OncoMatch/Clinical Trials/NCT05714839
A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments
Is NCT05714839 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Unconjugated belantamab antibody and Belantamab mafodotin for multiple myeloma.
Treatment: Unconjugated belantamab antibody · Belantamab mafodotin · Unconjugated belantamab antibody and belantamab mafodotin · Unconjugated belantamab antibody in combination with pomalidomide-dexamethasone backbone, with or without belantamab mafodotin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: lenalidomide (lenalidomide)
Participants who have received at least 3 prior lines of anti-myeloma treatments, including lenalidomide, a proteasome inhibitor, and an anti-CD38 mAb either in combination or separately.
Must have received: proteasome inhibitor
Participants who have received at least 3 prior lines of anti-myeloma treatments, including lenalidomide, a proteasome inhibitor, and an anti-CD38 mAb either in combination or separately.
Must have received: anti-CD38 monoclonal antibody
Participants who have received at least 3 prior lines of anti-myeloma treatments, including lenalidomide, a proteasome inhibitor, and an anti-CD38 mAb either in combination or separately.
Cannot have received: allogeneic transplant
Prior allogeneic transplant is prohibited.
Cannot have received: radiotherapy
Prior radiotherapy within 2 weeks of start of study therapy.
Cannot have received: plasmapheresis
Plasmapheresis within 7 days prior to the first dose of study drug.
Cannot have received: CAR-T cell therapy
Exception: with lymphodepletion with chemotherapy within 3 months of screening
Participants who have received prior Chimeric Antigen Receptor T-cell therapy (CAR-T) therapy with lymphodepletion with chemotherapy within 3 months of screening.
Cannot have received: monoclonal antibody
Exception: within 30 days of receiving the first dose of study drugs
Prior treatment with a mAb within 30 days of receiving the first dose of study drugs
Cannot have received: systemic anti-myeloma therapy
Exception: within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is longer
treatment with an investigational agent or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is longer
Lab requirements
Blood counts
adequate organ system function as defined by the laboratory assessments
Kidney function
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 are eligible.
Liver function
adequate organ system function as defined by the laboratory assessments; has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice [excluded]
Cardiac function
Evidence of cardiovascular risk including any of the following: current clinically significant untreated arrhythmias, ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree AV block, history of MI, acute coronary syndromes (including unstable angina), coronary angioplasty, stenting or bypass grafting, all within three months of screening, Class III or IV heart failure as defined by NYHA, uncontrolled hypertension
Have adequate organ system function as defined by the laboratory assessments
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- GSK Investigational Site · Grand Rapids, Michigan
- GSK Investigational Site · Chapel Hill, North Carolina
- GSK Investigational Site · Chattanooga, Tennessee
- GSK Investigational Site · Nashville, Tennessee
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