JOURNAL ONKOLOGIE – STUDIE

DREAMM5

Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

Studienbeginn:
Oktober 2019

Letztes Update:
26.02.2024

Wirkstoff:
Belantamab mafodotin, GSK3174998, feladilimab, Nirogacestat, Dostarlimab, Isatuximab, Lenalidomide, Dexamethasone, Pomalidomide

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

US GSK Clinical Trials Call Center
Kontakt:
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com» Kontaktdaten anzeigen

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

Studienlocations
(3 von 59)

GSK Investigational Site
60590 Frankfurt am Main
(Hessen)
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
04103 Leipzig
(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
24105 Kiel
(Schleswig-Holstein)
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
20246 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
30322 Atlanta
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
46202 Indianapolis
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
02215 Boston
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
49546 Grand Rapids
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
78229 San Antonio
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
53792 Madison
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
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
3000 Melbourne
AustraliaAbgeschlossen» Google-Maps

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
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
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
05652-900 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
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
V5Z1M9 Vancouver
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
B3H 1V7 Halifax
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
59037 Lille 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
69373 Lyon cedex 08
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
40000 Mont-de-Marsan
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
94805 Villejuif 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
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
31096 Haifa
IsraelRekrutierend» 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
49100 Petach Tikva
IsraelRekrutierend» 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
6423906 Tel Aviv
IsraelRekrutierend» 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
467-8602 Aichi
JapanRekrutierend» 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
790-8524 Ehime
JapanRekrutierend» 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
150-8935 Tokyo
JapanRekrutierend» 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
21565 Incheon
Korea, Republic ofRekrutierend» 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
03080 Seoul
Korea, Republic ofRekrutierend» 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
06351 Seoul
Korea, Republic ofRekrutierend» 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
06591 Seoul
Korea, Republic ofRekrutierend» 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
44033 Ulsan
Korea, Republic ofRekrutierend» 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
01330 Mexico City
MexicoRekrutierend» 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
1081 HV Amsterdam
NetherlandsZurückgezogen» Google-Maps

GSK Investigational Site
3318 AT Dordrecht
NetherlandsRekrutierend» 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
7512 KZ Enschede
NetherlandsRekrutierend» 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
8934 AD Leeuwarden
NetherlandsRekrutierend» 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
3584 CX Utrecht
NetherlandsRekrutierend» 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
0450 Oslo
NorwayRekrutierend» 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
80-214 Gdansk
PolandRekrutierend» 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
40-519 Katowice
PolandRekrutierend» 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
93-513 Lodz
PolandRekrutierend» 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
20-081 Lublin
PolandRekrutierend» 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
60-569 Poznan
PolandRekrutierend» 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
125284 Moscow
Russian FederationRekrutierend» 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
191024 St'Petersburg
Russian FederationRekrutierend» 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
08916 Badalona
SpainRekrutierend» 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
28027 Madrid
SpainRekrutierend» 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
28040 Madrid
SpainRekrutierend» 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
28041 Madrid
SpainRekrutierend» 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
31008 Pamplona
SpainRekrutierend» 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
28223 Pozuelo (Madrid)
SpainRekrutierend» 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
SE-791 82 Falun
SwedenRekrutierend» 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
SE-141 86 Stockholm
SwedenRekrutierend» 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

Alle anzeigen

Studien-Informationen

Brief Summary:

B-cell maturation antigen (BCMA) is a target present on tumor cells in participants with

multiple myeloma. Belantamab mafodotin (GSK2857916); is an antibody-drug conjugate (ADC)

containing humanized anti-BCMA monoclonal antibody (mAb). This is a phase I/II, randomized,

open-label, platform study designed to evaluate the effects of belantamab mafodotin in

combination with other anti-cancer drugs in participants with relapsed/refractory multiple

myeloma. The Platform design incorporates a single master protocol, where multiple treatment

combinations, as sub-studies, will be evaluated simultaneously.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Participant must be 18 years of age inclusive or older, at the time of signing the

informed consent.

- Participants must have histologically or cytologically confirmed diagnosis of Multiple

Myeloma (MM), as defined by the IMWG.

- Participants having at least 3 prior lines of prior anti-myeloma treatments including

an immunomodulating agent (IMID) a proteasome inhibitor (PI) and an anti-CD38

monoclonal antibody.

- Participants with a history of autologous stem cell transplant are eligible for study

participation when, transplant was >100 days prior to study enrolment and with no

active infection(s).

- Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1,

unless ECOG less than equal to (<=)2 is due solely to skeletal complications and/or

skeletal pain due to MM.

- Participants with measurable disease defined as at least one of the following: Serum

M-protein greater than equal to (>=)0.5 gram per deciliter (>=5 gram per liter) or

Urine M-protein >=200 milligrams (mg) per 24 hours or Serum free light chain (FLC)

assay: Involved FLC level >=10 mg per deciliter (>=100 mg per Liter) and an abnormal

serum FLC ratio (<0.26 or >1.65).

- Participants who have tested positive for Hepatitis B core antibody (HBcAb) can be

enrolled if the following criteria are met: Serology result HBcAb+, Hepatitis B

surface antigen (HBsAg)-; HBV deoxyribonucleic acid (DNA) undetectable during

screening.

- Participants who are currently receiving physiological doses oral steroids (<10

mg/day), inhaled steroids or ophthalmalogical steroids.

Inclusion Criteria Specific to Sub-study 6,7, and 8:

- Participants with contraception requirements specific to Sub-study 6, 7, and 8

respectively.

- Participants with platelets value for Adequate Organ System Function is ≥75 × 10^9/L.

Inclusion Criteria Specific to Sub-study 8:

- In Japan, participants should reside in Japan and be Japanese as defined by having all

biological Japanese grandparents. Similarly, in China, subjects should reside in China and

be Chinese as defined by having all biological Chinese grandparents.

Exclusion Criteria:

- Participants with current corneal epithelial disease except mild punctate keratopathy.

- Participants with evidence of cardiovascular risk.

- Participants with known immediate or delayed hypersensitivity reaction or idiosyncrasy

to drugs chemically related to belantamab mafodotin or any of the components of the

study treatment. History of severe hypersensitivity to other mAb.

- Participants with active infection requiring antibiotic, antiviral, or antifungal

treatment.

- Participants with other monoclonal antibodies within 30 days or systemic anti-myeloma

therapy within <14 days.

- Participants with prior radiotherapy within 2 weeks of start of study therapy.

- Participants with prior allogeneic transplant are prohibited.

- Participants who have received prior Chimeric Antigen T cell therapy (CAR-T) therapy

with lymphodepletion with chemotherapy within 3 months of screening.

- Participants with any major surgery (other than bone-stabilizing surgery) within the

last 30 days.

- Participants with prior treatment with an investigational agent within 14 days or 5

half-lives of receiving the first dose of study drugs, whichever is shorter.

- Participants with >=grade 3 toxicity considered related to prior check-point

inhibitors and that led to treatment discontinuation.

- Participants who have received transfusion of blood products within 2 weeks before the

first dose of study drug.

- Participants must not receive live attenuated vaccines within 30 days prior to first

dose of study treatment or whilst receiving belantamab mafodotin +- partner agent in

any sub-study arm of the platform trial and for at least 70 days following last study

treatment.

- Participants with 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.

- Participants with known human immunodeficiency virus (HIV) infection, unless the

participant can meet all criteria: a) established anti-retroviral therapy for at least

4 weeks and HIV viral load<400 copies/milliliter (mL) b) cluster of differentiation 4

plus (CD4+) T-cell (CD4+) counts >= 350 cells/microliter (µL) c) No history of

Acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the

last 12 months in which case the participant would be eligible for CE Phase only.

For participants receiving nirogacestat, HIV drugs that are strong Cytochrome P450 3A4

(CYP3A4) inhibitors are prohibited. HIV drugs that are moderate CYP3A4 inhibitors, while

permitted, should be co-administered with caution and must be accompanied by nirogacestat

dose modifications.

Additional Exclusion Criteria for Sub-study 1 and 2:

- Participants with autoimmune disease (current or history) or syndrome that required

systemic treatment within the past 2 years.

- Exclusion for a recent (within the past 6 months) history of symptomatic pericarditis.

Additional Exclusion Criteria for Sub-study 3, 6, 7, and 8:

- Participants with uncontrolled small and/or large intestinal disease.

- Participants with uncontrolled skin disease.

- Participants with any condition causing hypophosphatemia, hypokalemia or

hypomagnesemia which is refractory to electrolyte replacement.

- Participants with previous administration of a gamma secretase inhibitor.

- Participants with concomitant administration of a strong CYP3A4 inhibitor or inducer.

Additional Exclusion Criteria for Sub-study 4:

- Participant has an active autoimmune disease that has required systemic treatment in

the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or

immunosuppressive drugs).

- Participants who have received prior therapy with an anti-programmed death-1

(anti-PD-1), anti-PD-1-ligand-1 (anti-PD-L1), or anti-PD-1 ligand-2 (anti-PD-L2)

agent.

- Participant has a diagnosis of immunodeficiency or is receiving systemic steroid

therapy or any other form of immunosuppressive therapy within 7 days prior to the

first dose of study treatment. Use of inhaled steroids, local injection of steroids,

and steroid eye drops are allowed.

Additional Exclusion Criteria for Sub-study 5:

- Participants with Severe hypersensitivity to Isatuximab-irfc or to any of its

excipients.

- Participants with prior treatment with other anti-CD38 monoclonal antibody within 6

months of the first dose of study drug treatment.

- Participants with known intolerance or hypersensitivity to infused proteins products,

sucrose, histidine, and polysorbate 80.

Additional Exclusion Criteria for Sub-study 6, 7, and 8:

- Participants with active or history of venous thromboembolism within the past 3

months.

- Participants with evidence of active mucosal or internal bleeding.

- Participants with contraindications to or are unwilling to undergo protocol-required

anti-thrombotic prophylaxis or unable to tolerate antithrombolitic prophalaxis.

Additional Exclusion Criteria for Sub-study 6 and 8:

- Participants who discontinued prior treatment with lenalidomide due to intolerable

adverse events.

Additional Exclusion Criteria for Sub-study 7:

- Participants who discontinued prior treatment with pomalidomide due to intolerable

adverse events.

Additional Exclusion Criteria for Sub-study 8:

- Pregnant or lactating female or female who are interrupting lactation.

- Previously diagnosed with interstitial lung disease or current complication of

interstitial lung disease.

Studien-Rationale

Primary outcome:

1. DE Phase: Number of participants achieving dose limiting toxicities (DLT) (Time Frame - Up to 12 months):
An event is considered to be a DLT if the event occurs within the first 28 days of treatment and meets protocol defined DLT criteria.

2. DE Phase: Number of participants with adverse events (AEs) and serious adverse events (SAEs) (Time Frame - Up to 12 months):
AEs and SAEs will be collected.

3. DE Phase: Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis lab parameters (Time Frame - Up to 12 months):
Blood and urine samples will be collected to evaluate hematology, clinical chemistry and urinalysis lab parameters.

4. CE Phase: Number of participants achieving Overall Response Rate (ORR) (Time Frame - Up to 36 months):
ORR is defined as the percentage of participants with a Partial response (PR) or better, according to the International Myeloma Working Group (IMWG) Response Criteria.

Secondary outcome:

1. DE Phase: Number of participants achieving ORR (Time Frame - Up to 12 months):
ORR is defined as the percentage of participants with PR or better, according to the IMWG Response Criteria.

2. CE Phase: Number of participants achieving Clinical Benefit Rate (CBR) (Time Frame - Up to 36 months):
CBR is defined as the percentage of participants with a minimal response (MR) or better, according to IMWG response criteria.

3. DE Phase: Number of participants achieving Partial Response (PR) (Time Frame - Up to 12 months):
Number of participants with PR according to IMWG criteria will be analyzed.

4. CE Phase: Number of participants achieving PR (Time Frame - Up to 36 months):
Number of participants with PR according to IMWG criteria will be analyzed.

5. DE Phase: Number of participants achieving Very Good Partial Response (VGPR) (Time Frame - Up to 12 months):
Number of participants with VGPR according to IMWG criteria will be analyzed.

6. CE Phase: Number of participants achieving VGPR (Time Frame - Up to 36 months):
Number of participants with VGPR according to IMWG criteria will be analyzed.

7. DE Phase: Number of participants achieving Complete Response (CR) (Time Frame - Up to 12 months):
Participants with CR according to IMWG criteria will be analyzed.

8. CE Phase: Number of participants achieving CR (Time Frame - Up to 36 months):
Participants with CR according to IMWG criteria will be analyzed.

9. DE Phase: Number of participants achieving stringent Complete Response (sCR) (Time Frame - Up to 12 months):
Participants with sCR according to IMWG criteria will be analyzed.

10. CE Phase: Number of participants achieving sCR (Time Frame - Up to 36 months):
Participants with sCR according to IMWG criteria will be analyzed.

11. DE Phase: Belantamab mafodotin concentrations when administered in combination with anti-cancer treatments (Time Frame - Up to 12 months):
Blood samples will be collected for concentrations of belantamab mafodotin.

12. CE Phase: Belantamab mafodotin concentrations when administered in combination with anti-cancer treatments (Time Frame - Up to 36 months):
Blood samples will be collected for concentrations of belantamab mafodotin.

13. DE Phase: GSK3174998 concentration when administered in combination with belantamab mafodotin (Time Frame - Up to 12 months):
Blood samples will be collected for concentrations of GSK3174998.

14. CE Phase: GSK3174998 concentration when administered in combination with belantamab mafodotin (Time Frame - Up to 36 months):
Blood samples will be collected for concentrations of GSK3174998.

15. DE Phase: Feladilimab concentration when administered in combination with belantamab mafodotin (Time Frame - Up to 12 months):
Blood samples will be collected for concentrations of feladilimab.

16. CE Phase: Feladilimab concentration when administered in combination with belantamab mafodotin (Time Frame - Up to 36 months):
Blood samples will be collected for concentrations of feladilimab.

17. DE Phase: Nirogacestat concentration when administered in combination with belantamab mafodotin (Time Frame - Up to 12 months):
Blood samples will be collected for concentrations of nirogacestat.

18. CE Phase: Nirogacestat concentration when administered in combination with belantamab mafodotin (Time Frame - Up to 36 months):
Blood samples will be collected for concentrations of nirogacestat.

19. DE Phase: Dostarlimab concentration when administered in combination with belantamab mafodotin (Time Frame - Up to 12 months):
Blood samples will be collected for concentrations of dostarlimab.

20. CE Phase: Dostarlimab concentration when administered in combination with belantamab mafodotin (Time Frame - Up to 36 months):
Blood samples will be collected for concentrations of dostarlimab.

21. DE Phase: Isatuximab concentration when administered in combination with belantamab mafodotin (Time Frame - Up to 12 months):
Blood samples will be collected for concentrations of isatuximab.

22. CE Phase: Isatuximab concentration when administered in combination with belantamab mafodotin (Time Frame - Up to 36 months):
Blood samples will be collected for concentrations of isatuximab.

23. DE Phase: Concentration of anti-drug antibodies (ADAs) against belantamab mafodotin when administered in combination with anti-cancer treatments (Time Frame - Up to 12 months):
Blood samples for concentrations for ADAs will be collected.

24. CE Phase: Concentration of ADAs against belantamab mafodotin when administered in combination with anti-cancer treatments (Time Frame - Up to 36 months):
Blood samples for concentrations for ADAs will be collected.

25. DE Phase: Concentration of ADAs against GSK3174998 when administered in combination with belantamab mafodotin (Time Frame - Up to 12 months):
Blood samples for concentrations for ADAs will be collected.

26. CE Phase: Concentration of ADAs against GSK3174998 when administered in combination with belantamab mafodotin (Time Frame - Up to 36 months):
Blood samples for concentrations for ADAs will be collected.

27. DE Phase: Concentration of ADAs against feladilimab when administered in combination with belantamab mafodotin (Time Frame - Up to 12 months):
Blood samples for concentrations for ADAs will be collected.

28. CE Phase: Concentration of ADAs against feladilimab when administered in combination with belantamab mafodotin (Time Frame - Up to 36 months):
Blood samples for concentrations for ADAs will be collected.

29. DE Phase: Concentration of ADAs against dostarlimab when administered in combination with belantamab mafodotin (Time Frame - Up to 12 months):
Blood samples for concentrations for ADAs will be collected.

30. CE Phase: Concentration of ADAs against dostarlimab when administered in combination with belantamab mafodotin (Time Frame - Up to 36 months):
Blood samples for concentrations for ADAs will be collected.

31. DE Phase: Concentration of ADAs against isatuximab when administered in combination with belantamab mafodotin (Time Frame - Up to 12 months):
Blood samples for concentrations for ADAs will be collected.

32. CE Phase: Concentration of ADAs against isatuximab when administered in combination with belantamab mafodotin (Time Frame - Up to 36 months):
Blood samples for concentrations for ADAs will be collected.

33. DE Phase: Number of participants with adverse events of special interest (AESI) for belantamab mafodotin (Time Frame - Up to 12 months):
AESIs will be collected.

34. CE Phase: Number of participants with AESI for belantamab mafodotin (Time Frame - Up to 36 months):
AESIs will be collected.

35. DE Phase: Number of participants with AESI for GSK3174998 (Time Frame - Up to 12 months):
AESIs will be collected.

36. CE Phase: Number of participants with AESI for GSK3174998 (Time Frame - Up to 36 months):
AESIs will be collected.

37. DE Phase: Number of participants with AESI for Feladilimab (Time Frame - Up to 12 months):
AESIs will be collected.

38. CE Phase: Number of participants with AESI for Feladilimab (Time Frame - Up to 36 months):
AESIs will be collected.

39. DE Phase: Number of participants with AESI for Nirogacestat (Time Frame - Up to 12 months):
AESIs will be collected.

40. CE Phase: Number of participants with AESI for Nirogacestat (Time Frame - Up to 36 months):
AESIs will be collected.

41. DE Phase: Number of participants with AESI for Dostarlimab (Time Frame - Up to 12 months):
AESIs will be collected.

42. CE Phase: Number of participants with AESI for Dostarlimab (Time Frame - Up to 36 months):
AESIs will be collected.

43. DE Phase: Number of participants with AESI for Isatuximab (Time Frame - Up to 12 months):
AESIs will be collected.

44. CE Phase: Number of participants with AESI for Isatuximab (Time Frame - Up to 36 months):
AESIs will be collected.

45. DE Phase: Number of participants with abnormal ocular findings on ophthalmic examination (Time Frame - Up to 12 months):
Ophthalmic examination will assess abnormal findings.

46. CE Phase: Number of participants with abnormal ocular findings on ophthalmic examination (Time Frame - Up to 36 months):
Ophthalmic examination will assess abnormal findings.

47. CE Phase: Number of participants achieving Progression-free survival (PFS) (Time Frame - Up to 36 months):
PFS is defined as the time from randomization until the earliest date of confirmed progressive disease (PD) per IMWG, or death due to any cause.

48. CE Phase: Duration of response (DoR) (Time Frame - Up to 36 months):
DoR is defined as the time from first documented evidence or PR or better until progressive disease per IMWG or death due to progressive disease among participants who achieve confirmed partial response or better.

49. CE Phase: Time to response (TTR) (Time Frame - Up to 36 months):
TTR is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (confirmed PR or better).

50. CE Phase: Number of participants achieving Overall survival (OS) (Time Frame - Up to 36 months):
OS is defined as the time from randomization until death due to any cause.

51. CE Phase: Number of participants with AEs and SAEs (Time Frame - Up to 36 months):
AEs and SAEs will be collected.

52. CE Phase: Number of participants with AEs leading to discontinuation (Time Frame - Up to 36 months):
Number of participants with AEs leading to discontinuation will be evaluated.

53. CE Phase: Number of participants with dose reduction or delay (Time Frame - Up to 36 months):
Number of participants with dose reduction or delay will be evaluated.

54. CE Phase: Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis lab parameters (Time Frame - Up to 36 months):
Blood and urine samples will be collected to evaluate hematology, clinical chemistry and urinalysis lab parameters.

Studien-Arme

Experimental: Belantamab mafodotin+GSK3174998 dose exploration (Sub-study 1)
Experimental: Belantamab mafodotin+feladilimab dose exploration (Sub-study 2)
Experimental: Belantamab mafodotin+nirogacestat dose exploration(Sub-study 3)
Experimental: Belantamab mafodotin+dostarlimab dose exploration(Sub-study 4)
Experimental: Belantamab mafodotin+isatuximab dose exploration (Sub-study 5)
Experimental: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone dose exploration (Sub-study 6)
Experimental: Belantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone dose exploration (Sub-study 7)
Experimental: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone dose exploration (Sub-study 8)
This cohort will enroll Northeast Asian participants.
Active Comparator: Belantamab mafodotin monotherapy cohort expansion
Experimental: Belantamab mafodotin+GSK3174998 cohort expansion (Sub-study 1)
Experimental: Belantamab mafodotin+ feladilimab cohort expansion (Sub-study 2)
Experimental: Belantamab mafodotin+ nirogacestat cohort expansion (Sub-study 3)
Experimental: Belantamab mafodotin+ dostarlimab cohort expansion (Sub-study 4)
Experimental: Belantamab mafodotin+ isatuximab cohort expansion (Sub-study 5)
Experimental: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone cohort expansion (Sub-study 6)
Experimental: Belantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone cohort expansion (Sub-study 7)
Experimental: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone cohort expansion (Sub-study 8)
This cohort will enroll Northeast Asian participants.

Geprüfte Regime

Belantamab mafodotin:
Belantamab mafodotin will be administered.
GSK3174998:
GSK3174998 will be administered.
Feladilimab:
feladilimab will be administered.
Nirogacestat:
Nirogacestat will be administered.
Dostarlimab:
Dostarlimab will be administered.
Isatuximab:
Isatuximab will be administered.
Lenalidomide:
Lenalidomide will be administered.
Dexamethasone:
Dexamethasone will be administered.
Pomalidomide:
Pomalidomide will be administered.

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

"Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)"

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