A Study of Daratumumab

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Jun 24, 2022

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