A Study of Daratumumab
Last Updated   April 24, 2024 - 21:04
OVERVIEW
-
Gender
all -
Age
years -
Phase
phase 3The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. -
Sites
sites -
Status
Recruiting
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.
CONDITIONS
- Multiple Myeloma
ELIGIBILITY
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
DETAILS
LOCATIONS
Country (11) | City or Province (43) | Status |
United States | Dallas, TX Baylor University Medical Center |
ACTIVE_NOT_RECRUITING
|
United States | Saint Louis, MO Washington University in St. Louis |
ACTIVE_NOT_RECRUITING
|
Ukraine | Cherkasy Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council' |
ACTIVE_NOT_RECRUITING
|
Ukraine | Dnepropetrovsk Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center |
ACTIVE_NOT_RECRUITING
|
Ukraine | Kharkov Kharkov Regional Clinical Oncology Center, Dept. of Hematology |
ACTIVE_NOT_RECRUITING
|
Ukraine | Vinnitsa Vinnytsya Regional Clinical Hospital named after M.I.Pirogov |
ACTIVE_NOT_RECRUITING
|
Spain | Badalona, BA Hosp. Univ. Germans Trias I Pujol |
RECRUITING
|
Spain | Barcelona, BA Hosp. Clinic de Barcelona |
ACTIVE_NOT_RECRUITING
|
Spain | Madrid, MD Centro Integral Oncológico Clara Campal |
ACTIVE_NOT_RECRUITING
|
Spain | Madrid, MD Clinica Univ. de Navarra |
ACTIVE_NOT_RECRUITING
|
Spain | Madrid, MD Hosp. Gral. Univ. Gregorio Maranon |
RECRUITING
|
Spain | Madrid, MD Hosp. Univ. 12 de Octubre |
ACTIVE_NOT_RECRUITING
|
Spain | Madrid, MD Hosp. Univ. Ramon Y Cajal |
ACTIVE_NOT_RECRUITING
|
Spain | Murcia, MU Hosp. Gral. Univ. J.M. Morales Meseguer |
RECRUITING
|
Spain | Pamplona Clinica Univ. de Navarra |
ACTIVE_NOT_RECRUITING
|
Spain | Salamanca, SL Hosp. Clinico Univ. de Salamanca |
ACTIVE_NOT_RECRUITING
|
Spain | Valencia, VC Hosp. Univ. Dr. Peset |
ACTIVE_NOT_RECRUITING
|
South Korea | Busan Pusan National University Hospital |
ACTIVE_NOT_RECRUITING
|
South Korea | Goyang-si, 41 National Cancer Center |
ACTIVE_NOT_RECRUITING
|
South Korea | Hwasun, 46 Chonnam National University Hwasun Hospital |
ACTIVE_NOT_RECRUITING
|
South Korea | Seongnam, 41 Seoul National University Bundang Hospital |
ACTIVE_NOT_RECRUITING
|
South Korea | Seoul Samsung Medical Center |
ACTIVE_NOT_RECRUITING
|
South Korea | Seoul Seoul National University Hospital |
ACTIVE_NOT_RECRUITING
|
South Korea | Seoul The Catholic University of Korea Seoul St. Mary's Hospital |
ACTIVE_NOT_RECRUITING
|
Russia | Moscow S.P. Botkin Moscow City Clinical Hospital |
RECRUITING
|
Russia | Nizhny Novgorod Nizhniy Novgorod Region Clinical Hospital |
RECRUITING
|
Russia | Petrozavodsk Republican Hospital named by V.A.Baranova |
RECRUITING
|
Russia | Ryazan Ryazan Regional Clinical Hospital |
RECRUITING
|
Russia | Saint-Petersburg City Hospital No.15 |
RECRUITING
|
Russia | Saratov Saratov State Medical University |
RECRUITING
|
Russia | St-Petersburg Clinical Research Institute of Hematology and Transfusiology |
RECRUITING
|
Russia | Syktyvkar Oncology Dispensary of Komi Republic |
RECRUITING
|
Poland | Legnica Wojewodzki Szpital Specjalistyczny w Legnicy |
ACTIVE_NOT_RECRUITING
|
Greece | Athens Attica Alexandra General Hospital of Athens |
ACTIVE_NOT_RECRUITING
|
Germany | Chemnitz, SN Klinikum Chemnitz gGmbH |
ACTIVE_NOT_RECRUITING
|
Germany | Hamburg, HH Asklepios Klinik Altona |
ACTIVE_NOT_RECRUITING
|
Germany | Tübingen, BW Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II, |
ACTIVE_NOT_RECRUITING
|
France | Caen Centre Hospitalier Universitaire (CHU) de Caen |
ACTIVE_NOT_RECRUITING
|
France | Nantes Cedex 1 CHU Nantes |
ACTIVE_NOT_RECRUITING
|
France | Paris Hopital Saint Louis |
ACTIVE_NOT_RECRUITING
|
France | Pessac Hôpital Haut-Lévêque |
ACTIVE_NOT_RECRUITING
|
Denmark | Aarhus N Aarhus University Hospital |
ACTIVE_NOT_RECRUITING
|
Belgium | Antwerpen ZNA Stuivenberg |
ACTIVE_NOT_RECRUITING
|
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Indicates < 10 sites in this region: click to zoom in.
Corresponds to individual site.