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JOURNAL ONKOLOGIE – STUDIE

Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Rekrutierend

NCT-Nummer:
NCT04162210

Studienbeginn:
April 2020

Letztes Update:
19.04.2021

Wirkstoff:
Belantamab mafodotin, Pom/dex (Pomalidomide plus low dose Dexamethasone)

Indikation (Clinical Trials):
Multiple Myeloma, Neoplasms, Plasma Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
GlaxoSmithKline

Collaborator:
-

Studienleiter

GSK Clinical Trials
Study Director
GlaxoSmithKline

Kontakt

EU GSK Clinical Trials Call Center
Kontakt:
Phone: +44 (0) 20 89904466
E-Mail: GSKClinicalSupportHD@gsk.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 117)

GSK Investigational Site
72076 Tuebingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
13125 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
85715 Tucson
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
93105 Santa Barbara
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
81008 Pueblo
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
48202 Detroit
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
68130 Omaha
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
89169 Las Vegas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
12208-3479 Albany
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
45236 Cincinnati
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
97330 Corvallis
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
97401 Eugene
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
75230 Dallas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
75231 Dallas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
75702 Tyler
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
53226 Milwaukee
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
2250 Gosford
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
2065 St Leonards
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
2500 Wollongong
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
5011 Woodville
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
7000 Hobart
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
3168 Clayton
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
3065 Fitzroy
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
3220 Geelong
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
3004 Melbourne
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
6009 Nedlands
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
03021 St. Albans
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
8000 Brugge
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
1200 Bruxelles
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
2650 Edegem
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
9000 Gent
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
1090 Jette
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
8500 Kortrijk
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
5530 Yvoir
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
60115-281 Fortaleza
BrazilRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
80530-010 Curitiba
BrazilRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
90035-903 Porto Alegre
BrazilRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
90110-270 Porto Alegre
BrazilRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
21941-913 Rio de Janeiro
BrazilRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
22793-080 Rio de Janeiro
BrazilRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
01509-900 São Paulo
BrazilRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
04537-080 São Paulo
BrazilRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
5800 Pleven
BulgariaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
01431 Sofia
BulgariaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
1606 Sofia
BulgariaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
T6G 1Z2 Edmonton
CanadaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
72015 Le Mans
FranceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
34295 Montpellier
FranceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
86021 Poitiers cedex
FranceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
10676 Athens
GreeceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
115 28 Athens
GreeceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
12462 Haidari, Athens
GreeceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
41 110 Larisa
GreeceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
26500 Patra
GreeceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
54007 Thessaloniki
GreeceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
57010 Thessaloniki
GreeceRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
1083 Budapest
HungaryRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
1088 Budapest
HungaryRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
1097 Budapest
HungaryRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
7400 Kaposvár
HungaryRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
4400 Nyiregyhaza
HungaryRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
88100 Catanzaro
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
40138 Bologna
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
Ravenna
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com
» Ansprechpartner anzeigen
GSK Investigational Site
00161 Roma
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Alle anzeigen

Studien-Informationen

Brief Summary:

This open-label, randomized study for evaluating the efficacy and safety of single agent

belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be

randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex.

Belantamab mafodotin will be administered intravenously at 2.5 milligram (mg)/kilogram (kg)

on Day 1 (D1) of an every 3 weeks (Q3W) schedule. Pomalidomide will be administered orally at

the approved starting dose of 4 mg daily on Days 1 to 21 of each 28-day cycle, with

dexamethasone administered orally at a dose of 40 mg once weekly (Days 1, 8, 15, and 22).

Participants in both arms will be treated until disease progression, death, unacceptable

toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes

first. Approximately up to 380 participants will be randomized (320 + 60 to fulfill regional

country requirements).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Capable of giving signed informed consent.

- Participants must be 18 or older, at the time of signing the informed consent. In

Republic of Korea, participants must be over 19 years of age inclusive, at the time of

signing informed consent.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

- Histologically or cytologically confirmed diagnosis of Multiple myeloma (MM) as

defined according to IMWG, and : Has undergone autologous stem cell transplant (SCT),

or is considered transplant ineligible; Has received at least 2 prior lines of

anti-myeloma treatments, including at least 2 consecutive cycles of both lenalidomide

and a proteasome inhibitor (given separately or in combination), and must have

documented disease progression on, or within 60 days of, completion of the last

treatment as defined by IMWG.

- Has measurable disease with at least one of the following: Serum M-protein >=0.5 gram

per deciliter (g/dL) (>=5 gram per Liter); Urine M-protein >=200 mg/24 hours; Serum

free light chain (FLC) assay: Involved FLC level >=10 milligram per deciliter (mg/dL)

(>=100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).

- Participants with a history of autologous SCT are eligible for study participation

provided the following eligibility criteria are met: Transplant was >100 days prior to

initiating study treatment; No active infection(s).

- Adequate organ system functions as defined: Absolute neutrophil count (ANC)

>=1.0*10^9/L; Hemoglobin >= 8.0 g/dL; Platelets >= 50x10^9/L; Total bilirubin <=1.5*

Upper limit of normal (ULN) (isolated bilirubin >1.5*ULN is acceptable if bilirubin is

fractionated and direct bilirubin <35 percent); ALT <=2.5*ULN; Estimated glomerular

filtration rate (eGFR) >=30 milliliter per minute per 1.73 square meter (mL/min/1.73

m^2); Spot urine (albumin/creatinine ratios) <=500 milligram per gram (mg/g) (56

milligram per millimoles [mg/mmol]); Left ventricular ejection fraction (LVEF)

(echocardiogram) Clinically asymptomatic participants with ECHO confirmed LVEF>=25

percent

- Contraceptive use by men or women should be consistent with local regulations

regarding the methods of contraception for those participating in clinical studies.

Male participants are eligible to participate if they agree to the following during

the intervention period and until 5 months after the last dose of study intervention

to allow for clearance of any altered sperm: Refrain from donating sperm PLUS, either:

Be abstinent from heterosexual intercourse as their preferred and usual lifestyle

(abstinent on a long term and persistent basis) and agree to remain abstinent OR Must

agree to use contraception/barrier as detailed below depending on whether they are

randomised to Arm 1 (belantamab mafodotin) or Arm 2 (pom/dex), even if they have

undergone a successful vasectomy: Agree to use a male condom throughout study

treatment including the 5 month* follow-up period even if they have undergone a

successful vasectomy and a female partner to use an additional highly effective

contraceptive method with a failure rate of <1 percent per year when having sexual

intercourse with a pregnant woman or a woman of childbearing potential who is not

currently pregnant. * Four weeks for male participants on Treatment Arm 2 (pom/dex).

- A female participant is eligible to participate if she is not pregnant or

breastfeeding, and at least one of the following conditions applies: Is not a woman of

childbearing potential (WOCBP) OR Is a WOCBP and agrees to abide by the following: Arm

1 (belantamab mafodotin): Use a contraceptive method that is highly effective (with a

failure rate of <1 percent per year) which includes abstinence, preferably with low

user dependency during the intervention period and for 8 months after the last dose of

study treatment. Arm 2 (pom/dex): Due to pomalidomide being a thalidomide analogue

with risk for embryofetal toxicity and prescribed under a pregnancy

prevention/controlled distribution program, WOCBP participants will be eligible if

they commit either to abstain continuously from heterosexual sexual intercourse or to

use two methods of reliable birth control (one method that is highly effective),

beginning 4 weeks prior to initiating treatment with pomalidomide, during therapy,

during dose interruptions and continuing for at least 4 weeks following

discontinuation of pomalidomide treatment. Two negative pregnancy tests must be

obtained prior to initiating therapy. The first test should be performed within 10-14

days and the second test within 24 hours prior to prescribing pomalidomide therapy.

And agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during

this period. The investigator should confirm the effectiveness of the contraceptive

method(s) ahead of the first dose of study intervention.

- All prior treatment-related toxicities (defined by National Cancer Institute- Common

Toxicity Criteria for Adverse Events [NCI-CTCAE], version 5.0, 2017) must be <=Grade 1

at the time of enrollment, except for alopecia and Grade 2 peripheral neuropathy.

- In France, a participant will be eligible for inclusion in this study only if either

affiliated to or a beneficiary of a social security category.

Exclusion Criteria:

- Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly,

endocrinopathy, myeloma protein, and skin changes); active plasma cell leukemia at the

time of screening.

- Systemic anti-myeloma therapy or use of an investigational drug within <14 days or 5

half-lives, whichever is shorter, before the first dose of study intervention.

- Prior treatment with an anti-MM monoclonal antibody within 30 days prior to receiving

the first dose of study intervention.

- Prior B cell maturation antigen (BCMA)-targeted therapy or prior pomalidomide

treatment.

- Plasmapheresis within 7 days prior to the first dose of study intervention.

- Prior allogeneic stem cell transplant.

- Any major surgery within the last 4 weeks.

- Presence of active renal condition (infection, requirement for dialysis or any other

condition that could affect participant's safety). Participants with isolated

proteinuria resulting from MM are eligible, provided they fulfil criteria.

- Any serious and/or unstable pre-existing medical, psychiatric disorder, or other

conditions (including lab abnormalities) that could interfere with participant's

safety, obtaining informed consent, or compliance with study procedures.

- History of (non-infectious) pneumonitis that required steroids, or current

pneumonitis.

- Evidence of active mucosal or internal bleeding.

- Current unstable liver or biliary disease per investigator assessment defined by the

presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or

gastric varices, persistent jaundice, or cirrhosis.

- Participants with previous or concurrent malignancies other than multiple myeloma are

excluded, unless the second malignancy has been considered medically stable for at

least 2 years. The participant must not be receiving active therapy, other than

hormonal therapy for this disease.

- Evidence of cardiovascular risk including any of the following: QT interval corrected

for heart rate by Fridericia's formula (QTcF) >= 480 millisecond (msec); Evidence of

current clinically significant uncontrolled arrhythmias including clinically

significant electrocardiogram (ECG) abnormalities including 2nd degree (Mobitz Type

II) or 3rd degree atrioventricular block; History of myocardial infarction, acute

coronary syndromes (including unstable angina), coronary angioplasty, or stenting or

bypass grafting within 3 months of Screening; Class III or IV heart failure as defined

by the New York Heart Association (NYHA) functional classification system;

Uncontrolled hypertension.

- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs

chemically related to belantamab mafodotin, pomalidomide, dexamethasone or any of the

components of the study intervention.

- Pregnant or lactating female.

- Active infection requiring treatment.

- Known human immunodeficiency virus (HIV).

- Presence of hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb)

at screening or within 3 months prior to first dose of study intervention.

- Positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid

(RNA) test result at screening or within 3 months prior to first dose of study

intervention.

- Participants unable to tolerate thromboembolic prophylaxis.

Studien-Rationale

Primary outcome:

1. Progression-free survival (PFS) (Time Frame - Up to 20 months):
PFS, defined as the time from the date of randomization until the earliest date of documented disease progression (according to International Myeloma Working Group [IMWG] Response Criteria) or death due to any cause



Secondary outcome:

1. Overall survival (OS) (Time Frame - Up to 55 months):
OS, defined as the time from randomization until death due to any cause

2. Overall response rate (ORR) (Time Frame - Up to 55 months):
ORR, defined as the percentage of participants with a confirmed partial response (PR) or better per IMWG

3. Clinical benefit rate (CBR) (Time Frame - Up to 55 months):
CBR defined as the percentage of participants with a confirmed minimal response (MR) or better per IMWG

4. Duration of response (DoR) (Time Frame - Up to 55 months):
DoR, defined as the time from first documented evidence of PR or better until progressive disease (PD) per IMWG or death due to PD among participants who achieve confirmed PR or better

5. Time to response (TTR) (Time Frame - Up to 55 months):
TTR, defined as the time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve confirmed PR or better.

6. Time to progression (TTP) (Time Frame - Up to 55 months):
TTP, defined as the time from the date of randomization until the earliest date of documented PD (per IMWG Response Criteria) or death due to PD

7. Number of participants with adverse events (AEs) (Time Frame - Up to 55 months):
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly or birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.

8. Change from Baseline in hematology parameters: absolute white blood cell count (WBC), basophils,eosinophils, lymphocytes, monocytes, platelet count, and neutrophils (Giga cells per liter) (Time Frame - Baseline and up to 55 months):
Blood samples will be collected at indicated time-points for the analysis of hematology parameters

9. Change from Baseline in hematology parameters: Red Blood Cell (RBC) count and reticulocyte count (Trillion cells per liter) (Time Frame - Baseline and up to 55 months):
Blood samples will be collected at indicated time-points for the analysis of hematology parameters

10. Change from Baseline in hematology parameters: Mean Corpuscular Hemoglobin concentration (MCHC) and hemoglobin (Grams per Liter) (Time Frame - Baseline and up to 55 months):
Blood samples will be collected at indicated time-points for the analysis of hematology parameters

11. Change from Baseline in hematology parameters: Hematocrit (Proportion of red blood cells in blood) (Time Frame - Baseline and up to 55 months):
Blood samples will be collected at indicated time-points for the analysis of hematology parameters

12. Change from Baseline in hematology parameters: Mean Corpuscular Volume (MCV) [Femtoliter] (Time Frame - Baseline and up to 55 months):
Blood samples will be collected at indicated time-points for the analysis of hematology parameters

13. Change from Baseline in hematology parameters: Mean Corpuscular Hemoglobin (MCH) [Picograms] (Time Frame - Baseline and up to 55 months):
Blood samples will be collected at indicated time-points for the analysis of hematology parameters

14. Change from Baseline in clinical chemistry parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine kinase (CK), Gamma Glutamyl Transferase (GGT), and lactate dehydrogenase (LDH) (Time Frame - Baseline and up to 55 months):
Blood samples will be collected at indicated time-points for the analysis of clinical chemistry parameters like ALT, AST, ALP, CK, GGT, and LDH [International units per Liter]

15. Change from Baseline in clinical chemistry parameters: Calcium, chloride, glucose, potassium, sodium, magnesium, blood urea nitrogen (BUN), and phosphorous (Millimoles per Liter) (Time Frame - Baseline and up to 55 months):
Blood samples will be collected at indicated time-points for the analysis of clinical chemistry parameters

16. Change from Baseline in clinical chemistry parameters: Creatinine, direct bilirubin, total bilirubin, uric acid (Micromoles per liter) (Time Frame - Baseline and up to 55 months):
Blood samples will be collected at indicated time-points for the analysis of clinical chemistry parameters

17. Change from Baseline in clinical chemistry parameters: Albumin and total protein (Grams per Liter) (Time Frame - Baseline and up to 55 months):
Blood samples will be collected at indicated time-points for the analysis of clinical chemistry parameters

18. Change from Baseline in Urinalysis Parameter: Specific Gravity (Ratio) (Time Frame - Baseline and up to 55 months):
Urine samples will be collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity.

19. Change from Baseline in Urinalysis Parameters- Urine potential of hydrogen (pH) (Points on a scale) (Time Frame - Baseline and up to 55 months):
Urine samples will be collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).

20. Change from Baseline in urinalysis parameter: Glucose (Millimole per liter) (Time Frame - Baseline and up to 55 months):
Urine samples will be collected at indicated time points for the assessment of urinary glucose.

21. Change from Baseline in urinalysis parameter: Protein (Grams per liter) (Time Frame - Baseline and up to 55 months):
Urine samples will be collected at indicated time points for the assessment of urinary protein.

22. Change from Baseline in urinalysis parameter: Ketones (Millimoles per liter) (Time Frame - Baseline and up to 55 months):
Urine samples will be collected at indicated time points for the assessment of urinary ketones.

23. Change from Baseline in urinalysis parameter: blood (10^9 cells per liter) (Time Frame - Baseline and up to 55 months):
Urine samples will be collected at indicated time points for the assessment of urinary blood.

24. Change from Baseline in urinalysis parameter: creatinine/albumin ratio (ratio) (Time Frame - Baseline and up to 55 months):
Urine samples will be collected at indicated time points for the assessment of urinary creatinine/albumin ratio.

25. Number of participants with abnormal ocular findings (Time Frame - Up to 55 months):
Participants will be assessed for any abnormal ocular findings

26. Plasma concentrations of belantamab mafodotin (Time Frame - Up to 55 months):
Blood samples will be collected at indicated time points for the analysis

27. Plasma concentrations of total monoclonal antibody (mAb) (Time Frame - Up to 55 months):
Blood samples will be collected at indicated time points for the analysis

28. Plasma concentrations of cys-mc Microtubular inhibitor monomethyl auristatin-F (MMAF) (Time Frame - Up to 55 months):
Blood samples will be collected at indicated time points for the analysis

29. Number of participants with Anti-drug antibody (ADAs) against belantamab mafodotin (Time Frame - Up to 55 months):
Blood samples will be collected at indicated time points for the analysis

30. Titer of ADAs against belantamab mafodotin (Time Frame - Up to 55 months):
Blood samples will be collected at indicated time points for the analysis

31. Number of participants with symptomatic adverse effects measured by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) (Time Frame - Up to 55 months):
PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE.

32. Number of participants with symptomatic adverse effects measured by Ocular Surface Disease Index (OSDI) (Time Frame - Up to 55 months):
OSDI is a 12-item questionnaire designed to assesses both the frequency of dry eye symptoms and their impact on vision-related functioning

33. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core module (EORTC QLQC30) score (Time Frame - Up to 55 months):
The EORTC QLQ-C30 is a 30-item questionnaire containing both single- and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/quality of life (QoL) scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). Scores for each scale and single-item measure are averaged and transformed linearly to a score ranging from 0-100.

34. European Organization for Research and Treatment of Cancer IL52 (EORTC IL52) score (Time Frame - Up to 55 months):
The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. Disease Symptoms domain of the QLQ-MY20 will be used for bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity. QLQ-C30, QLQ-MY20 domain scores are averaged and transformed linearly to a score ranging from 0-100. A high score for Disease Symptoms represents a high level of symptomatology or problems

35. Rate of Minimal Residual Disease (MRD) (Time Frame - Up to 55 months):
MRD negativity rate, defined as; the percentage of participants who are MRD negative by Next generation sequencing (NGS) method

Studien-Arme

  • Experimental: Participants receiving Belantamab mafodotin
    Participants will receive belantamab mafodotin single agent dose of 2.5 mg/kg on Day 1 of Q3W
  • Active Comparator: Participants receiving pom/dex
    Participants will receive pomalidomide orally starting dose of 4 mg daily on Days 1 to 21 of each 28-cycle, with dexamethasone at an oral dose of 40 mg once weekly or a lower dose of 20 mg once weekly on Days 1, 8, 15 and 22.

Geprüfte Regime

  • Belantamab mafodotin:
    Belantamab mafodotin will be available as powder for solution for infusion which will be administered via intravenous (IV) route. Belantamab mafodotin will be reconstituted for injection 100 mg/vial with 2.0 milliliter (mL) of water for injection with dose level of 2.5 mg/kg.
  • Pom/dex (Pomalidomide plus low dose Dexamethasone):
    Pomalidomide will available as capsule and Dexamethasone will be available as tablet which will be administered via oral route.

Quelle: ClinicalTrials.gov


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