Daratumumab: Daratumumab will be administered either intravenously or subcutaneously.
Carfilzomib: Carfilzomib will be administered intravenously.
Dexamethasone: Dexamethasone will be administered either orally or intravenously.
Lenalidomide: Lenalidomide will be administered orally.
Pomalidomide: Pomalidomide will be administered orally.
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.
Eligibility
Sex
ALL
Min age
—
Max age
—
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, 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
Primary outcome measure(s)
Number of Participants with Serious Adverse Events (SAEs) — 3 years 7 months 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.
Number of Participants with AEs of Special Interest (AESI) — 3 years 7 months Number of participants with AESI, that is, reactivation of HBV infection, will be reported.
Number of Participants with Pregnancies or Partner Pregnancies — 3 years 7 months Number of participants with pregnancies or partner pregnancies will be reported using the appropriate pregnancy notification form.
Number of Participants with Abnormal Pregnancies as SAE — 3 years 7 months Number of Participants with Abnormal Pregnancies as SAE will be reported.
Trial sites (92)
Facility
City
Region
Status
University of Miami Sylvester Cancer Center
Miami
Florida
Emory University
Atlanta
Georgia
University of Michigan Comprehensive Cancer Center
Ann Arbor
Michigan
Barnes-jewish Hospital
St Louis
Missouri
Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
New York
New York
Memorial Sloan Kettering Cancer Center
New York
New York
Baylor University Medical Center
Dallas
Texas
ZAS Cadix
Antwerp
Belgium
Hospital das Clinicas da Universidade Estadual de Campinas UNICAMP
Campinas
Brazil
Liga Norte Riograndense Contra O Cancer
Natal
Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre
Brazil
Ministerio da Saude Instituto Nacional do Cancer
Rio de Janeiro
Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro
Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo
Brazil
Clinica Medica Sao Germano LTDA
São Paulo
Brazil
Peking Union Medical College Hospital
Beijing
China
Beijing Chaoyang Hospital
Beijing
China
Peking University First Hospital
Beijing
China
Peking University People's Hospital
Beijing
China
The First Bethune Hospital of Jilin University
Changchun
China
West China Hospital Si Chuan University
Chengdu
China
Fujian Medical University
Fuzhou
China
Guangdong General Hospital
Guangzhou
China
Nanfang Hospital
Guangzhou
China
First Affiliated Hospital Medical School of Zhejiang University
Hangzhou
China
First affiliated Hospital of Zhejiang University
Hangzhou
China
Shanghai Changzheng Hospital
Shanghai
China
Ruijin Hospital Shanghai Jiao Tong University
Shanghai
China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
China
The First Affiliated Hospital of Soochow University
Suzhou
China
Tianjin cancer hospital
Tianjin
China
Institute of Hematology and Blood Diseases Hospital
Tianjin
China
The First Affiliated Hospital of Wenzhou Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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