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NCT05064358CompletedPhase 2

Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma

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)

Source: ClinicalTrials.gov · Last updated 5 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
177 (actual)
First submitted
22 Sept 2021
Start date
3 Mar 2022
Primary completion date
19 Aug 2024
Lead sponsor
GlaxoSmithKline
NCT number
NCT05064358
EU CT number
2023-508213-16-00
EudraCT number
2021-004151-16

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 177
  • From 3 Mar 2022 to the primary completion date, 19 Aug 2024
  • 54 sites in 18 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.
  • 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.

Lab values

  • Alanine aminotransferase (ALT) \>2.5× upper limit of normal (ULN).
  • Total Bilirubin \>1.5×ULN.
  • 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

Age

  • 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.

Other

  • Evidence of cardiovascular risk as per the protocol criteria.
  • Pregnant or lactating female.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (54)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
GSK Investigational Site
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Buenos AiresArgentinaUnknown status
GSK Investigational Site
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Capital FederalArgentinaUnknown status
GSK Investigational Site
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Ciudad Autonoma de Buenos AireArgentinaUnknown status
GSK Investigational Site
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PilarArgentinaUnknown status
GSK Investigational Site
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RosarioArgentinaUnknown status
GSK Investigational Site
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East MelbourneAustraliaUnknown status
GSK Investigational Site
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LiverpoolAustraliaUnknown status
GSK Investigational Site
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NewcastleAustraliaUnknown status
GSK Investigational Site
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WoodvilleAustraliaUnknown status
GSK Investigational Site
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JoinvilleBrazilUnknown status
GSK Investigational Site
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Porto AlegreBrazilUnknown status
GSK Investigational Site
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Rio de JaneiroBrazilUnknown status
GSK Investigational Site
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SalvadorBrazilUnknown status
GSK Investigational Site
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São PauloBrazilUnknown status
GSK Investigational Site
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MontrealCanadaUnknown status
GSK Investigational Site
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BernSwitzerlandUnknown status
Asklepios Kliniken Hamburg GmbH
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HamburgGermanyCompleted
Hospital General Universitario de Albacete
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AlbaceteSpainCompleted
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainCompleted
Hospital General Universitario Reina Sofia
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CórdobaSpainCompleted
Institut Català d'Oncologia
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GironaSpainCompleted
Hospital Universitario Central De Asturias
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OviedoSpainCompleted
Fundacio Assistencial De Mutua De Terrassa Fpc
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TerrassaSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
Centre Hospitalier D Avignon
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Avignon Cedex 9FranceCompleted
Centre Antoine Lacassagne
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Nice Cedex 2FranceCompleted
GSK Investigational Site
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LeicesterUnited KingdomUnknown status
GSK Investigational Site
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LondonUnited KingdomUnknown status
GSK Investigational Site
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Stoke-on-TrentUnited KingdomUnknown status
Evangelismos S A
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AthensGreeceCompleted
Alexandra Hospital
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AthensGreeceCompleted
University General Hospital Attikon
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AthensGreeceCompleted
General University Hospital Of Patras
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PatrasGreeceCompleted
Beaumont Hospital
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Dublin 9IrelandCompleted
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
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AlexandriaItalyCompleted
University Hospital Of Ferrara
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FerraraItalyCompleted
IRCCS Ospedale Policlinico San Martino
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GenoaItalyCompleted
GSK Investigational Site
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HwasunSouth KoreaUnknown status
GSK Investigational Site
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PusanSouth KoreaUnknown status
GSK Investigational Site
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SeoulSouth KoreaUnknown status
GSK Investigational Site
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Mexico CityMexicoUnknown status
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandCompleted
GSK Investigational Site
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BangkokThailandUnknown status
GSK Investigational Site
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Chiang MaiThailandUnknown status
GSK Investigational Site
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Khon KaenThailandUnknown status
GSK Investigational Site
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TaichungTaiwanUnknown status
GSK Investigational Site
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TainanTaiwanUnknown status
GSK Investigational Site
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TaipeiTaiwanUnknown status
GSK Investigational Site
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ChattanoogaUnited StatesUnknown status
GSK Investigational Site
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HoustonUnited StatesUnknown status
GSK Investigational Site
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Kansas CityUnited StatesUnknown status
GSK Investigational Site
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NashvilleUnited StatesUnknown status
GSK Investigational Site
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New YorkUnited StatesUnknown status
GSK Investigational Site
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West Palm BeachUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.