A Phase 3, Randomized, Open-label Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)

Status: Recruiting
Location: See all (80) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this Phase 3 study is to evaluate if BRd prolongs progression free survival (PFS) and/or improves minimal residual disease (MRD) negative status compared with DRd in participants with TI-NDMM.

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

• Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.

• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the protocol.

• NDMM with a requirement for treatment as documented per IMWG criteria.

• Must have at least 1 aspect of measurable disease, as assessed by the central laboratory, defined as 1 of the following:

∙ Urine M-protein excretion ≥200 mg/24 hours (≥0.2 g/24 hours) And/or

‣ Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L) And/or

‣ Serum free light-chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (\<0.26 or \>1.65).

• Newly diagnosed and not considered candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to any of the following:

∙ ≥70 years of age, OR

‣ Age 18 to 69 years with presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT, (or for whom national guidelines do not permit transplant due to a cut-off age below 70 years), OR

‣ Who refuse high-dose chemotherapy with ASCT as an initial treatment.

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

• Adequate organ system function as defined by the laboratory assessments.

• Male participants:

‣ Contraceptive use by men 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 Treatment Period and for at least 6 months after the last dose of study intervention to allow for clearance of any altered sperm:

⁃ Refrain from donating fresh unwashed semen

• 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

⁃ Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \<1% per year when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. Male participants should also use a condom when having sexual intercourse with pregnant females.

• Female participants

‣ Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

⁃ A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:

⁃ Is not a WOCBP OR

⁃ Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency during the Treatment Period and for 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.

⁃ A WOCBP must have 2 negative highly sensitive serum pregnancy tests before starting treatment, the first may be performed within 14 days from C1D1, the second within 24 hours before the first dose of study intervention.

⁃ Should pregnancy occur in a female on treatment or the female partner of a male on treatment, treatment must be stopped, and it is advised to seek advice from a physician specialized or experienced in teratology.

Locations
United States
Alabama
GSK Investigational Site
RECRUITING
Mobile
Texas
GSK Investigational Site
RECRUITING
Kingwood
Other Locations
Argentina
GSK Investigational Site
RECRUITING
Capital Federal
GSK Investigational Site
RECRUITING
Ciudad Autonoma De Buenos Aire
GSK Investigational Site
RECRUITING
Córdoba
GSK Investigational Site
RECRUITING
Rosario
GSK Investigational Site
RECRUITING
Viedma
Australia
GSK Investigational Site
RECRUITING
Box Hill
GSK Investigational Site
RECRUITING
Fitzroy
GSK Investigational Site
RECRUITING
Gosford Nsw
Belgium
GSK Investigational Site
RECRUITING
Bruges
GSK Investigational Site
RECRUITING
Brussels
GSK Investigational Site
RECRUITING
Ghent
GSK Investigational Site
RECRUITING
Hornu
GSK Investigational Site
RECRUITING
Roeselare
China
GSK Investigational Site
RECRUITING
Beijing
GSK Investigational Site
RECRUITING
Guangzhou
GSK Investigational Site
RECRUITING
Nanchang
GSK Investigational Site
RECRUITING
Nanchang
GSK Investigational Site
RECRUITING
Nanjing
GSK Investigational Site
RECRUITING
Shanghia
GSK Investigational Site
RECRUITING
Shenzhen
GSK Investigational Site
RECRUITING
Tianjin
GSK Investigational Site
RECRUITING
Wenzhou
France
GSK Investigational Site
RECRUITING
Bobigny
GSK Investigational Site
RECRUITING
Nantes
GSK Investigational Site
RECRUITING
Villejuif
Germany
GSK Investigational Site
RECRUITING
Dresden
Greece
GSK Investigational Site
RECRUITING
Alexandroupoli
GSK Investigational Site
RECRUITING
Athens
GSK Investigational Site
RECRUITING
Athens
GSK Investigational Site
RECRUITING
Athens
GSK Investigational Site
RECRUITING
Pátrai
GSK Investigational Site
RECRUITING
Thessaloniki
Ireland
GSK Investigational Site
RECRUITING
Dublin
GSK Investigational Site
RECRUITING
Waterford
Italy
GSK Investigational Site
RECRUITING
Ancona
GSK Investigational Site
RECRUITING
Meldola Fc
GSK Investigational Site
RECRUITING
Roma
Japan
GSK Investigational Site
RECRUITING
Aichi
GSK Investigational Site
RECRUITING
Ehime
GSK Investigational Site
RECRUITING
Ehime
GSK Investigational Site
RECRUITING
Fukuoka
GSK Investigational Site
RECRUITING
Fukushima
GSK Investigational Site
RECRUITING
Gunma
GSK Investigational Site
RECRUITING
Hyōgo
GSK Investigational Site
RECRUITING
Hyōgo
GSK Investigational Site
RECRUITING
Ibaraki
GSK Investigational Site
RECRUITING
Ishikawa
GSK Investigational Site
RECRUITING
Kanagawa
GSK Investigational Site
RECRUITING
Miyagi
GSK Investigational Site
RECRUITING
Nara
GSK Investigational Site
RECRUITING
Numakunai
GSK Investigational Site
RECRUITING
Sapporo
GSK Investigational Site
RECRUITING
Suita
GSK Investigational Site
RECRUITING
Tokyo
GSK Investigational Site
RECRUITING
Yamagata
Poland
GSK Investigational Site
RECRUITING
Lublin
Republic of Korea
GSK Investigational Site
RECRUITING
Hwasun
GSK Investigational Site
RECRUITING
Jeonju
GSK Investigational Site
RECRUITING
Seoul
GSK Investigational Site
RECRUITING
Seoul
GSK Investigational Site
RECRUITING
Seoul
GSK Investigational Site
RECRUITING
Seoul
GSK Investigational Site
RECRUITING
Seoul
GSK Investigational Site
RECRUITING
Ulsan
Spain
GSK Investigational Site
RECRUITING
Badalona
GSK Investigational Site
RECRUITING
Barcelona
GSK Investigational Site
RECRUITING
Gijón
GSK Investigational Site
RECRUITING
Madrid
GSK Investigational Site
RECRUITING
Madrid
GSK Investigational Site
RECRUITING
Madrid
GSK Investigational Site
RECRUITING
Málaga
GSK Investigational Site
RECRUITING
Murcia
GSK Investigational Site
RECRUITING
Salamanca
GSK Investigational Site
RECRUITING
Santander
GSK Investigational Site
RECRUITING
Valladolid
Taiwan
GSK Investigational Site
RECRUITING
Kaohsiung City
GSK Investigational Site
RECRUITING
Taipei
United Kingdom
GSK Investigational Site
RECRUITING
Plymouth
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2024-12-27
Estimated Completion Date: 2032-04-06
Participants
Target number of participants: 520
Treatments
Experimental: Arm A: Belantamab Mafodotin + Lenalidomide + Dexamethasone
Belantamab mafodotin, lenalidomide, and dexamethasone will be administered.~Treatment will continue in both arms until progressive disease (PD), death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.
Active_comparator: Arm B: Daratumumab + Lenalidomide + Dexamethasone
Daratumumab, lenalidomide, and dexamethasone will be administered.~Treatment will continue in both arms until PD, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov

Similar Clinical Trials