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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
213
Daratumumab will be administered either intravenously or subcutaneously.
Carfilzomib will be administered intravenously.
Dexamethasone will be administered either orally or intravenously.
Number of Participants with Serious Adverse Events (SAEs)
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.
Time frame: 3 years 7 months
Number of Participants with AEs of Special Interest (AESI)
Number of participants with AESI, that is, reactivation of HBV infection, will be reported.
Time frame: 3 years 7 months
Number of Participants with Pregnancies or Partner Pregnancies
Number of participants with pregnancies or partner pregnancies will be reported using the appropriate pregnancy notification form.
Time frame: 3 years 7 months
Number of Participants with Abnormal Pregnancies as SAE
Number of Participants with Abnormal Pregnancies as SAE will be reported.
Time frame: 3 years 7 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Lenalidomide will be administered orally.
Pomalidomide will be administered orally.
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