Last updated: 01/13/2026 08:46:57
Study to investigate alternative dosing regimens of belantamab mafodotin in participants with relapsed or refractory multiple myelomaDREAMM 14
EudraCT ID
EU CT Number
Trial status
Recruitment complete
Recruitment complete
Trial overview
Official title: A phase 2, randomized, parallel, open-label study to investigate the safety, efficacy, and pharmacokinetics of various dosing regimens of single-agent Belantamab Mafodotin (GSK2857916) in participants with relapsed or refractory multiple myeloma (DREAMM-14)
Trial description: This study aims to evaluate alternative dosing regimens of single-agent belantamab mafodotin in participants with relapsed or refractory multiple myeloma (RRMM) to determine if an improved overall benefit/risk profile can be achieved by modifying the belantamab mafodotin dose, schedule, or both.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Incidence rate of Grade ≥2 Corneal events according to the keratopathy visual acuity (KVA) scale
Timeframe: Up to 12 months
Secondary outcomes:
Cumulative event rate of corneal events to Week 16 (KVA scale)
Timeframe: Up to Week 16
Incidence rate of corneal events by grade (KVA scale)
Timeframe: Up to 12 months
Exposure adjusted incidence rate of corneal events by grade (KVA scale)
Timeframe: Up to 12 months
Median duration of dose delay
Timeframe: Up to 12 months
Percentage of participants requiring dose reductions, dose delays, and study treatment discontinuation due to corneal events
Timeframe: Up to 12 months
Cumulative incidence of corneal events by grade
Timeframe: Up to 12 months
Toxicity Index score by assessment/visit
Timeframe: Up to 12 months
Duration of corneal events
Timeframe: Up to 12 months
Percentage of time on study with corneal events
Timeframe: Up to 12 months
Change in best corrected visual acuity (BCVA)
Timeframe: Up to 12 months
Overall response rate (ORR)
Timeframe: Up to 12 months
Percentage of participants with very good partial response (VGPR) or better
Timeframe: Up to 12 months
Time to response (TTR)
Timeframe: Up to 12 months
Duration of response (DoR)
Timeframe: Up to 12 months
Time to progression (TTP)
Timeframe: Up to 12 months
Progression-free survival (PFS)
Timeframe: Up to 12 months
Overall survival (OS)
Timeframe: Up to 12 months
Number of participants with AEs and serious AEs (SAEs)
Timeframe: Up to 12 months
Number of participants with clinically significant changes in hematology, clinical chemistry and urinalysis laboratory parameters
Timeframe: Up to 12 months
Percentage of participants requiring dose reductions, dose delays, and study treatment discontinuation due to any AEs
Timeframe: Up to 12 months
Maximum concentration (Cmax) of belantamab mafodotin
Timeframe: Up to 12 months
Time taken to reach Cmax (Tmax) of belantamab mafodotin
Timeframe: Up to 12 months
Area under the concentration time-curve (AUC) of belantamab mafodotin
Timeframe: Up to 12 months
Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin
Timeframe: Up to 12 months
Titers of ADAs against belantamab mafodotin
Timeframe: Up to 12 months
Interventions:
Enrollment:
177
Primary completion date:
2024-19-08
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Multiple Myeloma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
March 2022 to January 2026
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Participant must be 18 years of age inclusive at the time of signing the informed consent form (ICF).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes), or active plasma cell leukemia at the time of screening.
- Current corneal epithelial disease, except nonconfluent superficial
Inclusion and exclusion criteria
Inclusion criteria:
- Participant must be 18 years of age inclusive at the time of signing the informed consent form (ICF).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Histologically or cytologically confirmed diagnosis of MM and a. Has undergone stem cell transplant or is considered transplant ineligible, and b. Has failed at least 3 prior lines of anti-myeloma therapies, including an anti-cluster of differentiation (CD)38 antibody (e.g., daratumumab) alone or in combination and is refractory to an immunomodulatory agent (e.g., lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib).
- France specific: participants have failed at least 4 prior lines of anti-myeloma therapies
- Participant has measurable disease per modified IMWG criteria.
- Life expectancy of at least 6 months, in the opinion of the investigator.
- Male and female participants agree to abide by protocol-defined contraceptive requirements.
- Participant is capable of giving signed informed consent.
- Participant meets country-specific inclusion criteria described in the protocol.
Exclusion criteria:
- Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes), or active plasma cell leukemia at the time of screening.
- Current corneal epithelial disease, except nonconfluent superficial punctate keratitis (SPK).
- Evidence of active mucosal or internal bleeding.
- Presence of an active renal condition.
- Any serious and/or unstable pre-existing medical condition, psychiatric disorder, or other conditions that could interfere with the participant’s safety, obtaining informed consent, or compliance with the study procedures.
- Malignancies other than the disease under study, except for any other malignancy from which the participant has been disease free for >2 years and, will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy (MM). Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.
- Evidence of cardiovascular risk as per the protocol criteria.
- Pregnant or lactating female.
- Active infection requiring antibiotic, antiviral, or antifungal treatment.
- Known human immunodeficiency virus (HIV) infection, unless the criteria in protocol can be met.
- Hepatitis B and C will be excluded unless the criteria in protocol can be met.
- Cirrhosis or current unstable liver or biliary disease.
- Alanine aminotransferase (ALT) >2.5× upper limit of normal (ULN).
- Total Bilirubin >1.5×ULN.
- Systemic anti-MM therapy within <=14 days or 5 half-lives, whichever is shorter.
- Systemic therapy with high dose steroids within <=14 days before the first dose of study treatment.
- Prior allogenic stem cell transplant.
- Prior treatment with a monoclonal antibody <=30 days before the first dose of study treatment. Use of monoclonal antibodies for serious conditions unrelated to multiple myeloma, such as COVID, may be permitted.
- Prior treatment with an anti-B cell maturation antigen (BCMA) targeted therapy or hypersensitivity reactions to any components of the study treatment.
- Treatment with an antibody-drug conjugate.
- Participant has received any major surgery <=4 weeks before the first dose of study treatment. An exception may be allowed for bone stabilizing surgery.
- Inadequate bone marrow reserve or organ functions as demonstrated by any of the following: a. Absolute neutrophil count <1.0×10^9/L, b. Hemoglobin <8 gram/deciliter (g/dL), c. Platelet count <50×10^9/L, d. Spot urine (albumin/creatinine ratio) >500 milligram/gram (mg/g), e. Estimated glomerular filtration rate (eGFR) <30 milliliter per minute per 1.73 meter square (mL/min/1.73m^2).
- UK specific: a. Absolute neutrophil count <1.5×10^9/L, c. Platelet count <75×10^9/L
Trial location(s)
Location
GSK Investigational Site
Stoke on Trent, United Kingdom, ST4 6QG
Status
Study Complete
Location
GSK Investigational Site
Capital Federal, Argentina, C1426ANZ
Status
Recruitment Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina, 1414
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, FL, United States, 33401
Status
Study Complete
Location
GSK Investigational Site
Cipoletti Rio Negro, Argentina, R8324CVE
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Knoxville, TN, United States, 38103
Status
Terminated/Withdrawn
Location
GSK Investigational Site
London, United Kingdom, SW17 0QT
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Spokane, WA, United States, 99218
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sushrut Hospital and Research, India, 400071
Status
Study Complete
Location
GSK Investigational Site
Gainesville, FL, United States, 34655
Status
Terminated/Withdrawn
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Recruitment complete
Actual primary completion date
2024-19-08
Actual study completion date
Not applicable
Plain language summaries
Summary of results in plain language
Available language(s): English, Bengali, French (Canadian), French, German, Greek, Gujarati, Hindi, Italian, Kannada, Korean, Malayalam, Marathi, Polish, Portuguese (Brazil), Punjabi, Spanish (Argentina), Spanish (Mexico), Spanish, Spanish (United States), Tamil (India), Telugu, Thai, Chinese (Taiwan), Urdu
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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