A Study of Daratumumab

August 27, 2026 updated by: Janssen Research & Development, LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Daratumumab activity has been observed in multiple myeloma studies of daratumumab intravenous (IV) and subcutaneous (SC) monotherapy and combination therapy. Daratumumab (JNJ-54767414) is a first-in-class, human Immunoglobulin G1 kappa (IgG1 kappa) monoclonal antibody (mAb) that specifically binds to the cell surface molecule cluster of differentiation 38 (CD38). Daratumumab binds CD38 expressing cells with high affinity in a variety of hematological malignancies, including myeloma, lymphomas, and leukemias, as well as other cell types and tissues with various expression levels, including aberrant plasma cells in systemic light chain amyloid light chain (AL) amyloidosis. This study will provide ongoing access to study treatments for participants with multiple myeloma who are actively receiving daratumumab in a Janssen R&D-sponsored daratumumab study. Participants will continue with the current study treatment dosing regimen established in the parent study. The study will consist of screening phase (up to 6 weeks), treatment phase (28-day cycle) and end of treatment visit 30 days after last dose of study treatment. Safety should be monitored and evaluated according to local institutional standard of care. Safety evaluations and adverse events (AEs) should be documented in the source medical record. Collection of serious adverse events (SAEs), pregnancies, and reports of HBV reactivation will continue until the End of Treatment (EOT) Visit 30 days after the last dose of study treatment or until the start of subsequent anti-cancer therapy, if earlier. The total duration of the study is 3 years 7 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
213

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2030
        • ZAS Cadix
  • Brazil
      • Campinas, Brazil, 13083-888
        • Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
      • Natal, Brazil, 59062 000
        • Liga Norte Riograndense Contra O Cancer
      • Porto Alegre, Brazil, 90610-000
        • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
      • Rio de Janeiro, Brazil, 20230-130
        • Ministerio da Saude Instituto Nacional do Cancer
      • Rio de Janeiro, Brazil, 22775 001
        • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
      • São Paulo, Brazil, 04537 081
        • Clinica Medica Sao Germano LTDA
      • São Paulo, Brazil, 01323 010
        • Real e Benemerita Associacao Portuguesa de Beneficencia
  • China
      • Beijing, China, 100044
        • Peking University People's Hospital
      • Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, China, 100020
        • Beijing Chaoyang Hospital
      • Beijing, China, 100006
        • Peking Union Medical College Hospital
      • Changchun, China, 130021
        • The First Bethune Hospital of Jilin University
      • Chengdu, China, 610041
        • West China Hospital Si Chuan University
      • Fuzhou, China, 350001
        • Fujian Medical University
      • Guangzhou, China, 510080
        • Guangdong General Hospital
      • Guangzhou, China, 510515
        • Nanfang Hospital
      • Hangzhou, China, 310020
        • First affiliated Hospital of Zhejiang University
      • Hangzhou, China, 310020
        • First Affiliated Hospital Medical School of Zhejiang University
      • Shanghai, China, 200003
        • Shanghai Changzheng Hospital
      • Shanghai, China, 200127
        • Renji Hospital, Shanghai Jiaotong University School of Medicine
      • Shanghai, China, 200025
        • Ruijin Hospital Shanghai Jiao Tong University
      • Suzhou, China, 215002
        • The First Affiliated Hospital of Soochow University
      • Tianjin, China, 300060
        • Tianjin Cancer Hospital
      • Tianjin, China, 300320
        • Institute of Hematology and Blood Diseases Hospital
      • Wenzhou, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
      • Zhengzhou, China, 450008
        • Henan Cancer Hospital
  • Czechia
      • Brno, Czechia, 62500
        • Fakultni nemocnice Brno
      • Pilsen, Czechia, 304 60
        • Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni (Main)
      • Prague, Czechia, 128 08
        • Všeobecná fakultní nemocnice v
  • Denmark
      • Aarhus N, Denmark, DK-8200
        • Aarhus University Hospital
  • France
      • Caen, France, 14033
        • Centre Hospitalier Universitaire (CHU) de Caen
      • Nantes, France, 44000
        • CHU Nantes
      • Paris, France, 75010
        • Hopital Saint Louis
      • Pessac, France, 33604
        • Hopital Haut Lévêque
  • Germany
      • Chemnitz, Germany, 09113
        • Klinikum Chemnitz gGmbH
      • Hamburg, Germany, 22763
        • Asklepios Klinik Altona
      • Tübingen, Germany, 72076
        • Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
  • Greece
      • Athens Attica, Greece, 115 28
        • Alexandra General Hospital of Athens
  • Italy
      • Roma, Italy, 00133
        • Universita Degli Studi di Roma Tor Vergata
      • Roma, Italy, 00161
        • Sapienza University of Rome
  • Poland
      • Legnica, Poland, 59-220
        • Wojewodzki Szpital Specjalistyczny w Legnicy
      • Poznan, Poland, 60-569
        • Uniwersytecki Szpital Kliniczny W Poznaniu
  • Russia
      • Moscow, Russia, 125284
        • S.P. Botkin Moscow City Clinical Hospital
      • Moscow, Russia, 125284
        • S.P. Botkin Moscow City Clinical Hospital 1
      • Nizhny Novgorod, Russia, 603126
        • Nizhniy Novgorod Region Clinical Hospital
      • Petrozavodsk, Russia, 185019
        • Republican Hospital named by V.A.Baranova
      • Ryazan, Russia, 390003
        • Ryazan Regional Clinical Hospital
      • Saint Petersburg, Russia, 191024
        • Clinical Research Institute of Hematology and Transfusiology
      • Saint Petersburg, Russia, 198205
        • City Hospital No.15
      • Saratov, Russia, 410012
        • Saratov State Medical University
      • Syktyvkar, Russia, 167904
        • Oncology Dispensary of Komi Republic
  • South Korea
      • Busan, South Korea, 49241
        • Pusan National University Hospital
      • Goyang-si, South Korea, 10408
        • National Cancer Center
      • Hwasun, South Korea, 519-800
        • Chonnam National University Hwasun Hospital
      • Seongnam, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 06591
        • The Catholic University of Korea Seoul St Marys Hospital
  • Spain
      • Alcorcón, Spain, 28922
        • Hosp. Univ. Fundacion Alcorcon
      • Badalona, Spain, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona, Spain, 08003
        • Hosp. Del Mar
      • Barcelona, Spain, 08036
        • Hosp Clinic de Barcelona
      • L'Hospitalet de Llobregat, Spain, 08908
        • Inst. Cat. Doncologia-H Duran I Reynals
      • Madrid, Spain, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spain, 28034
        • Hosp. Univ. Ramon Y Cajal
      • Madrid, Spain, 28007
        • Hosp. Gral. Univ. Gregorio Maranon
      • Madrid, Spain, 28050
        • Centro Integral Oncologico Clara Campal
      • Madrid, Spain, 28027
        • Clinica Univ. de Navarra 1
      • Murcia, Spain, 30008
        • Hosp. Gral. Univ. J.M. Morales Meseguer
      • Pamplona, Spain, 31008
        • Clinica Univ. de Navarra
      • Pozuelo de Alarcón, Spain, 28223
        • Hosp. Quiron Madrid Pozuelo
      • Salamanca, Spain, 37007
        • Hosp Clinico Univ de Salamanca
      • San Cristóbal de La Laguna, Spain, 38320
        • Hosp. Univ. de Canarias
      • Terrassa, Spain, 08221
        • Hosp. Mutua Terrassa
      • Valencia, Spain, 46017
        • Hosp. Univ. Dr. Peset
  • Turkey (Türkiye)
      • Izmir, Turkey (Türkiye), 35100
        • Ege Universitesi Tip Fakultesi
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC
      • Dnipro, Ukraine, 49102
        • Municipal Non-Commercial Enterprise City Clinical Hospital No 4 of Dnipro City Council
      • Kharkiv, Ukraine, 61070
        • MNE Regional Oncology Center
      • Vinnitsa, Ukraine, 21018
        • Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • St James University Hospital
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary Haematology
      • Surrey, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital
  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University Of Michigan Comprehensive Cancer Center
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Barnes-Jewish Hospital
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Daratumumab
Participants 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.
Drug: Lenalidomide
Lenalidomide will be administered orally.
Drug: Pomalidomide
Pomalidomide will be administered orally.
Drug: Carfilzomib
Carfilzomib will be administered intravenously.
Drug: Daratumumab
Daratumumab will be administered either intravenously or subcutaneously.
Other Names:
  • JNJ-54767414
Drug: Dexamethasone
Dexamethasone will be administered either orally or intravenously.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: 3 years 7 months
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.
3 years 7 months
Number of Participants with AEs of Special Interest (AESI)
Time Frame: 3 years 7 months
Number of participants with AESI, that is, reactivation of HBV infection, will be reported.
3 years 7 months
Number of Participants with Pregnancies or Partner Pregnancies
Time Frame: 3 years 7 months
Number of participants with pregnancies or partner pregnancies will be reported using the appropriate pregnancy notification form.
3 years 7 months
Number of Participants with Abnormal Pregnancies as SAE
Time Frame: 3 years 7 months
Number of Participants with Abnormal Pregnancies as SAE will be reported.
3 years 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR109200
  • 2021-006494-33 (EudraCT Number)
  • 2022-500138-27-00 (Registry Identifier: EUCT number)
  • 54767414MMY3030 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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