Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT05438043

Reclutamento in corso

A Study of Daratumumab

Interventistico

Fase 3

University of Michigan Comprehensive Cancer Center

Sponsor: Janssen

Ultimo Aggiornamento: 16 marzo 2026
Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.

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.

Categoria di Trattamento

Chemioterapia, Anticorpi Monoclonali, Altri Farmaci

Mutazioni richieste

Nessuno

Studio Iniziato

15 dicembre 2022

Ultimo Aggiornamento dello Sponsor

16 marzo 2026

Completamento Stimato

31 gennaio 2029

Contatto dello studio

Nome:Study Contact

Email:Participate-In-This-Study1@its.jnj.com

Telefono:844-434-4210

Idoneità

Criteri di Inclusione

* 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

Criteri di Esclusione

* 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

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Dettagli del Disegno

AllocazioneN/A

Modello di InterventoSingle Group Assignment

MascheramentoNone (Open Label)

Numero da Arruolare500

Bracci e Interventi

Bracci

Interventi

Tipo: Experimental

Descrizione: Participants will receive a single dose of daratumumab 16 milligrams per kilograms (mg/kg) intravenous (IV) or 1800 mg subcutaneous (SC) infusion on Cycle 1 Day 1 (28-day cycle), as monotherapy or in combination with standards of care treatment (that is, pomalidomide and dexamethasone, lenalidomide and dexamethasone, carfilzomib and dexamethasone) or standards of care treatment alone, depending on the treatment received in the parent study. Participants who received daratumumab IV during the parent study, will have an option to switch to daratumumab SC on Day 1 of any cycle during this long-term extension study.

Interventi:

Lenalidomide
Daratumumab
Carfilzomib
Dexamethasone
Pomalidomide

Misure di Esito

Misure di Esito Primarie

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 Pregnancies3 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 SAE3 years 7 months

Number of Participants with Abnormal Pregnancies as SAE will be reported.

Misure di Esito Secondarie

Nessuno

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Siti dello Studio

Questo studio ha 3 siti

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, US

In fase di reclutamento

São Paulo, 04537-081 BR

Clinica Medica Sao Germano S/S LTDA

In fase di reclutamento

São Paulo, 01323 010 BR

Real e Benemerita Associacao Portuguesa de Beneficencia

In fase di reclutamento

Porto Alegre, 90610 000 BR

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

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