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RECRUITINGPhase 3INTERVENTIONAL

A Study of Daratumumab

A Phase 3b, Multicenter, Open-label, Daratumumab Long-term Extension Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Daratumumab

Daratumumab will be administered either intravenously or subcutaneously.

DRUG

Carfilzomib

Carfilzomib will be administered intravenously.

DRUG

Dexamethasone

Dexamethasone will be administered either orally or intravenously.

DRUG

Lenalidomide

Lenalidomide will be administered orally.

DRUG

Pomalidomide

Pomalidomide will be administered orally.

Locations (20)

University of Miami Sylvester Cancer Center
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barnes-jewish Hospital
St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Baylor University Medical Center
Dallas, Texas, United States
ZAS Cadix
Antwerp, Belgium
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
COI Clinicas Oncologicas Integradas
Rio de Janeiro, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, Brazil
Clinica Medica Sao Germano S/S 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