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RECRUITING

NCT05438043

PHASE3

A Study of Daratumumab

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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 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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2022-12-15

Completion Date

2029-01-31

Last Updated

2026-03-16

Healthy Volunteers

Conditions

Multiple Myeloma

Interventions

DRUG

Daratumumab

Daratumumab will be administered either intravenously or subcutaneously.

DRUG

Carfilzomib

Carfilzomib will be administered intravenously.

DRUG

Dexamethasone

Dexamethasone will be administered either orally or intravenously.

DRUG

Lenalidomide

Lenalidomide will be administered orally.

DRUG

Pomalidomide

Pomalidomide will be administered orally.

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

Locations (88)

University of Miami Sylvester Cancer Center

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Barnes-jewish Hospital

St Louis, Missouri, United States

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

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Baylor University Medical Center

Dallas, Texas, United States

ZAS Cadix

Antwerp, Belgium

Liga Norte Riograndense Contra O Cancer

Natal, Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, Brazil

Ministerio da Saude Instituto Nacional do Cancer

Rio de Janeiro, Brazil

COI Clinicas Oncologicas Integradas

Rio de Janeiro, Brazil

Real e Benemerita Associacao Portuguesa de Beneficencia

São Paulo, Brazil

Clinica Medica Sao Germano S/S LTDA

São Paulo, Brazil

Peking Union Medical College Hospital

Beijing, China

Beijing Chaoyang Hospital

Beijing, China

Peking University First Hospital

Beijing, China

Peking University People's Hospital

Beijing, China

The First Bethune Hospital of Jilin University

Changchun, China

West China Hospital Si Chuan University

Chengdu, China

Fujian Medical University

Fuzhou, China

Guangdong General Hospital

Guangzhou, China

Nanfang Hospital

Guangzhou, China

First Affiliated Hospital Medical School of Zhejiang University

Hangzhou, China

First affiliated Hospital of Zhejiang University

Hangzhou, China

Shanghai Changzheng Hospital

Shanghai, China

Ruijin Hospital Shanghai Jiao Tong University

Shanghai, China

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

The First Affiliated Hospital of Soochow University

Suzhou, China

Tianjin cancer hospital

Tianjin, China

Institute of Hematology and Blood Diseases Hospital

Tianjin, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Henan Cancer Hospital

Zhengzhou, China

Fakultni nemocnice Brno

Brno, Czechia

Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni (Main)

Pilsen, Czechia

Všeobecná fakultní nemocnice v

Prague, Czechia

Aarhus University Hospital

Aarhus N, Denmark

Centre Hospitalier Universitaire (CHU) de Caen

Caen, France

CHU Nantes

Nantes, France

Hopital Saint Louis

Paris, France

Hopital Haut Leveque

Pessac, France

Klinikum Chemnitz gGmbH

Chemnitz, Germany

Asklepios Klinik Altona

Hamburg, Germany

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

Tübingen, Germany

Alexandra General Hospital of Athens

Athens Attica, Greece

Universita Degli Studi di Roma Tor Vergata

Roma, Italy

Sapienza University of Rome

Roma, Italy

Wojewodzki Szpital Specjalistyczny w Legnicy

Legnica, Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland

S.P. Botkin Moscow City Clinical Hospital

Moscow, Russia

Nizhniy Novgorod Region Clinical Hospital

Nizhny Novgorod, Russia

Republican Hospital named by V.A.Baranova

Petrozavodsk, Russia

Ryazan Regional Clinical Hospital

Ryazan, Russia

Clinical Research Institute of Hematology and Transfusiology

Saint Petersburg, Russia

City Hospital No.15

Saint Petersburg, Russia

Saratov State Medical University

Saratov, Russia

Oncology Dispensary of Komi Republic

Syktyvkar, Russia

Pusan National University Hospital

Busan, South Korea

National Cancer Center

Goyang-si, South Korea

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

Seoul National University Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, South Korea

Hosp. Univ. Fundacion Alcorcon

Alcorcón, Spain

Hosp. Univ. Germans Trias I Pujol

Badalona, Spain

Hosp. Del Mar

Barcelona, Spain

Hosp Clinic de Barcelona

Barcelona, Spain

Inst. Cat. Doncologia-H Duran I Reynals

L'Hospitalet de Llobregat, Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, Spain

Clinica Univ. de Navarra

Madrid, Spain

Hosp. Univ. Ramon Y Cajal

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Centro Integral Oncológico Clara Campal

Madrid, Spain

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

Murcia, Spain

Clinica Univ. de Navarra

Pamplona, Spain

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, Spain

Hosp Clinico Univ de Salamanca

Salamanca, Spain

Hosp. Univ. de Canarias

San Cristóbal de La Laguna, Spain

Hosp. Mutua Terrassa

Terrassa, Spain

Hosp. Univ. Dr. Peset

Valencia, Spain

Ege Universitesi Tip Fakultesi

Izmir, Turkey (Türkiye)

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

Cherkasy, Ukraine

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

Dnipro, Ukraine

MNE Regional Oncology Center

Kharkiv, Ukraine

Vinnytsya Regional Clinical Hospital named after M.I.Pirogov

Vinnitsa, Ukraine

St James University Hospital

Leeds, United Kingdom

Royal Marsden Hospital

Surrey, United Kingdom

Clinical Research Directory

A Study of Daratumumab

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (88)