Multiple Myeloma Clinical Trial

A Study of Daratumumab

Summary

The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma who are actively receiving daratumumab in a Janssen Research and Development (R&D)-sponsored daratumumab study which has reached clinical cutoff for final analysis and who continue to benefit from study treatment. Certain long-term safety data will continue to be collected from study participants.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

500

Study ID:

NCT05438043

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 42 Locations for this study

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Washington University in St. Louis
Saint Louis Missouri, 63130, United States
Baylor University Medical Center
Dallas Texas, 75246, United States
ZNA Stuivenberg
Antwerpen , 2060, Belgium
First affiliated Hospital of Zhejiang University
Hangzhou , 31002, China
First Affiliated Hospital, Medical School of Zhejiang University
Hangzhou , 31002, China
Shanghai First People's Hospital
Shanghai , 20008, China
Aarhus University Hospital
Aarhus N , DK-82, Denmark
Centre Hospitalier Universitaire (CHU) de Caen
Caen , 14033, France
CHU Nantes
Nantes Cedex 1 , 44000, France
Hopital Saint Louis
Paris , 75010, France
Hôpital Haut-Lévêque
Pessac , 33604, France
Klinikum Chemnitz gGmbH
Chemnitz , 09113, Germany
Asklepios Klinik Altona
Hamburg , 22763, Germany
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
Tübingen , 72076, Germany
Alexandra General Hospital of Athens
Athens Attica , 115 2, Greece
Pusan National University Hospital
Busan , 49241, Korea, Republic of
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun , 519-8, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam , 13620, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of
S.P. Botkin Moscow City Clinical Hospital
Moscow , 12528, Russian Federation
Nizhniy Novgorod Region Clinical Hospital
Nizhny Novgorod , 60312, Russian Federation
Republican Hospital named by V.A.Baranova
Petrozavodsk , 18501, Russian Federation
Ryazan Regional Clinical Hospital
Ryazan , 39000, Russian Federation
City Hospital No.15
Saint-Petersburg , 19820, Russian Federation
Saratov State Medical University
Saratov , 41001, Russian Federation
Clinical Research Institute of Hematology and Transfusiology
St-Petersburg , 19102, Russian Federation
Oncology Dispensary of Komi Republic
Syktyvkar , 16790, Russian Federation
Hosp. Univ. Germans Trias I Pujol
Badalona , 08916, Spain
Hosp. Clinic de Barcelona
Barcelona , 08036, Spain
Clinica Univ. de Navarra
Madrid , 28027, Spain
Hosp. Univ. Ramon Y Cajal
Madrid , 28034, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Hosp. Gral. Univ. J.M. Morales Meseguer
Murcia , 30008, Spain
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain
Hosp. Univ. Dr. Peset
Valencia , 46017, Spain
Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
Cherkasy , 18009, Ukraine
Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center
Dnepropetrovsk , 49102, Ukraine
Kharkov Regional Clinical Oncology Center, Dept. of Hematology
Kharkov , 61070, Ukraine
Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
Vinnitsa , 21018, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

500

Study ID:

NCT05438043

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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