A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) - DREAMM 5

Who is this study for? Patients with Multiple Myeloma
What treatments are being studied? Belantamab Mafodotin
Status: Active_not_recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

• 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.

Locations
United States
Georgia
GSK Investigational Site
Atlanta
Indiana
GSK Investigational Site
Indianapolis
Massachusetts
GSK Investigational Site
Boston
Michigan
GSK Investigational Site
Grand Rapids
Wisconsin
GSK Investigational Site
Madison
Other Locations
Australia
GSK Investigational Site
Fitzroy
GSK Investigational Site
Melbourne
Brazil
GSK Investigational Site
Porto Alegre
GSK Investigational Site
Salvador
GSK Investigational Site
Sao Paulo
Canada
GSK Investigational Site
Halifax
GSK Investigational Site
Toronto
GSK Investigational Site
Vancouver
France
GSK Investigational Site
Lille
GSK Investigational Site
Villejuif Cedex
Germany
GSK Investigational Site
Frankfurt
GSK Investigational Site
Hamburg
GSK Investigational Site
Kiel
GSK Investigational Site
Leipzig
Greece
GSK Investigational Site
Athens
Mexico
GSK Investigational Site
Ciudad De Mexico
Netherlands
GSK Investigational Site
Leeuwarden
GSK Investigational Site
Utrecht
Norway
GSK Investigational Site
Oslo
Poland
GSK Investigational Site
Katowice
GSK Investigational Site
Lublin
Republic of Korea
GSK Investigational Site
Incheon
GSK Investigational Site
Seoul
GSK Investigational Site
Seoul
GSK Investigational Site
Seoul
GSK Investigational Site
Ulsan
Russian Federation
GSK Investigational Site
Moscow
Spain
GSK Investigational Site
Badalona
GSK Investigational Site
Madrid
GSK Investigational Site
Madrid
GSK Investigational Site
Madrid
GSK Investigational Site
Pamplonanavarra
GSK Investigational Site
Pozuelo De Alarcon Madr
Sweden
GSK Investigational Site
Falun
GSK Investigational Site
Stockholm
Time Frame
Start Date: 2019-10-07
Completion Date: 2029-02-12
Participants
Target number of participants: 209
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov