Phase
Condition
Cancer/tumors
Lymphoproliferative Disorders
Platelet Disorders
Treatment
JNJ-63723283
Daratumumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) in any order during the course oftreatment for multiple myeloma or have disease that is refractory to both a PI andan IMiD
Evidence of a response (partial response [PR] or better based on investigator'sdetermination of response by International Myeloma Working Group [IMWG] criteria) toat least 1 prior treatment regimen
Documented measurable disease for multiple myeloma at screening as defined inprotocol
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
Contraceptive use by men or women should be consistent with local regulationsregarding the use of contraceptive methods for participants participating inclinical studies
Exclusion
Exclusion Criteria:
Received any of the following prescribed medications or therapies in the past:Anti-CD38 antibody, including daratumumab, and/or Anti-PD-1 (programmed death-1) andanti-PD-L1 (programmed death-ligand 1) antibodies
Plans to undergo a stem cell transplant prior to progression of disease on thisstudy (these participants should not be enrolled to reduce disease burden prior totransplant)
History of malignancy (other than multiple myeloma) within 2 years prior to firstadministration of study drug (exceptions are squamous and basal cell carcinomas ofthe skin and carcinoma in situ of the cervix, or malignancy that in the opinion ofthe investigator, with concurrence with the sponsor's medical monitor, is consideredcured with minimal risk of recurrence within 3 years)
Clinical signs of meningeal involvement of multiple myeloma
Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volumein 1 second (FEV1) <50% of predicted normal or known moderate or severe persistentasthma within the past 2 years, or uncontrolled asthma of any classification
Study Design
Study Description
Connect with a study center
ZNA Stuivenberg
Antwerpen, 2060
BelgiumSite Not Available
Algemeen Ziekenhuis Klina
Brasschaat, 2930
BelgiumSite Not Available
AZ St.-Jan Brugge-Oostende AV
Brugge, 8000
BelgiumSite Not Available
UZBrussel
Brussel, 1090
BelgiumSite Not Available
UZA
Edegem, 2650
BelgiumSite Not Available
UZ Gent
Gent, 9000
BelgiumSite Not Available
Az Groeninge
Kortrijk, 8500
BelgiumSite Not Available
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
Instituto Do Cancer Do Ceara
Fortaleza, 60430-230
BrazilSite Not Available
Instituto D'Or de Pesquisa e Ensino (IDOR)
Rio De Janeiro, 22271-110
BrazilSite Not Available
Hospital Santa Cruz
São Paulo, 04122-000
BrazilSite Not Available
CHU de Limoges, Hopital Dupuytren
Limoges, 87042
FranceSite Not Available
Institut Paoli Calmettes
Marseille Cedex 9,
FranceSite Not Available
CHU de Montpellier, Hopital Saint-Eloi
Montpellier, 34295
FranceSite Not Available
Chu Rennes - Hopital Pontchaillou
Rennes Cedex, 35033
FranceSite Not Available
CHU de Tours - Hôpital de Bretonneau
Tours Cedex 9, 37044
FranceSite Not Available
Helios Kliniken Berlin Buch Gmbh
Berlin, 13125
GermanySite Not Available
Asklepios Klinik Altona
Hamburg, 22763
GermanySite Not Available
Klinische Forschung Hannover -Mitte
Hannover, 30159
GermanySite Not Available
Institut für Versorgungsforschung
Koblenz, 56068
GermanySite Not Available
Universitätsmedizin der Johannes Gutenberg Universität
Mainz, 55131
GermanySite Not Available
Klinikum der Eberhard-Karls-Universität / Abt. für innere Med. II / Hämatologie/Onkologie - German
Tübingen, 72076
GermanySite Not Available
Alexandra General Hospital of Athens
Athens Attica, 115 28
GreeceSite Not Available
Carmel Hospital
Haifa, 34362
IsraelSite Not Available
Rambam Medical Center
Haifa, 31096
IsraelSite Not Available
Hadassah Medical Center
Jerusalem, 91120
IsraelSite Not Available
Rabin Medical Center
Petah-Tiqva, 49100
IsraelSite Not Available
Sheba Medical Center
Ramat-Gan, 52621
IsraelSite Not Available
Sourasky Medical Center
Tel-Aviv, 6423906
IsraelSite Not Available
City clinical hospital n.a. S.P.Botkin
Moscow, 125284
Russian FederationSite Not Available
Nizhniy Novgorod Region Clinical Hospital
Nizhny Novgorod, 603126
Russian FederationSite Not Available
Ryazan Regional Clinical Hospital
Ryazan, 390003
Russian FederationSite Not Available
Samara Region Clinical Hospital
Samara, 443095
Russian FederationSite Not Available
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916
SpainSite Not Available
Hosp. Clinic I Provincial de Barcelona
Barcelona, 08036
SpainSite Not Available
Hosp. Univ. 12 de Octubre
Madrid, 28041
SpainSite Not Available
Clinica Univ. de Navarra
Pamplona, 31008
SpainSite Not Available
Ankara Universitesi Tip Fakultesi
Ankara, 06590
TurkeySite Not Available
Trakya University Medical Faculty
Edirne, 22030
TurkeySite Not Available
Dokuz Eylul Universitesi Tip Fakultesi
Izmir, 35340
TurkeySite Not Available
Ondokuz Mayis Universitesi Tip Fakultesi
Samsun, 55200
TurkeySite Not Available
Mayo Clinic
Jacksonville, Florida 32224
United StatesSite Not Available
Emory University - Winship Cancer Institute
Atlanta, Georgia 30322
United StatesSite Not Available
Norton Healthcare
Louisville, Kentucky 40202
United StatesSite Not Available
Tufts Medical Center
Boston, Massachusetts 02111
United StatesSite Not Available
Mayo Clinic - Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
Shivers Cancer Center
Austin, Texas 78701
United StatesSite Not Available
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