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Multiple MyelomaPhase 3NCT05438043

A Study of Daratumumab

A Phase 3 study testing Daratumumab, Carfilzomib and Dexamethasone in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 92 sites in 17 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Multiple Myeloma
What is being tested?
Daratumumab, Carfilzomib and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
213 participants
Where
92 sitesin 17 countries
Study dates
15 Dec 2022to 31 Jan 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

92 sites in 17 countries.

92 sites in 17 countries

China19 sites

  • Peking Union Medical College Hospital

    Beijing, 100006

  • Beijing Chaoyang Hospital

    Beijing, 100020

  • Peking University First Hospital

    Beijing, 100034

  • Peking University People's Hospital

    Beijing, 100044

  • The First Bethune Hospital of Jilin University

    Changchun, 130021

  • West China Hospital Si Chuan University

    Chengdu, 610041

  • Fujian Medical University

    Fuzhou, 350001

  • Guangdong General Hospital

    Guangzhou, 510080

  • Nanfang Hospital

    Guangzhou, 510515

  • First Affiliated Hospital Medical School of Zhejiang University

    Hangzhou, 310020

  • First affiliated Hospital of Zhejiang University

    Hangzhou, 310020

  • Shanghai Changzheng Hospital

    Shanghai, 200003

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai, 200025

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200127

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215002

  • Tianjin cancer hospital

    Tianjin, 300060

  • Institute of Hematology and Blood Diseases Hospital

    Tianjin, 300320

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Spain17 sites

  • Hosp. Univ. Fundacion Alcorcon

    Alcorcón, 28922

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916

  • Hosp. Del Mar

    Barcelona, 08003

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Inst. Cat. Doncologia-H Duran I Reynals

    L'Hospitalet de Llobregat, 08908

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007

  • Clinica Univ. de Navarra 1

    Madrid, 28027

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Centro Integral Oncológico Clara Campal

    Madrid, 28050

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

    Murcia, 30008

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

  • Hosp. Univ. de Canarias

    San Cristóbal de La Laguna, 38320

  • Hosp. Mutua Terrassa

    Terrassa, 08221

  • Hosp. Univ. Dr. Peset

    Valencia, 46017

Other trials in Spain

Russia9 sites

  • S.P. Botkin Moscow City Clinical Hospital 1

    Moscow, 125284

  • S.P. Botkin Moscow City Clinical Hospital

    Moscow, 125284

  • Nizhniy Novgorod Region Clinical Hospital

    Nizhny Novgorod, 603126

  • Republican Hospital named by V.A.Baranova

    Petrozavodsk, 185019

  • Ryazan Regional Clinical Hospital

    Ryazan, 390003

  • Clinical Research Institute of Hematology and Transfusiology

    Saint Petersburg, 191024

  • City Hospital No.15

    Saint Petersburg, 198205

  • Saratov State Medical University

    Saratov, 410012

  • Oncology Dispensary of Komi Republic

    Syktyvkar, 167904

Other trials in Russia

United States7 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30322

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • University of Miami Sylvester Cancer Center

    Miami, Florida, 33136

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

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Barnes-jewish Hospital

    St Louis, Missouri, 63108

Other trials in United States

Brazil7 sites

  • Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP

    Campinas, 13083-888

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062 000

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000

  • Ministerio da Saude Instituto Nacional do Cancer

    Rio de Janeiro, 20230-130

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

    Rio de Janeiro, 22775 001

  • Real e Benemerita Associacao Portuguesa de Beneficencia

    São Paulo, 01323 010

  • Clinica Medica Sao Germano LTDA

    São Paulo, 04537 081

Other trials in Brazil

South Korea7 sites

  • Pusan National University Hospital

    Busan, 49241

  • National Cancer Center

    Goyang-si, 10408

  • Chonnam National University Hwasun Hospital

    Hwasun, 519-800

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

Other trials in South Korea

France4 sites

  • Centre Hospitalier Universitaire (CHU) de Caen

    Caen, 14033

  • CHU Nantes

    Nantes, 44000

  • Hopital Saint Louis

    Paris, 75010

  • Hopital Haut Leveque

    Pessac, 33604

Other trials in France

Ukraine4 sites

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

    Cherkasy, 18009

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

    Dnipro, 49102

  • MNE Regional Oncology Center

    Kharkiv, 61070

  • Vinnytsya Regional Clinical Hospital named after M.I.Pirogov

    Vinnitsa, 21018

Other trials in Ukraine

United Kingdom4 sites

  • St James University Hospital

    Leeds, LS9 7TF

  • Leicester Royal Infirmary Haematology

    Leicester, LE1 5WW

  • Royal Marsden Hospital

    Surrey, SM2 5PT

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Czechia3 sites

  • Fakultni nemocnice Brno

    Brno, 62500

  • Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni (Main)

    Pilsen, 304 60

  • Všeobecná fakultní nemocnice v

    Prague, 128 08

Other trials in Czechia

Germany3 sites

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09113

  • Asklepios Klinik Altona

    Hamburg, 22763

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

    Tübingen, 72076

Other trials in Germany

Italy2 sites

  • Universita Degli Studi di Roma Tor Vergata

    Roma, 00133

  • Sapienza University of Rome

    Roma, 00161

Other trials in Italy

Poland2 sites

  • Wojewodzki Szpital Specjalistyczny w Legnicy

    Legnica, 59-220

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-569

Other trials in Poland

Belgium1 site

  • ZAS Cadix

    Antwerp, 2030

Other trials in Belgium

Denmark1 site

  • Aarhus University Hospital

    Aarhus N, DK-8200

Other trials in Denmark

Greece1 site

  • Alexandra General Hospital of Athens

    Athens Attica, 115 28

Other trials in Greece

Turkey (Türkiye)1 site

  • Ege Universitesi Tip Fakultesi

    Izmir, 35100

Other trials in Turkey (Türkiye)

About this study

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

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.

Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DaratumumabDrug

    Also called JNJ-54767414

    Daratumumab will be administered either intravenously or subcutaneously.

  • CarfilzomibDrug

    Carfilzomib will be administered intravenously.

  • DexamethasoneDrug

    Dexamethasone will be administered either orally or intravenously.

  • LenalidomideDrug

    Lenalidomide will be administered orally.

  • PomalidomideDrug

    Pomalidomide will be administered orally.

Study groups in NCT05438043
Study groupRoleWhat they receive
DaratumumabExperimentalParticipants will receive a single dose of daratumumab 16 milligrams per kilograms (mg/kg) intravenous (IV) or 1800 mg subcutaneous (SC) infusion on Cycle 1 Day 1 (28-day cycle), as monotherapy or in combination with standards of care treatment (that is, pomalidomide and dexamethasone, lenalidomide and dexamethasone, carfilzomib and dexamethasone) or standards of care treatment alone, depending on the treatment received in the parent study. Participants who received daratumumab IV during the parent study, will have an option to switch to daratumumab SC on Day 1 of any cycle during this long-term extension study.
Receives: Drug: Daratumumab; Drug: Carfilzomib; Drug: Dexamethasone; Drug: Lenalidomide; Drug: Pomalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Serious Adverse Events (SAEs)

    Number of participants with SAEs will be reported. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product.

    Measured: 3 years 7 months

  2. Number of Participants with AEs of Special Interest (AESI)

    Number of participants with AESI, that is, reactivation of HBV infection, will be reported.

    Measured: 3 years 7 months

  3. Number of Participants with Pregnancies or Partner Pregnancies

    Number of participants with pregnancies or partner pregnancies will be reported using the appropriate pregnancy notification form.

    Measured: 3 years 7 months

  4. Number of Participants with Abnormal Pregnancies as SAE

    Number of Participants with Abnormal Pregnancies as SAE will be reported.

    Measured: 3 years 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2022
  2. Study start15 Dec 2022
  3. Primary completion31 Jan 2029 (estimated)
  4. Study completion31 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05438043
Sponsor's protocol ID
CR109200
Other IDs
54767414MMY3030, 2021-006494-33, 2022-500138-27-00
Status last verified
Sep 2026
First submitted
24 Jun 2022
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daratumumab, Carfilzomib and Dexamethasone in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 92 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in China, Spain, Russia, United States, Brazil and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Serious Adverse Events (SAEs) (time frame: 3 years 7 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05438043.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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A Study of Daratumumab (NCT05438043) | AzTrials