Trial Title:
A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments
NCT ID:
NCT05714839
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Lenalidomide
Conditions: Keywords:
Bela
Belamaf
Belatamab
Belantamab Mafodotin
Relapsed or Refractory Multiple Myeloma
Transplant-ineligible newly diagnosed multiple myeloma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Bela
Description:
Bela will be administered.
Arm group label:
Part 1 - Dose Escalation Phase in Participants with RRMM
Arm group label:
Part 2 - Combination Treatments in Participants with RRMM
Arm group label:
Part 3 - Combination Treatments in Participants with TI-NDMM
Other name:
Belantamab
Other name:
GSK2857914
Intervention type:
Drug
Intervention name:
Belamaf
Description:
Belamaf will be administered.
Arm group label:
Part 1 - Dose Escalation Phase in Participants with RRMM
Arm group label:
Part 2 - Combination Treatments in Participants with RRMM
Arm group label:
Part 3 - Combination Treatments in Participants with TI-NDMM
Other name:
Belantamab mafodotin
Other name:
GSK2857916 BLENREP
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Lenalidomide will be administered.
Arm group label:
Part 2 - Combination Treatments in Participants with RRMM
Arm group label:
Part 3 - Combination Treatments in Participants with TI-NDMM
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Dexamethasone will be administered.
Arm group label:
Part 2 - Combination Treatments in Participants with RRMM
Arm group label:
Part 3 - Combination Treatments in Participants with TI-NDMM
Intervention type:
Drug
Intervention name:
Standard of Care
Description:
Either standard of care (SoC) or an emerging treatment for Multiple Myeloma will be
administered
Arm group label:
Part 2 - Combination Treatments in Participants with RRMM
Arm group label:
Part 3 - Combination Treatments in Participants with TI-NDMM
Summary:
The study consists of three parts
- Part 1: The primary purpose of this part is to determine the safety, and recommended
part 2 dose of belantamab (bela) in participants with relapsed or refractory
multiple myeloma (RRMM).
- Part 2: The primary purpose of this part is to determine safety, tolerability and
percentage of adverse events (AEs) that happen to eyes in participants with RRMM
treated with bela in combination with other treatments.
- Part 3: The primary objective of this part is to assess the safety, tolerability and
rate of ocular AEs in participants with transplant-ineligible newly diagnosed
multiple myeloma (TI-NDMM) treated with either belantamab mafodotin (belamaf) or
bela in combination with other treatments.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participants at the time of signing the Informed Consent Form (ICF) are at least 18
years old or are of the legal age of consent in the jurisdiction in which the study
is taking place.
- Participants who have histologically or cytologically confirmed diagnosis of
Multiple Myeloma (MM), as defined by the IMWG, and measurable disease.
- PART 1: Participants who have received at least 3 prior lines of anti-myeloma
treatments, and have already received an immunomodulating agent, a proteasome
inhibitor, and an anti-CD38 mAb (unless contraindicated or unavailable). Lines of
therapy are defined by consensus panel of the International Myeloma Workshop.
- PART 2: Participants who meet all of the following:
- Have undergone Autologous stem cell transplant (ASCT) or are considered transplant
ineligible
- Have been previously treated with at least ONE prior line of MM therapy
- Have documented disease progression during or after their most recent therapy
- PART 3: Participants who meet both of the following:
- NDMM with a requirement for treatment as documented per IMWG criteria
- Not considered a candidate for high dose chemotherapy with ASCT due to:
1. Age ≥ 65 years OR
2. Age 18-65 years with presence of comorbid condition(s) likely to have a
negative impact on tolerability of high-dose chemotherapy with ASCT or who
refuse high-dose chemotherapy with ASCT as an initial treatment.
- Participants capable of giving signed informed consent, which includes compliance
with the requirements and restrictions listed in the ICF and protocol.
Exclusion Criteria:
- Diagnosis of primary Amyloid Light chain (AL) Amyloidosis, active Polyneuropathy,
organomegaly, endocrinopathy, myeloma protein, and skin changes (POEMS) syndrome,
primary plasma cell leukemia.
- 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.
- Active infection requiring antibiotic, antiviral, or antifungal treatment.
- Known, current drug or alcohol abuse.
- Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling,
or child) who is investigational site or Sponsor staff directly involved with this
trial, unless prospective Independent Review Board (IRB) approval (by chair or
designee) is allowing exception to this criterion for a specific participant.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
GSK Investigational Site
Address:
City:
Ciudadela
Zip:
B1702
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Jorge Solimano
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Fitzroy
Zip:
3065
Country:
Australia
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Hang Quach
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Bradley Augustson
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Salvador
Zip:
41253-190
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Edvan de Queiroz Crusoe
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
São Paulo
Zip:
04537-080
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Vania Hungria
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Aomori
Zip:
030-8553
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Kohmei Kubo
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Osaka
Zip:
545-8586
Country:
Japan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Teruhito Takakuwa
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Seoul, Korea
Zip:
137-701
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Chang Ki Min
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Seoul
Zip:
138-736
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Dok Hyun Yoon
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Mexico City
Zip:
01330
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Jorge Carlos Torres-Flores
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Gdansk
Zip:
80-214
Country:
Poland
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Agata Tyczynska
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Lublin
Zip:
20-081
Country:
Poland
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Marek Hus
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Changhua
Zip:
500
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Hsuan-Yu Lin
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
SHANG YI Huang
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Kayseri
Zip:
38039
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Ali Unal
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Leicester
Zip:
LE1 5WW
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Mamta Garg
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Oxford.
Zip:
OX3 7LE
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Karthik Ramasamy
Email:
Principal Investigator
Start date:
June 14, 2023
Completion date:
February 29, 2028
Lead sponsor:
Agency:
GlaxoSmithKline
Agency class:
Industry
Source:
GlaxoSmithKline
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05714839
