A Study of Daratumumab
Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Jun 24, 2022
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a treatment called daratumumab for patients with multiple myeloma, a type of blood cancer, or smoldering multiple myeloma, which is a less aggressive form of the disease. The goal of the study is to continue providing access to daratumumab for patients who have already benefited from it in earlier research studies. This means that if you are currently receiving daratumumab as part of another study and have not had significant issues with the treatment, you may be eligible to participate in this trial and keep receiving the medication.
To be eligible, participants must be actively receiving daratumumab and have shown benefits from it in their previous studies. They also need to agree to certain safety measures, such as pregnancy tests for women and restrictions for men regarding sperm donation. Throughout the trial, researchers will keep track of any long-term safety information related to the treatment. If you decide to join, you can expect to continue receiving your treatment while contributing to important research that may help others in the future.
Gender
ALL
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
About Janssen Research & Development, Llc
Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing innovative therapies in multiple therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. With a strong commitment to scientific excellence and patient-centered research, Janssen leverages cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. The company is focused on addressing unmet medical needs through rigorous clinical trials and a robust pipeline, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Pessac, , France
Ann Arbor, Michigan, United States
Dallas, Texas, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Paris, , France
Tianjin, , China
Paris, , France
Antwerpen, , Belgium
Pessac, , France
Beijing, , China
Chemnitz, , Germany
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Leeds, , United Kingdom
Hamburg, , Germany
Murcia, , Spain
Salamanca, , Spain
Shanghai, , China
Beijing, , China
Saratov, , Russian Federation
Goyang Si, , Korea, Republic Of
Guangzhou, , China
Saint Louis, Missouri, United States
Madrid, , Spain
Surrey, , United Kingdom
Seongnam, , Korea, Republic Of
Shanghai, , China
Zhengzhou, , China
Seoul, , Korea, Republic Of
Shanghai, , China
Saint Louis, Missouri, United States
Busan, , Korea, Republic Of
Fuzhou, , China
Moscow, , Russian Federation
Petrozavodsk, , Russian Federation
Syktyvkar, , Russian Federation
Madrid, , Spain
Cherkasy, , Ukraine
Dnepropetrovsk, , Ukraine
Vinnitsa, , Ukraine
Beijing, , China
Legnica, , Poland
Izmir, , Turkey
Madrid, , Spain
Madrid, , Spain
Nizhny Novgorod, , Russian Federation
Badalona, , Spain
Barcelona, , Spain
Madrid, , Spain
Changchun, , China
Pamplona, , Spain
Guangzhou, , China
Valencia, , Spain
Seoul, , Korea, Republic Of
Hangzhou, , China
Wenzhou, , China
Tübingen, , Germany
Chengdu, , China
Hangzhou, , China
Athens Attica, , Greece
St Petersburg, , Russian Federation
La Laguna, , Spain
Tours Cedex 9, , France
Ryazan, , Russian Federation
Madrid, , Spain
Caen, , France
New York, New York, United States
Aarhus N, , Denmark
Roma, , Italy
Hospitalet De Llobregat, Barcelona, , Spain
Nantes Cedex 1, , France
Hwasun, , Korea, Republic Of
Poznan, , Poland
Barcelona, , Spain
Saint Petersburg, , Russian Federation
Kharkov, , Ukraine
Goyang Si, , Korea, Republic Of
Thessaloniki, , Greece
Beijing, , China
Suzhou, , China
Chengdu, , China
Hangzhou, , China
Tianjin, , China
Shanghai, , China
Barcelona, , Spain
Salamanca, , Spain
Roma, , Italy
Hospitalet De Llobregat, , Spain
Patients applied
Trial Officials
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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