Actively Recruiting
A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments
Led by GlaxoSmithKline · Updated on 2026-01-23
153
Participants Needed
27
Research Sites
337 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study consists of three parts: * Part 1 The primary purpose of this part aims to evaluate the safety, tolerability, and clinical activity of escalating doses of single agent Unconjugated belantamab antibody in participants with refractory multiple myeloma (RRMM) who have received at least 3 prior therapies (4L+). * Part 2 The primary purpose of this part is to evaluate the safety, tolerability, and clinical activity of different dose ratios of belantamab mafodotin in combination with Unconjugated belantamab antibody (delivered as separate drugs) in participants with RRMM who have received at least 3 prior therapies (4L+). * Part 3: The Primary purpose of this part will evaluate the clinical activity of a selected dose of the unconjugated belantamab antibody, either alone or in combination with belantamab mafodotin alongside the standard of care (SoC) pomalidomide-dexamethasone backbone. The study will focus on patients with multiple myeloma who have undergone at least one prior line of therapy, including treatment with lenalidomide.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants are at least 18 years old or meet legal consent age
- Diagnosed with multiple myeloma confirmed by international criteria
- Part 1 and 2 participants have received at least 3 prior anti-myeloma treatments including lenalidomide, a proteasome inhibitor, and an anti-CD38 monoclonal antibody
- Part 3 participants have received at least 1 prior anti-myeloma treatment including lenalidomide; no more than 70% may be anti-CD38 naive
- Autologous stem cell transplant occurred more than 100 days before screening
- No active bacterial, viral, or fungal infections
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Measurable disease as defined by serum or urine M-protein levels or serum free light chain assay
- Adequate organ function per laboratory tests
- Prior treatment toxicities are grade 1 or less except alopecia, neuropathy (grade 2 or less), or managed endocrinopathies
- Ability to provide signed informed consent
- Women not pregnant or breastfeeding and use effective contraception as required
- For Part 3, participants of child-bearing potential must follow specific contraception requirements due to pomalidomide risks
You will not qualify if you...
- Diagnosis of primary AL amyloidosis, POEMS syndrome, or primary plasma cell leukemia
- Active or recent venous/arterial thromboembolism (Part 3)
- Serious or unstable medical or psychiatric conditions affecting safety or consent
- Signs of meningeal or CNS involvement with multiple myeloma
- Current corneal epithelial disease except nonconfluent superficial punctate keratitis
- Cirrhosis or unstable liver/biliary disease
- Other active malignancies except disease-free for over 2 years or stable non-metastatic prostate or breast cancer on hormone therapy
- Significant cardiovascular risks including certain arrhythmias or recent major cardiac events
- Uncontrolled hypertension
- Known severe allergies to study drugs or related monoclonal antibodies
- Active infections requiring treatment
- Hepatitis B or C infection not meeting criteria
- HIV infection unless specific criteria met
- Recent gastrointestinal diseases (within 6 months)
- Active renal conditions affecting safety
- Prior refractory or recent belantamab mafodotin treatment restrictions
- Recent radiotherapy or plasmapheresis
- Prior allogeneic transplant or recent CAR-T therapy
- Recent major surgery or incomplete recovery
- Recent treatment with monoclonal antibodies, investigational agents, or systemic anti-myeloma therapies
- Recent transfusions or colony stimulating factors (Part 1)
- Prior use of study drugs or pomalidomide in Part 3
- No live vaccines within 30 days before or during treatment
- Known drug or alcohol abuse
- Immediate family members involved in the study team unless approved
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
GSK Investigational Site
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
2
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
3
GSK Investigational Site
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
4
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Actively Recruiting
5
GSK Investigational Site
Ciudadela, Argentina, B1702
Completed
6
GSK Investigational Site
San Juan Bautista, Argentina, B1888AAE
Actively Recruiting
7
GSK Investigational Site
Viedma, Argentina, R8500ACE
Actively Recruiting
8
GSK Investigational Site
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
9
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Completed
10
GSK Investigational Site
Joinville, Brazil, 89201-260
Actively Recruiting
11
GSK Investigational Site
Salvador, Brazil, 41253-190
Actively Recruiting
12
GSK Investigational Site
São Paulo, Brazil, 04537-080
Actively Recruiting
13
GSK Investigational Site
Aomori, Japan, 030-8553
Actively Recruiting
14
GSK Investigational Site
Chiba, Japan, 277-8577
Actively Recruiting
15
GSK Investigational Site
Osaka, Japan, 545-8586
Completed
16
GSK Investigational Site
Tokyo, Japan, 105-8471
Actively Recruiting
17
GSK Investigational Site
Gdansk, Poland, 80-214
Withdrawn
18
GSK Investigational Site
Lublin, Poland, 20-081
Actively Recruiting
19
GSK Investigational Site
Seoul, South Korea, 137-701
Actively Recruiting
20
GSK Investigational Site
Seoul, South Korea, 138-736
Actively Recruiting
21
GSK Investigational Site
Changhua, Taiwan, 500
Actively Recruiting
22
GSK Investigational Site
Taipei, Taiwan, 100
Actively Recruiting
23
GSK Investigational Site
Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
24
GSK Investigational Site
Kayseri, Turkey (Türkiye), 38039
Actively Recruiting
25
GSK Investigational Site
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
26
GSK Investigational Site
Oxford, United Kingdom, OX3 7LE
Completed
27
GSK Investigational Site
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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