A Study of Daratumumab

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: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Lenalidomide; Drug: Pomalidomide; Drug: Carfilzomib; Drug: Daratumumab; Drug: Dexamethasone

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: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• Belgium
  • Antwerp, Belgium, 2030
    • Active, not recruiting
    • ZAS Cadix
• Brazil
  • Campinas, Brazil, 13083-970
    • Active, not recruiting
    • Unicamp
  • Natal, Brazil, 59062 000
    • Active, not recruiting
    • Liga Norte Riograndense Contra o Câncer
  • Porto Alegre, Brazil, 90610 000
    • Active, not recruiting
    • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
  • Rio de Janeiro, Brazil, 20230-130
    • Active, not recruiting
    • Ministerio da Saude Instituto Nacional do Cancer
  • Rio de Janeiro, Brazil, 22793 080
    • Active, not recruiting
    • COI Clinicas Oncologicas Integradas
  • São Paulo, Brazil, 01323 010
    • Recruiting
    • Real e Benemerita Associacao Portuguesa de Beneficencia
  • São Paulo, Brazil, 04537-081
    • Active, not recruiting
    • Clínica Médica São Germano S/S Ltda
• China
  • Beijing, China, 100044
    • Active, not recruiting
    • Peking University People's Hospital
  • Beijing, China, 100034
    • Completed
    • Peking University First Hospital
  • Beijing, China, 100020
    • Active, not recruiting
    • Beijing Chaoyang Hospital
  • Beijing, China, 100006
    • Active, not recruiting
    • Peking Union Medical College Hospital
  • Changchun, China, 130021
    • Active, not recruiting
    • The First Bethune Hospital of Jilin University
  • Chengdu, China, 610041
    • Active, not recruiting
    • West China Hospital Si Chuan University
  • Fuzhou, China, 350001
    • Active, not recruiting
    • Fujian Medical University
  • Guangzhou, China, 510080
    • Active, not recruiting
    • Guangdong General Hospital
  • Guangzhou, China, 510515
    • Active, not recruiting
    • Nanfang Hospital
  • Hangzhou, China, 310020
    • Active, not recruiting
    • First Affiliated Hospital of Zhejiang University
  • Hangzhou, China, 310020
    • Active, not recruiting
    • First Affiliated Hospital Medical School of Zhejiang University
  • Shanghai, China, 200003
    • Active, not recruiting
    • Shanghai Changzheng Hospital
  • Shanghai, China, 200127
    • Active, not recruiting
    • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • Shanghai, China, 200025
    • Active, not recruiting
    • Ruijin Hospital Shanghai Jiao Tong University
  • Suzhou, China, 215002
    • Active, not recruiting
    • the First Affiliated Hospital of Soochow University
  • Tianjin, China, 300320
    • Active, not recruiting
    • Institute of Hematology and Blood Diseases Hospital
  • Tianjin, China, 300060
    • Completed
    • Tianjin Cancer Hospital
  • Wenzhou, China, 325000
    • Active, not recruiting
    • The First Affiliated Hospital of Wenzhou Medical University
  • Zhengzhou, China, 450008
    • Completed
    • Henan Cancer Hospital
• Czechia
  • Brno, Czechia, 62500
    • Active, not recruiting
    • Fakultni nemocnice Brno
  • Pilsen, Czechia, 304 60
    • Active, not recruiting
    • Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni (Main)
  • Prague, Czechia, 128 08
    • Active, not recruiting
    • Všeobecná fakultní nemocnice v
• Denmark
  • Aarhus N, Denmark, DK-8200
    • Completed
    • Aarhus University Hospital
• France
  • Caen, France, 14033
    • Completed
    • Centre Hospitalier Universitaire (CHU) de Caen
  • Nantes, France, 44000
    • Completed
    • CHU Nantes
  • Paris, France, 75010
    • Active, not recruiting
    • Hopital Saint Louis
  • Pessac, France, 33604
    • Completed
    • Hopital Haut Lévêque
• Germany
  • Chemnitz, Germany, 09113
    • Active, not recruiting
    • Klinikum Chemnitz gGmbH
  • Hamburg, Germany, 22763
    • Active, not recruiting
    • Asklepios Klinik Altona
  • Tübingen, Germany, 72076
    • Completed
    • Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
• Greece
  • Athens Attica, Greece, 115 28
    • Active, not recruiting
    • Alexandra General Hospital of Athens
• Italy
  • Roma, Italy, 00133
    • Completed
    • Universita Degli Studi di Roma Tor Vergata
  • Roma, Italy, 00161
    • Completed
    • Sapienza University of Rome
• Poland
  • Legnica, Poland, 59-220
    • Active, not recruiting
    • Wojewodzki Szpital Specjalistyczny W Legnicy
  • Poznan, Poland, 60-569
    • Active, not recruiting
    • Uniwersytecki Szpital Kliniczny w Poznaniu
• Russia
  • Moscow, Russia, 125284
    • Active, not recruiting
    • S.P. Botkin Moscow City Clinical Hospital
  • Moscow, Russia, 125284
    • Active, not recruiting
    • S.P. Botkin Moscow City Clinical Hospital 1
  • Nizhny Novgorod, Russia, 603126
    • Active, not recruiting
    • Nizhniy Novgorod Region Clinical Hospital
  • Petrozavodsk, Russia, 185019
    • Active, not recruiting
    • Republican Hospital named by V.A.Baranova
  • Ryazan, Russia, 390003
    • Active, not recruiting
    • Ryazan Regional Clinical Hospital
  • Saint Petersburg, Russia, 191024
    • Active, not recruiting
    • Clinical Research Institute of Hematology and Transfusiology
  • Saint Petersburg, Russia, 198205
    • Active, not recruiting
    • City Hospital No.15
  • Saratov, Russia, 410012
    • Active, not recruiting
    • Saratov State Medical University
  • Syktyvkar, Russia, 167904
    • Active, not recruiting
    • Oncology Dispensary of Komi Republic
• South Korea
  • Busan, South Korea, 49241
    • Active, not recruiting
    • Pusan National University Hospital
  • Goyang-si, South Korea, 10408
    • Active, not recruiting
    • National Cancer Center
  • Hwasun, South Korea, 519-800
    • Active, not recruiting
    • Chonnam National University Hwasun Hospital
  • Seongnam, South Korea, 13620
    • Active, not recruiting
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03080
    • Active, not recruiting
    • Seoul National University Hospital
  • Seoul, South Korea, 06351
    • Active, not recruiting
    • Samsung Medical Center
  • Seoul, South Korea, 06591
    • Active, not recruiting
    • The Catholic University of Korea Seoul St Marys Hospital
• Spain
  • Alcorcón, Spain, 28922
    • Active, not recruiting
    • Hosp. Univ. Fundacion Alcorcon
  • Badalona, Spain, 08916
    • Active, not recruiting
    • Hosp. Univ. Germans Trias I Pujol
  • Barcelona, Spain, 08036
    • Active, not recruiting
    • Hosp Clinic de Barcelona
  • Barcelona, Spain, 08003
    • Active, not recruiting
    • Hosp. Del Mar
  • L'Hospitalet de Llobregat, Spain, 08908
    • Active, not recruiting
    • Inst. Cat. Doncologia-H Duran I Reynals
  • Madrid, Spain, 28041
    • Active, not recruiting
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28007
    • Active, not recruiting
    • Hosp. Gral. Univ. Gregorio Maranon
  • Madrid, Spain, 28034
    • Completed
    • Hosp. Univ. Ramon Y Cajal
  • Madrid, Spain, 28050
    • Completed
    • Centro Integral Oncologico Clara Campal
  • Madrid, Spain, 28027
    • Completed
    • Clinica Univ. de Navarra 1
  • Murcia, Spain, 30008
    • Completed
    • Hosp. Gral. Univ. J.M. Morales Meseguer
  • Pamplona, Spain, 31008
    • Active, not recruiting
    • Clinica Univ. de Navarra
  • Pozuelo de Alarcón, Spain, 28223
    • Active, not recruiting
    • Hosp. Quiron Madrid Pozuelo
  • Salamanca, Spain, 37007
    • Active, not recruiting
    • Hosp Clinico Univ de Salamanca
  • San Cristóbal de La Laguna, Spain, 38320
    • Active, not recruiting
    • Hosp. Univ. de Canarias
  • Terrassa, Spain, 08221
    • Active, not recruiting
    • Hosp. Mutua Terrassa
  • Valencia, Spain, 46017
    • Completed
    • Hosp. Univ. Dr. Peset
• Turkey (Türkiye)
  • Izmir, Turkey (Türkiye), 35100
    • Active, not recruiting
    • Ege Universitesi Tip Fakultesi
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Active, not recruiting
    • CNE Clinical Center of Oncology Hematology Transplantology and Palliative Care of the Cherkasy RC
  • Dnipro, Ukraine, 49102
    • Active, not recruiting
    • Municipal Non-Commercial Enterprise City Clinical Hospital No 4 of Dnipro City Council
  • Kharkiv, Ukraine, 61070
    • Active, not recruiting
    • MNE Regional Oncology Center
  • Vinnitsa, Ukraine, 21018
    • Active, not recruiting
    • Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
• United Kingdom
  • Leeds, United Kingdom, LS9 7TF
    • Active, not recruiting
    • St James University Hospital
  • Leicester, United Kingdom, LE1 5WW
    • Recruiting
    • Leicester Royal Infirmary Haematology
  • Surrey, United Kingdom, SM2 5PT
    • Active, not recruiting
    • Royal Marsden Hospital
• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Active, not recruiting
      • University of Miami Sylvester Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Active, not recruiting
      • Emory University
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Active, not recruiting
      • University of Michigan Comprehensive Cancer Center
  • Missouri
    • St Louis, Missouri, United States, 63108
      • Active, not recruiting
      • Barnes-Jewish Hospital
  • New York
    • New York, New York, United States, 10065
      • Completed
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10029
      • Completed
      • Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
  • Texas
    • Dallas, Texas, United States, 75246
      • Completed
      • Baylor University Medical Center

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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.	3 years 7 months
Number of Participants with AEs of Special Interest (AESI)	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	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	Number of Participants with Abnormal Pregnancies as SAE will be reported.	3 years 7 months

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: June 24, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Polycyclic Compounds; Piperidines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Isoindoles; Lenalidomide; Dexamethasone; carfilzomib; pomalidomide; daratumumab
• Other Study ID 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