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JOURNAL ONKOLOGIE – STUDIE
DREAMM 14

Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma

Rekrutierend

NCT-Nummer:
NCT05064358

Studienbeginn:
März 2022

Letztes Update:
12.04.2023

Wirkstoff:
Belantamab mafodotin

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

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 103)

GSK Investigational Site
76133 Karlsruhe
(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
03048 Cottbus
(Brandenburg)
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
17475 Greifswald
(Mecklenburg-Vorpommern)
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
26133 Oldenburg
(Niedersachsen)
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
44137 Dortmund
(Nordrhein-Westfalen)
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
01307 Dresden
(Sachsen)
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
22763 Hamburg
(Hamburg)
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
34655 New Port Richey
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
33401 West Palm Beach
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
64114 Kansas City
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
10065 New York
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
37404 Chattanooga
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
37203 Nashville
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
77090 Houston
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
77090 Houston
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
99218 Spokane
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
C1426ANZ Capital Federal
ArgentinaRekrutierend» 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
S2002 Rosario
ArgentinaRekrutierend» 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
1414 Ciudad Autonoma de Buenos Aires
ArgentinaRekrutierend» 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
C1181ACH Ciudad Autonoma de Buenos Aires
ArgentinaRekrutierend» 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
2170 Liverpool
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
2298 Waratah
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
3002 East 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
41253-190 Salvador
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
80040-170 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
90850-170 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
89201-260 Joinville
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
22271-110 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
01236-030 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
L1G 2B9 Oshawa
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
M5G 2M9 Toronto
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
H2L 4M1 Montreal
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
H4J 1C5 Montréal
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
84902 Avignon cedex 9
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
72000 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
06189 Nice Cedex 2
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
45100 Orléans
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
42270 Saint-Priest en Jarez
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
106 76 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
11528 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
26504 Rio/Patras
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
422005 Nashik
IndiaRekrutierend» 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
380009 Ahmedabad
IndiaRekrutierend» 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
560054 Bangalore
IndiaRekrutierend» 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
500033 Hyderabad
IndiaRekrutierend» 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
682041 Kerala
IndiaRekrutierend» 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
700014 Kolkata
IndiaRekrutierend» Google-Maps
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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
700156 Kolkata
IndiaRekrutierend» Google-Maps
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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
400071 Mumbai
IndiaRekrutierend» Google-Maps
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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
605006 Pondicherry
IndiaRekrutierend» Google-Maps
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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
411004 Pune
IndiaRekrutierend» 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
8 Dublin
IrelandRekrutierend» Google-Maps
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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
D09 V2N0 Dublin
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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
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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
44124 Cona (FE)
ItalyRekrutierend» Google-Maps
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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
47014 Meldola
ItalyRekrutierend» Google-Maps
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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
42123 Reggio Emilia
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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
47900 Rimini
ItalyRekrutierend» Google-Maps
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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
16132 Genova
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
63100 Ascoli Piceno
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
15121 Alessandria
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

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Alle anzeigen

Studien-Informationen

Brief Summary:

This study aims to evaluate alternative dosing regimens of single-agent belantamab mafodotin

in participants with relapsed or refractory multiple myeloma (RRMM) to determine if an

improved overall benefit/risk profile can be achieved by modifying the belantamab mafodotin

dose, schedule, or both.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Participant must be 18 years of age inclusive at the time of signing the informed

consent form (ICF).

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

- Histologically or cytologically confirmed diagnosis of MM and a. Has undergone stem

cell transplant or is considered transplant ineligible, and b. Has failed at least 3

prior lines of anti-myeloma therapies, including an anti-cluster of differentiation

(CD)38 antibody (e.g., daratumumab) alone or in combination and is refractory to an

immunomodulatory agent (e.g., lenalidomide, pomalidomide) and a proteasome inhibitor

(e.g., bortezomib, ixazomib, carfilzomib).

- France specific: participants have failed at least 4 prior lines of anti-myeloma

therapies

- Participant has measurable disease per modified IMWG criteria.

- Life expectancy of at least 6 months, in the opinion of the investigator.

- Male and female participants agree to abide by protocol-defined contraceptive

requirements.

- Participant is capable of giving signed informed consent.

- Participant meets country-specific inclusion criteria described in the protocol.

Exclusion Criteria:

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

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

the time of screening.

- Current corneal epithelial disease, except nonconfluent superficial punctate keratitis

(SPK).

- Evidence of active mucosal or internal bleeding.

- Presence of an active renal condition.

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

other conditions that could interfere with the participant's safety, obtaining

informed consent, or compliance with the study procedures.

- Malignancies other than the disease under study, except for any other malignancy from

which the participant has been disease free for >2 years and, will not affect the

evaluation of the effects of the study treatment on the currently targeted malignancy

(MM). Participants with curatively treated non-melanoma skin cancer may be enrolled

without a 2-year restriction.

- Evidence of cardiovascular risk as per the protocol criteria.

- Pregnant or lactating female.

- Active infection requiring antibiotic, antiviral, or antifungal treatment.

- Known human immunodeficiency virus (HIV) infection, unless the criteria in protocol

can be met.

- Hepatitis B and C will be excluded unless the criteria in protocol can be met.

- Cirrhosis or current unstable liver or biliary disease.

- Alanine aminotransferase (ALT) >2.5× upper limit of normal (ULN).

- Total Bilirubin >1.5×ULN.

- Systemic anti-MM therapy within <=14 days or 5 half-lives, whichever is shorter.

- Systemic therapy with high dose steroids within <=14 days before the first dose of

study treatment.

- Prior allogenic stem cell transplant.

- Prior treatment with a monoclonal antibody <=30 days before the first dose of study

treatment. Use of monoclonal antibodies for serious conditions unrelated to multiple

myeloma, such as COVID, may be permitted.

- Prior treatment with an anti-B cell maturation antigen (BCMA) targeted therapy or

hypersensitivity reactions to any components of the study treatment.

- Treatment with an antibody-drug conjugate.

- Participant has received any major surgery <=4 weeks before the first dose of study

treatment. An exception may be allowed for bone stabilizing surgery.

- Inadequate bone marrow reserve or organ functions as demonstrated by any of the

following: a. Absolute neutrophil count <1.0×10^9/L, b. Hemoglobin <8 gram/deciliter

(g/dL), c. Platelet count <50×10^9/L, d. Spot urine (albumin/creatinine ratio) >500

milligram/gram (mg/g), e. Estimated glomerular filtration rate (eGFR) <30 milliliter

per minute per 1.73 meter square (mL/min/1.73m^2).

- UK specific: a. Absolute neutrophil count <1.5×10^9/L, c. Platelet count <75×10^9/L

Studien-Rationale

Primary outcome:

1. Incidence rate of Grade ≥2 Corneal events according to the keratopathy visual acuity (KVA) scale (Time Frame - Up to 12 months):
KVA scale is used to grade the corneal events from Grade 0-4. KVA grading is a composite score considering corneal exam findings (ranging from clear cornea [Grade 0] to corneal ulcer [Grade 4]), as well as changes in visual acuity (ranging from no change from Baseline in visual acuity [Grade 0] to visual acuity worse than 1.0 logarithm of the minimum angle of resolution ([logMAR] (20/200) [Grade 4]). The KVA grade is driven by the most severe finding.



Secondary outcome:

1. Cumulative event rate of corneal events to Week 16 (KVA scale) (Time Frame - Up to Week 16)

2. Incidence rate of corneal events by grade (KVA scale) (Time Frame - Up to 12 months):
KVA scale is used to grade the corneal events from Grade 0-4. KVA grading is a composite score considering corneal exam findings (ranging from clear cornea [Grade 0] to corneal ulcer [Grade 4]), as well as changes in visual acuity (ranging from no change from Baseline in visual acuity [Grade 0] to visual acuity worse than 1.0 logMAR (20/200) [Grade 4]). The KVA grade is driven by the most severe finding.

3. Exposure adjusted incidence rate of corneal events by grade (KVA scale) (Time Frame - Up to 12 months):
The exposure adjusted incidence rate is defined as the number of participants with corneal events divided by the total exposure in subject years among participants in the respective treatment group at risk of an initial occurrence of the event.

4. Median duration of dose delay (Time Frame - Up to 12 months):
Median duration of dose delay is defined as the median duration in time of all the dose delays in the respective treatment group.

5. Percentage of participants requiring dose reductions, dose delays, and study treatment discontinuation due to corneal events (Time Frame - Up to 12 months)

6. Cumulative incidence of corneal events by grade (Time Frame - Up to 12 months):
Cumulative incidence of corneal events by grade is calculated using the KVA scale, as the number of new events divided by the total number of individuals in the population at risk for a specific time interval.

7. Toxicity Index score by assessment/visit (Time Frame - Up to 12 months):
Toxicity Index score is defined as a function of the ordered toxicity grades, where the toxicity grades are represented in descending order by the sequence.

8. Duration of corneal events (Time Frame - Up to 12 months):
Duration of corneal events is defined as the sum of the duration of all the corneal events of a participant.

9. Percentage of time on study with corneal events (Time Frame - Up to 12 months):
Percentage of time on study with corneal events is defined as the duration of corneal events divided by the total amount of time that a participant is on the study in percentage.

10. Change in best corrected visual acuity (BCVA) (Time Frame - Up to 12 months):
BCVA will be assessed as per Snellen (or Snellen-equivalent) chart.

11. Overall response rate (ORR) (Time Frame - Up to 12 months):
Percentage of participants with a confirmed partial response (PR) or better per International Myeloma Working Group (IMWG) criteria.

12. Percentage of participants with very good partial response (VGPR) or better (Time Frame - Up to 12 months)

13. Time to response (TTR) (Time Frame - Up to 12 months):
Time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve confirmed PR or better.

14. Duration of response (DoR) (Time Frame - Up to 12 months):
Time from first documented evidence of PR or better until progressive disease (PD) per IMWG or death due to any cause.

15. Time to progression (TTP) (Time Frame - Up to 12 months):
Time from the date of randomization until the earliest date of documented PD (per IMWG Response Criteria) or death due to PD.

16. Progression-free survival (PFS) (Time Frame - Up to 12 months):
Time from the date of randomization until the earliest date of documented PD (according to IMWG Response Criteria) or death due to any cause.

17. Overall survival (OS) (Time Frame - Up to 12 months):
Time from the date of randomization until death due to any cause.

18. Number of participants with AEs and serious AEs (SAEs) (Time Frame - Up to 12 months)

19. Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis laboratory parameters (Time Frame - Up to 12 months)

20. Percentage of participants requiring dose reductions, dose delays, and study treatment discontinuation due to any AEs (Time Frame - Up to 12 months)

21. Maximum concentration (Cmax) of belantamab mafodotin (Time Frame - Up to 12 months)

22. Time taken to reach Cmax (Tmax) of belantamab mafodotin (Time Frame - Up to 12 months)

23. Area under the concentration time-curve (AUC) of belantamab mafodotin (Time Frame - Up to 12 months)

24. Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin (Time Frame - Up to 12 months)

25. Titers of ADAs against belantamab mafodotin (Time Frame - Up to 12 months)

Studien-Arme

  • Experimental: Cohort 1: Participants receiving belantamab mafodotin at dose level (DL) 1
  • Experimental: Cohort 2: Participants receiving belantamab mafodotin at DL 2
  • Experimental: Cohort 3: Participants receiving belantamab mafodotin at DL 3
  • Experimental: Cohort 4: Participants receiving belantamab mafodotin at DL 4
  • Experimental: Cohort 5: Participants receiving belantamab mafodotin at DL4 with alternative dose modification

Geprüfte Regime

  • Belantamab mafodotin:
    Belantamab mafodotin will be administered.

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma"

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