A Study of Daratumumab
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT05438043
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Daratumumab 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. Daratumumab Carfilzomib 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. Daratumumab Dexamethasone 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. Daratumumab Lenalidomide 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. Daratumumab Pomalidomide 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.
- Primary Outcome Measures
Name Time Method Number of Participants with Serious Adverse Events (SAEs) 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.
Number of Participants with AEs of Special Interest (AESI) 3 years 7 months Number of participants with AESI, that is, reactivation of HBV infection, will be reported.
Number of Participants with Pregnancies or Partner Pregnancies 3 years 7 months Number of participants with pregnancies or partner pregnancies will be reported using the appropriate pregnancy notification form.
Number of Participants with Abnormal Pregnancies as SAE 3 years 7 months Number of Participants with Abnormal Pregnancies as SAE will be reported.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (72)
University of Miami Sylvester Cancer Center
🇺🇸Miami, Florida, United States
Barnes-jewish Hospital
🇺🇸Saint Louis, Missouri, United States
ZNA Stuivenberg
🇧🇪Antwerpen, Belgium
Alexandra General Hospital of Athens
🇬🇷Athens Attica, Greece
Nizhniy Novgorod Region Clinical Hospital
🇷🇺Nizhny Novgorod, Russian Federation
Clinical Research Institute of Hematology and Transfusiology
🇷🇺St-Petersburg, Russian Federation
City Hospital No.15
🇷🇺Saint-Petersburg, Russian Federation
Oncology Dispensary of Komi Republic
🇷🇺Syktyvkar, Russian Federation
Wojewodzki Szpital Specjalistyczny w Legnicy
🇵🇱Legnica, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
🇵🇱Poznan, Poland
Republican Hospital named by V.A.Baranova
🇷🇺Petrozavodsk, Russian Federation
Ryazan Regional Clinical Hospital
🇷🇺Ryazan, Russian Federation
Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
🇺🇦Vinnitsa, Ukraine
Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center
🇺🇦Dnepropetrovsk, Ukraine
Saratov State Medical University
🇷🇺Saratov, Russian Federation
S.P. Botkin Moscow City Clinical Hospital
🇷🇺Moscow, Russian Federation
Universita Degli Studi di Roma Tor Vergata
🇮🇹Roma, Italy
Sapienza University of Rome
🇮🇹Roma, Italy
National Cancer Center
🇰🇷Goyang-si, Korea, Republic of
Beijing Chaoyang Hospital
🇨🇳Beijing, China
Guangdong General Hospital
🇨🇳Guangzhou, China
Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
🇺🇦Cherkasy, Ukraine
Kharkov Regional Clinical Oncology Center, Dept. of Hematology
🇺🇦Kharkov, Ukraine
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Peking University First Hospital
🇨🇳Beijing, China
Peking University People s Hospital
🇨🇳Beijing, China
West China Hospital Si Chuan University
🇨🇳Chengdu, China
The First Bethune Hospital of Jilin University
🇨🇳Changchun, China
Fujian Medical University
🇨🇳Fuzhou, China
First Affiliated Hospital Medical School of Zhejiang University
🇨🇳Hangzhou, China
Nanfang Hospital
🇨🇳Guangzhou, 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
First Affiliated Hospital SooChow University
🇨🇳Suzhou, China
Tianjin cancer hospital
🇨🇳Tianjin, China
Institute of Hematology and Blood Diseases Hospital
🇨🇳Tianjin, China
Aarhus University Hospital
🇩🇰Aarhus N, Denmark
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, China
Centre Hospitalier Universitaire (CHU) de Caen
🇫🇷Caen, France
Henan Cancer Hospital
🇨🇳Zhengzhou, China
CHU Nantes
🇫🇷Nantes Cedex 1, France
Hopital Haut Leveque
🇫🇷Pessac, France
Hopital Saint Louis
🇫🇷Paris, France
Klinikum Chemnitz gGmbH
🇩🇪Chemnitz, Germany
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
🇩🇪Tübingen, Germany
Asklepios Klinik Altona
🇩🇪Hamburg, Germany
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul St Marys Hospital
🇰🇷Seoul, Korea, Republic of
Inst. Cat. Doncologia-H Duran I Reynals
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Hosp. Univ. Germans Trias I Pujol
🇪🇸Badalona, Spain
Clinica Univ. de Navarra
🇪🇸Pamplona, Spain
Hosp. Univ. Ramon Y Cajal
🇪🇸Madrid, Spain
Hosp Clinic de Barcelona
🇪🇸Barcelona, Spain
Hosp. Gral. Univ. Gregorio Maranon
🇪🇸Madrid, Spain
Hosp. Univ. de Canarias
🇪🇸La Laguna, Spain
Hosp. Univ. 12 de Octubre
🇪🇸Madrid, Spain
Centro Integral Oncológico Clara Campal
🇪🇸Madrid, Spain
Hosp Clinico Univ de Salamanca
🇪🇸Salamanca, Spain
Hosp. Univ. Dr. Peset
🇪🇸Valencia, Spain
Hosp. Gral. Univ. J.M. Morales Meseguer
🇪🇸Murcia, Spain
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, 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
Peking Union Medical College Hospital
🇨🇳Beijing, China