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

Status: Recruiting
Location: See all (75) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
University of Miami Sylvester Cancer Center
ACTIVE_NOT_RECRUITING
Miami
Georgia
Emory University
ACTIVE_NOT_RECRUITING
Atlanta
Michigan
University of Michigan Comprehensive Cancer Center
ACTIVE_NOT_RECRUITING
Ann Arbor
Missouri
Barnes-jewish Hospital
ACTIVE_NOT_RECRUITING
Saint Louis
New York
Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
ACTIVE_NOT_RECRUITING
New York
Memorial Sloan Kettering Cancer Center
ACTIVE_NOT_RECRUITING
New York
Texas
Baylor University Medical Center
ACTIVE_NOT_RECRUITING
Dallas
Other Locations
Belgium
ZNA Stuivenberg
ACTIVE_NOT_RECRUITING
Antwerpen
China
Beijing Chaoyang Hospital
ACTIVE_NOT_RECRUITING
Beijing
Peking Union Medical College Hospital
ACTIVE_NOT_RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Peking University People s Hospital
ACTIVE_NOT_RECRUITING
Beijing
The First Bethune Hospital of Jilin University
ACTIVE_NOT_RECRUITING
Changchun
West China Hospital Si Chuan University
ACTIVE_NOT_RECRUITING
Chengdu
Fujian Medical University
ACTIVE_NOT_RECRUITING
Fuzhou
Guangdong General Hospital
ACTIVE_NOT_RECRUITING
Guangzhou
Nanfang Hospital
ACTIVE_NOT_RECRUITING
Guangzhou
First Affiliated Hospital Medical School of Zhejiang University
ACTIVE_NOT_RECRUITING
Hangzhou
First affiliated Hospital of Zhejiang University
ACTIVE_NOT_RECRUITING
Hangzhou
Renji Hospital, Shanghai Jiaotong University School of Medicine
ACTIVE_NOT_RECRUITING
Shanghai
Ruijin Hospital Shanghai Jiao Tong University
RECRUITING
Shanghai
Shanghai Changzheng Hospital
RECRUITING
Shanghai
First Affiliated Hospital SooChow University
RECRUITING
Suzhou
Institute of Hematology and Blood Diseases Hospital
ACTIVE_NOT_RECRUITING
Tianjin
Tianjin cancer hospital
ACTIVE_NOT_RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
ACTIVE_NOT_RECRUITING
Wenzhou
Henan Cancer Hospital
COMPLETED
Zhengzhou
Denmark
Aarhus University Hospital
ACTIVE_NOT_RECRUITING
Aarhus N
France
Centre Hospitalier Universitaire (CHU) de Caen
COMPLETED
Caen
CHU Nantes
ACTIVE_NOT_RECRUITING
Nantes Cedex 1
Hopital Saint Louis
ACTIVE_NOT_RECRUITING
Paris
Hopital Haut Leveque
COMPLETED
Pessac
Germany
Klinikum Chemnitz gGmbH
ACTIVE_NOT_RECRUITING
Chemnitz
Asklepios Klinik Altona
ACTIVE_NOT_RECRUITING
Hamburg
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
COMPLETED
Tübingen
Greece
Alexandra General Hospital of Athens
ACTIVE_NOT_RECRUITING
Athens Attica
Anticancer Hospital of Thessaloniki Theageneio
COMPLETED
Thessaloniki
Italy
Sapienza University of Rome
ACTIVE_NOT_RECRUITING
Roma
Universita Degli Studi di Roma Tor Vergata
ACTIVE_NOT_RECRUITING
Roma
Poland
Wojewodzki Szpital Specjalistyczny w Legnicy
ACTIVE_NOT_RECRUITING
Legnica
Uniwersytecki Szpital Kliniczny w Poznaniu
ACTIVE_NOT_RECRUITING
Poznan
Republic of Korea
Pusan National University Hospital
ACTIVE_NOT_RECRUITING
Busan
National Cancer Center
ACTIVE_NOT_RECRUITING
Goyang Si
Chonnam National University Hwasun Hospital
ACTIVE_NOT_RECRUITING
Hwasun
Seoul National University Bundang Hospital
ACTIVE_NOT_RECRUITING
Seongnam
Samsung Medical Center
ACTIVE_NOT_RECRUITING
Seoul
Seoul National University Hospital
ACTIVE_NOT_RECRUITING
Seoul
The Catholic University of Korea Seoul St Marys Hospital
ACTIVE_NOT_RECRUITING
Seoul
Russian Federation
S.P. Botkin Moscow City Clinical Hospital
RECRUITING
Moscow
Nizhniy Novgorod Region Clinical Hospital
RECRUITING
Nizhny Novgorod
Republican Hospital named by V.A.Baranova
RECRUITING
Petrozavodsk
Ryazan Regional Clinical Hospital
RECRUITING
Ryazan
City Hospital No.15
RECRUITING
Saint-petersburg
Saratov State Medical University
RECRUITING
Saratov
Clinical Research Institute of Hematology and Transfusiology
RECRUITING
St-petersburg
Oncology Dispensary of Komi Republic
RECRUITING
Syktyvkar
Spain
Hosp. Univ. Germans Trias I Pujol
ACTIVE_NOT_RECRUITING
Badalona
Hosp Clinic de Barcelona
ACTIVE_NOT_RECRUITING
Barcelona
Inst. Cat. Doncologia-H Duran I Reynals
ACTIVE_NOT_RECRUITING
Hospitalet De Llobregat
Hosp. Univ. de Canarias
ACTIVE_NOT_RECRUITING
La Laguna
Centro Integral Oncológico Clara Campal
ACTIVE_NOT_RECRUITING
Madrid
Clinica Univ. de Navarra
ACTIVE_NOT_RECRUITING
Madrid
Hosp. Gral. Univ. Gregorio Maranon
ACTIVE_NOT_RECRUITING
Madrid
Hosp. Univ. 12 de Octubre
ACTIVE_NOT_RECRUITING
Madrid
Hosp. Univ. Ramon Y Cajal
ACTIVE_NOT_RECRUITING
Madrid
Hosp. Gral. Univ. J.M. Morales Meseguer
COMPLETED
Murcia
Clinica Univ. de Navarra
ACTIVE_NOT_RECRUITING
Pamplona
Hosp Clinico Univ de Salamanca
ACTIVE_NOT_RECRUITING
Salamanca
Hosp. Univ. Dr. Peset
ACTIVE_NOT_RECRUITING
Valencia
Ukraine
Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
ACTIVE_NOT_RECRUITING
Cherkasy
Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center
ACTIVE_NOT_RECRUITING
Dnepropetrovsk
Kharkov Regional Clinical Oncology Center, Dept. of Hematology
ACTIVE_NOT_RECRUITING
Kharkov
Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
ACTIVE_NOT_RECRUITING
Vinnitsa
United Kingdom
St James University Hospital
ACTIVE_NOT_RECRUITING
Leeds
Royal Marsden Hospital
ACTIVE_NOT_RECRUITING
Surrey
Contact Information
Primary
Study Contact
Participate-In-This-Study@its.jnj.com
844-434-4210
Time Frame
Start Date: 2022-12-15
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 500
Treatments
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.
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov