A Study of Daratumumab

Last Updated   April 24, 2024 - 21:04

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OVERVIEW

  • Gender
    all
  • Age
    - years
  • Phase
    phase 3
    The 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
    43 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

Locations in:
United States, Ukraine, Spain, South Korea, Russia, Poland, Greece, Germany, France, Denmark, Belgium
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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5

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