Multiple Myeloma Clinical Trial
A Study of Daratumumab
The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma who are actively receiving daratumumab in a Janssen Research and Development (R&D)-sponsored daratumumab study which has reached clinical cutoff for final analysis and who continue to benefit from study treatment. Certain long-term safety data will continue to be collected from study participants.
Daratumumab activity has been observed in multiple myeloma studies of daratumumab intravenous (IV) and subcutaneous (SC) monotherapy and combination therapy. Daratumumab (JNJ-54767414) is a first-in-class, human Immunoglobulin G1 kappa (IgG1 kappa) monoclonal antibody (mAb) that specifically binds to the cell surface molecule cluster of differentiation 38 (CD38). Daratumumab binds CD38 expressing cells with high affinity in a variety of hematological malignancies, including myeloma, lymphomas, and leukemias, as well as other cell types and tissues with various expression levels, including aberrant plasma cells in systemic light chain amyloid light chain (AL) amyloidosis. This study will provide ongoing access to study treatments for participants with multiple myeloma who are actively receiving daratumumab in a Janssen R&D-sponsored daratumumab study. Participants will continue with the current study treatment dosing regimen established in the parent study. The study will consist of screening phase (up to 6 weeks), treatment phase (28-day cycle) and end of treatment visit 30 days after last dose of study treatment. Safety should be monitored and evaluated according to local institutional standard of care. Safety evaluations and adverse events (AEs) should be documented in the source medical record. Collection of serious adverse events (SAEs), pregnancies, and reports of HBV reactivation will continue until the End of Treatment (EOT) Visit 30 days after the last dose of study treatment or until the start of subsequent anti-cancer therapy, if earlier. The total duration of the study is 3 years 7 months.
Participants must be actively receiving daratumumab (either as monotherapy or in combination with other therapy) in a Janssen research and development (R&D)-sponsored daratumumab study for participants with 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 daratumumab within the previous 3 months
Investigator's assessment that the benefit of continued daratumumab therapy 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
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There are 21 Locations for this study
Dallas Texas, 75246, United States
Nantes Cedex 1 , 44000, France
Paris , 75010, France
Pessac , 33604, France
Tours Cedex 9 , 37044, France
Chemnitz , 09113, Germany
Hamburg , 22763, Germany
Tübingen , 72076, Germany
Busan , 49241, Korea, Republic of
Hwasun , 519-8, Korea, Republic of
Seongnam , 13620, Korea, Republic of
Seoul , 06351, Korea, Republic of
Badalona , 08916, Spain
Barcelona , 08036, Spain
Madrid , 28007, Spain
Madrid , 28027, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Pamplona , 31008, Spain
Salamanca , 37007, Spain
Valencia , 46017, Spain
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