A Phase 3b, Multicenter, Open-label, Daratumumab Long-term Extension Study
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.
Arms & interventions
- DrugDaratumumab
Daratumumab will be administered either intravenously or subcutaneously.
- DrugCarfilzomib
Carfilzomib will be administered intravenously.
- DrugDexamethasone
Dexamethasone will be administered either orally or intravenously.
- DrugLenalidomide
Lenalidomide will be administered orally.
- DrugPomalidomide
Pomalidomide will be administered orally.
Outcome measures
Primary
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
Eligibility criteria
Study locations (7)
University of Miami Sylvester Cancer Center
Miami, Florida, 33136
Emory University
Atlanta, Georgia, 30322
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Barnes-jewish Hospital
St Louis, Missouri, 63108
Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Baylor University Medical Center
Dallas, Texas, 75246