320, Spain
Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg

New York, New York, 10029, United States
Inst. Cat. Doncologia-H Duran I Reynals

L'Hospitalet de Llobregat, 08908, Spain
Institute of Hematology and Blood Diseases Hospital

Tianjin, 300320, China
Klinikum Chemnitz gGmbH

Chemnitz, 09113, Germany
Leicester Royal Infirmary Haematology

Leicester, LE1 5WW, United Kingdom
Liga Norte Riograndense Contra O Cancer

Natal, 59062 000, Brazil
MNE Regional Oncology Center

Kharkiv, 61070, Ukraine
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Ministerio da Saude Instituto Nacional do Cancer

Rio de Janeiro, 20230-130, Brazil
Municipal Non-Commercial Enterprise City Clinical Hospital No 4 of Dnipro City Council

Dnipro, 49102, Ukraine
Nanfang Hospital

Guangzhou, 510515, China
National Cancer Center

Goyang-si, 10408, South Korea
New Cross Hospital

Wolverhampton, WV10 0QP, United Kingdom
Nizhniy Novgorod Region Clinical Hospital

Nizhny Novgorod, 603126, Russia
Oncology Dispensary of Komi Republic

Syktyvkar, 167904, Russia
Peking Union Medical College Hospital

Beijing, 100006, China
Peking University First Hospital

Beijing, 100034, China
Peking University People's Hospital

Beijing, 100044, China
Pusan National University Hospital

Busan, 49241, South Korea
Real e Benemerita Associacao Portuguesa de Beneficencia

São Paulo, 01323 010, Brazil
Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200127, China
Republican Hospital named by V.A.Baranova

Petrozavodsk, 185019, Russia
Royal Marsden Hospital

Surrey, SM2 5PT, United Kingdom
Ruijin Hospital Shanghai Jiao Tong University

Shanghai, 200025, China
Ryazan Regional Clinical Hospital

Ryazan, 390003, Russia
S.P. Botkin Moscow City Clinical Hospital

Moscow, 125284, Russia
S.P. Botkin Moscow City Clinical Hospital 1

Moscow, 125284, Russia
Samsung Medical Center

Seoul, 06351, South Korea
Sapienza University of Rome

Roma, 00161, Italy
Saratov State Medical University

Saratov, 410012, Russia
Seoul National University Bundang Hospital

Seongnam, 13620, South Korea
Seoul National University Hospital

Seoul, 03080, South Korea
Shanghai Changzheng Hospital

Shanghai, 200003, China
St James University Hospital

Leeds, LS9 7TF, United Kingdom
The Catholic University of Korea Seoul St Marys Hospital

Seoul, 06591, South Korea
The First Affiliated Hospital of Soochow University

Suzhou, 215002, China
The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000, China
The First Bethune Hospital of Jilin University

Changchun, 130021, China
Tianjin cancer hospital

Tianjin, 300060, China
UNICAMP

Campinas, 13083-970, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, 90610-000, Brazil
Universita Degli Studi di Roma Tor Vergata

Roma, 00133, Italy
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

Tübingen, 72076, Germany
University of Miami Sylvester Cancer Center

Miami, Florida, 33136, United States
University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States
Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, 60-569, Poland
Vinnytsya Regional Clinical Hospital named after M.I.Pirogov

Vinnitsa, 21018, Ukraine
Všeobecná fakultní nemocnice v

Prague, 128 08, Czechia
West China Hospital Si Chuan University

Chengdu, 610041, China
Wojewodzki Szpital Specjalistyczny w Legnicy

Legnica, 59-220, Poland
ZAS Cadix

Antwerp, 2030, Belgium

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