A Phase 3b, Multicenter, Open-label, Daratumumab Long-term Extension Study
Janssen Research & Development, LLC
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.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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…
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.
Locations (91)
- University of Miami Sylvester Cancer CenterMiami, Florida
- Emory UniversityAtlanta, Georgia
- University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan
- Barnes-jewish HospitalSt Louis, Missouri
- Icahn School of Medicine at Mount Sinai - The Derald H. RuttenbergNew York, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York