JOURNAL ONKOLOGIE – STUDIE

A Study of Daratumumab

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05438043

Studienbeginn:
Dezember 2022

Letztes Update:
24.04.2024

Wirkstoff:
Daratumumab, Carfilzomib, Dexamethasone, Lenalidomide, Pomalidomide

Indikation (Clinical Trials):
Multiple Myeloma

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 3

Sponsor:
Janssen Research & Development, LLC

Collaborator:
-

Studienleiter

Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC

Kontakt

Study Contact
Kontakt:
Phone: 844-434-4210
E-Mail: Participate-In-This-Study@its.jnj.com» Kontaktdaten anzeigen

Studienlocations
(3 von 43)

Klinikum Chemnitz gGmbH
09113 Chemnitz
(Sachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps

Asklepios Klinik Altona
22763 Hamburg
(Hamburg)
GermanyAktiv, nicht rekrutierend» Google-Maps

Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
72076 Tübingen
(Baden-Württemberg)
GermanyAktiv, nicht rekrutierend» Google-Maps

Washington University in St. Louis
63130 Saint Louis
United StatesAktiv, nicht rekrutierend» Google-Maps

Baylor University Medical Center
75246 Dallas
United StatesAktiv, nicht rekrutierend» Google-Maps

ZNA Stuivenberg
2060 Antwerpen
BelgiumAktiv, nicht rekrutierend» Google-Maps

Aarhus University Hospital
DK-8200 Aarhus N
DenmarkAktiv, nicht rekrutierend» Google-Maps

Centre Hospitalier Universitaire (CHU) de Caen
14033 Caen
FranceAktiv, nicht rekrutierend» Google-Maps

CHU Nantes
44000 Nantes Cedex 1
FranceAktiv, nicht rekrutierend» Google-Maps

Hopital Saint Louis
75010 Paris
FranceAktiv, nicht rekrutierend» Google-Maps

Hôpital Haut-Lévêque
33604 Pessac
FranceAktiv, nicht rekrutierend» Google-Maps

Alexandra General Hospital of Athens
115 28 Athens Attica
GreeceAktiv, nicht rekrutierend» Google-Maps

Pusan National University Hospital
49241 Busan
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps

National Cancer Center
10408 Goyang-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps

Chonnam National University Hwasun Hospital
519-800 Hwasun
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps

Seoul National University Bundang Hospital
13620 Seongnam
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps

Seoul National University Hospital
03080 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps

Samsung Medical Center
06351 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps

The Catholic University of Korea Seoul St. Mary's Hospital
06591 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps

Wojewodzki Szpital Specjalistyczny w Legnicy
59-220 Legnica
PolandAktiv, nicht rekrutierend» Google-Maps

S.P. Botkin Moscow City Clinical Hospital
125284 Moscow
Russian FederationRekrutierend» Google-Maps

Nizhniy Novgorod Region Clinical Hospital
603126 Nizhny Novgorod
Russian FederationRekrutierend» Google-Maps

Republican Hospital named by V.A.Baranova
185019 Petrozavodsk
Russian FederationRekrutierend» Google-Maps

Ryazan Regional Clinical Hospital
390003 Ryazan
Russian FederationRekrutierend» Google-Maps

City Hospital No.15
198205 Saint-Petersburg
Russian FederationRekrutierend» Google-Maps

Saratov State Medical University
410012 Saratov
Russian FederationRekrutierend» Google-Maps

Clinical Research Institute of Hematology and Transfusiology
191024 St-Petersburg
Russian FederationRekrutierend» Google-Maps

Oncology Dispensary of Komi Republic
167904 Syktyvkar
Russian FederationRekrutierend» Google-Maps

Hosp. Univ. Germans Trias I Pujol
08916 Badalona
SpainRekrutierend» Google-Maps

Hosp. Clinic de Barcelona
08036 Barcelona
SpainAktiv, nicht rekrutierend» Google-Maps

Hosp. Gral. Univ. Gregorio Maranon
28007 Madrid
SpainRekrutierend» Google-Maps

Clinica Univ. de Navarra
28027 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps

Hosp. Univ. Ramon Y Cajal
28034 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps

Hosp. Univ. 12 de Octubre
28041 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps

Centro Integral Oncológico Clara Campal
28050 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps

Hosp. Gral. Univ. J.M. Morales Meseguer
30008 Murcia
SpainRekrutierend» Google-Maps

Clinica Univ. de Navarra
31008 Pamplona
SpainAktiv, nicht rekrutierend» Google-Maps

Hosp. Clinico Univ. de Salamanca
37007 Salamanca
SpainAktiv, nicht rekrutierend» Google-Maps

Hosp. Univ. Dr. Peset
46017 Valencia
SpainAktiv, nicht rekrutierend» Google-Maps

Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
18009 Cherkasy
UkraineAktiv, nicht rekrutierend» Google-Maps

Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center
49102 Dnepropetrovsk
UkraineAktiv, nicht rekrutierend» Google-Maps

Kharkov Regional Clinical Oncology Center, Dept. of Hematology
61070 Kharkov
UkraineAktiv, nicht rekrutierend» Google-Maps

Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
21018 Vinnitsa
UkraineAktiv, nicht rekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

Brief 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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Number of Participants with Serious Adverse Events (SAEs) (Time Frame - 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.

2. Number of Participants with AEs of Special Interest (AESI) (Time Frame - 3 years 7 months):
Number of participants with AESI, that is, reactivation of HBV infection, will be reported.

3. Number of Participants with Pregnancies or Partner Pregnancies (Time Frame - 3 years 7 months):
Number of participants with pregnancies or partner pregnancies will be reported using the appropriate pregnancy notification form.

4. Number of Participants with Abnormal Pregnancies as SAE (Time Frame - 3 years 7 months):
Number of Participants with Abnormal Pregnancies as SAE will be reported.

Geprüfte Regime

Daratumumab (JNJ-54767414):
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.

Quelle: ClinicalTrials.gov

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