Clinical trial NCT05438043: A Study of Daratumumab
Official title: A Phase 3b, Multicenter, Open-label, Daratumumab Long-term Extension Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Multiple Myeloma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-06-29
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: 3 years 7 months
measure: Number of Participants with AEs of Special Interest (AESI)
timeFrame: 3 years 7 months
measure: Number of Participants with Pregnancies or Partner Pregnancies
timeFrame: 3 years 7 months
measure: Number of Participants with Abnormal Pregnancies as SAE
timeFrame: 3 years 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Sylvester Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Saint Louis
country: United States
facility: Barnes-jewish Hospital
state: Missouri
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Antwerpen
country: Belgium
facility: ZNA Stuivenberg
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University People s Hospital
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
city: Chengdu
country: China
facility: West China Hospital Si Chuan University
city: Fuzhou
country: China
facility: Fujian Medical University
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Guangzhou
country: China
facility: Nanfang Hospital
city: Hangzhou
country: China
facility: First Affiliated Hospital Medical School of Zhejiang University
city: Hangzhou
country: China
facility: First affiliated Hospital of Zhejiang University
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University
city: ShangHai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
city: Suzhou
country: China
facility: First Affiliated Hospital SooChow University
city: Tianjin
country: China
facility: Tianjin cancer hospital
city: Tianjin
country: China
facility: Institute of Hematology and Blood Diseases Hospital
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: Caen
country: France
facility: Centre Hospitalier Universitaire (CHU) de Caen
city: Nantes Cedex 1
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Hopital Saint Louis
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Tübingen
country: Germany
facility: Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
city: Athens Attica
country: Greece
facility: Alexandra General Hospital of Athens
city: Thessaloniki
country: Greece
facility: Anticancer Hospital of Thessaloniki Theageneio
city: Roma
country: Italy
facility: Universita Degli Studi di Roma Tor Vergata
city: Roma
country: Italy
facility: Sapienza University of Rome
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Goyang si
country: Korea, Republic of
facility: National Cancer Center
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Marys Hospital
city: Legnica
country: Poland
facility: Wojewodzki Szpital Specjalistyczny w Legnicy
city: Poznan
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu
city: Moscow
country: Russian Federation
facility: S.P. Botkin Moscow City Clinical Hospital
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhniy Novgorod Region Clinical Hospital
city: Petrozavodsk
country: Russian Federation
facility: Republican Hospital named by V.A.Baranova
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Hospital
city: Saint-Petersburg
country: Russian Federation
facility: City Hospital No.15
city: Saratov
country: Russian Federation
facility: Saratov State Medical University
city: St-Petersburg
country: Russian Federation
facility: Clinical Research Institute of Hematology and Transfusiology
city: Syktyvkar
country: Russian Federation
facility: Oncology Dispensary of Komi Republic
city: Badalona
country: Spain
facility: Hosp. Univ. Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Inst. Cat. Doncologia-H Duran I Reynals
city: La Laguna
country: Spain
facility: Hosp. Univ. de Canarias
city: Madrid
country: Spain
facility: Hosp. Gral. Univ. Gregorio Maranon
city: Madrid
country: Spain
facility: Clinica Univ. de Navarra
city: Madrid
country: Spain
facility: Hosp. Univ. Ramon Y Cajal
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Madrid
country: Spain
facility: Centro Integral Oncológico Clara Campal
city: Murcia
country: Spain
facility: Hosp. Gral. Univ. J.M. Morales Meseguer
city: Pamplona
country: Spain
facility: Clinica Univ. de Navarra
city: Salamanca
country: Spain
facility: Hosp Clinico Univ de Salamanca
city: Valencia
country: Spain
facility: Hosp. Univ. Dr. Peset
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi
city: Cherkasy
country: Ukraine
facility: Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
city: Dnepropetrovsk
country: Ukraine
facility: Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center
city: Kharkov
country: Ukraine
facility: Kharkov Regional Clinical Oncology Center, Dept. of Hematology
city: Vinnitsa
country: Ukraine
facility: Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: Surrey
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: