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
- Diseases
- Multiple myeloma
- 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
Sites (54)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GSK Investigational Site Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Capital Federal | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aire | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Pilar | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | East Melbourne | Australia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Liverpool | Australia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Newcastle | Australia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Woodville | Australia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Joinville | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Asklepios Kliniken Hamburg GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| Hospital General Universitario de Albacete Coordinator of this site? Confirm its status | Albacete | Spain | Completed |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital General Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Completed |
| Institut Català d'Oncologia Coordinator of this site? Confirm its status | Girona | Spain | Completed |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Completed |
| Fundacio Assistencial De Mutua De Terrassa Fpc Coordinator of this site? Confirm its status | Terrassa | Spain | Completed |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Centre Hospitalier D Avignon Coordinator of this site? Confirm its status | Avignon Cedex 9 | France | Completed |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice Cedex 2 | France | Completed |
| GSK Investigational Site Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Unknown status |
| Evangelismos S A Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Completed |
| Beaumont Hospital Coordinator of this site? Confirm its status | Dublin 9 | Ireland | Completed |
| Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria Coordinator of this site? Confirm its status | Alexandria | Italy | Completed |
| University Hospital Of Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Completed |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Completed |
| GSK Investigational Site Coordinator of this site? Confirm its status | Hwasun | South Korea | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Pusan | South Korea | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| GSK Investigational Site Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Khon Kaen | Thailand | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.