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

NCT ID NCT05438043

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

213 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must be actively receiving daratumumab (either as monotherapy or in combination with other study treatment) in certain Janssen research and development (R\&D) studies or receiving other study treatment in a Janssen R\&D daratumumab study for participants with multiple myeloma or smoldering multiple myeloma which has reached clinical cutoff for final analysis continue to benefit from study treatment, not have experienced disease progression or unmanageable toxicity while receiving daratumumab, not have met the withdrawal criteria set forth in the parent study, and have had the last dose of study treatment within the previous 3 months * Investigator's assessment that the benefit of continued study treatment will outweigh the risks * A female participant of childbearing potential must have a negative pregnancy test at screening and must agree to further serum or urine pregnancy tests during the study * A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 3 months after receiving the last dose of study treatment * Must sign an informed consent form (ICF; or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study * Willing and able to adhere to the lifestyle restrictions specified in this protocol Exclusion Criteria: * Has taken any disallowed therapies or treatment for the disease under study between the completion of the parent study and the planned first dose of study treatment * Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments * Known allergies, hypersensitivity, or intolerance to study treatments or their excipients (refer to the daratumumab investigator brochure (IB) and local country prescribing information for dexamethasone, carfilzomib, pomalidomide, and lenalidomide) * Vaccinated with an investigational vaccine (except for Coronavirus disease \[COVID-19\])or live attenuated or replicating viral vector vaccines within 4 weeks prior to enrollment

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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

  • 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 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

  • Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP

    Campinas, 13083-888, Brazil

  • 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

  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

    Rio de Janeiro, 22775 001, Brazil

  • 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

  • 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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