Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Estudo de Belantamab Mafodotin Plus Standard of Care (SoC) em Mieloma Múltiplo Recentemente Diagnosticado (DREAMM 9)

6 de novembro de 2026 atualizado por: GlaxoSmithKline

Um estudo de avaliação de fase 1, randomizado, de dose e esquema para investigar a segurança, farmacocinética, farmacodinâmica e atividade clínica de Belantamab Mafodotin administrado em combinação com tratamento padrão em participantes com mieloma múltiplo recém-diagnosticado

This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants with newly diagnosed multiple myeloma (NDMM). Participants will receive the combination of bortezomib, lenalidomide and dexamethasone (VRd) on a 3-week cycle until cycle 8, followed by the combination of lenalidomide and dexamethasone (Rd) on a 4-week cycle thereafter as per dosing schedule. Participants will receive belantamab mafodotin on a schedule that is dependent on the cohort to which they are assigned. Belantamab mafodotin will be administered in combination with VRd every 3 weeks (Q3W), every 6 weeks (Q6W), or every 9 weeks (Q9W) to Cycle 8, and then in combination with Rd every 4 weeks (Q4W), every 8 weeks (Q8W), or every 12 weeks (Q12W) thereafter. Participants will complete an End of Treatment (EOT) visit at the point of study treatment discontinuation, followed by a Safety Follow-up visit 70 days after EOT.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Mieloma múltiplo

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

118

Estágio

Fase 1

Acesso expandido

Aprovado para venda ao público. Consulte registro de acesso expandido.

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Alemanha
- - Dresden, Alemanha, 01307
    - GSK Investigational Site
  - Hamburg, Alemanha, 20246
    - GSK Investigational Site
  - Schwerin, Alemanha, 19049
    - GSK Investigational Site
  - Tübingen, Alemanha, 72076
    - GSK Investigational Site
Austrália
- New South Wales
  - Newcastle, New South Wales, Austrália, 2298
    - GSK Investigational Site
- Victoria
  - Clayton, Victoria, Austrália, 3168
    - GSK Investigational Site
  - Fitzroy, Victoria, Austrália, 3065
    - GSK Investigational Site
Canadá
- Alberta
  - Edmonton, Alberta, Canadá, T6G 1Z2
    - GSK Investigational Site
- Ontario
  - London, Ontario, Canadá, N6A 5W9
    - GSK Investigational Site
Coréia do Sul
- - Seoul, Coréia do Sul, 03080
    - GSK Investigational Site
  - Seoul, Coréia do Sul, 03722
    - GSK Investigational Site
  - Seoul, Coréia do Sul, 137-701
    - GSK Investigational Site
Espanha
- - Barcelona, Espanha, 08036
    - GSK Investigational Site
  - Madrid, Espanha, 28027
    - GSK Investigational Site
  - Málaga, Espanha, 29010
    - GSK Investigational Site
  - PamplonaNavarra, Espanha, 31008
    - GSK Investigational Site
  - Pozuelo de AlarcOn Madr, Espanha, 28223
    - GSK Investigational Site
  - Santander, Espanha, 39008
    - GSK Investigational Site
- Barcelona
  - Badalona, Barcelona, Espanha, 08916
    - GSK Investigational Site
Estados Unidos
- Kansas
  - Westwood, Kansas, Estados Unidos, 66205
    - GSK Investigational Site
- North Carolina
  - Charlotte, North Carolina, Estados Unidos, 28204
    - GSK Investigational Site
- Wisconsin
  - Madison, Wisconsin, Estados Unidos, 53792-0001
    - GSK Investigational Site
França
- - Poitiers, França, 86021
    - GSK Investigational Site
Itália
- - Bologna, Itália, 40138
    - GSK Investigational Site
  - Meldola FC, Itália, 47014
    - GSK Investigational Site
Polônia
- - Lublin, Polônia, 20-081
    - GSK Investigational Site
  - Poznan, Polônia, 61-848
    - GSK Investigational Site
Reino Unido
- - Leicester, Reino Unido, LE1 5WW
    - GSK Investigational Site
  - Oxford, Reino Unido, OX3 7LE
    - GSK Investigational Site
- Hampshire
  - Southampton, Hampshire, Reino Unido, SO16 6YD
    - GSK Investigational Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

Participant must be over 18 years of age inclusive, at the time of signing the informed consent.
Diagnosis of multiple myeloma with a requirement for treatment as documented per international myeloma working group (IMWG) criteria.
Must have at least one aspect of measurable disease, defined as one of the following:
Urine M-protein excretion >=200 mg/24 hours (>=0.2 gram [g]/24 hours), or
Serum M-protein concentration >=0.5 grams per deciliter (g/dL) (>=5.0 gram per liter [g/L]), or
Serum free light chain (FLC) assay: involved FLC level >=10 milligrams per deciliter (mg/dL) (>=100 milligram per liter [mg/L]) and an abnormal serum free light chain ratio (<0.26 or >1.65).
Not a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to presence of significant comorbid condition(s), such as cardiac, pulmonary or other major organ dysfunction that are likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation, as judged by the investigator.
Eastern cooperative oncology group (ECOG) status of 0-2
Adequate organ system functions as defined by the laboratory assessments listed as following: Absolute neutrophil count (ANC) >=1.5 x 10^9/L; Hemoglobin >=8.0 g/dL; Platelets >=75 x 10^9/L; Total bilirubin <=1.5 x upper limit of normal (ULN); (Isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%); Alanine aminotransferase (ALT) <=2.5 x ULN; eGFR >=30 mL/minute/1.73 meter^2; Urine Dipstick for protein OR Albumin/creatinine ratio (from spot urine)- Negative/trace (if >=1 plus only eligible if confirmed <=500 mg/gram (56 mg/millimoles [mmol]) by albumin/creatinine ratio (spot urine from first void); Left Ventricular Ejection Fraction (LVEF) by echocardiogram (ECHO) of >=35% participants with low LVEF (per institutional standards), consider referring to cardiology per local standards of care.
Sex and Contraception/Barrier Requirements (Female):
Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
Is NOT a woman of childbearing potential (WOCBP) or Due to lenalidomide being a thalidomide analogue with risk for embryofetal toxicity and prescribed under a pregnancy prevention/controlled distribution program, and bortezomib having the potential to cause fetal harm, WOCBP participants will be eligible if they commit to either: abstain continuously from heterosexual sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR to use birth control as follows: Two methods of reliable birth control (one method that is highly effective and one additional effective (barrier) method), beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of lenalidomide treatment. Thereafter, WOCBP participants must use one method of reliable birth control that is highly effective for a further 3 months following discontinuation of belantamab mafodotin, or a further 6 months following discontinuation of bortezomib, whichever is longer. WOCBP must also agree not to donate eggs (ova, oocytes) for the purpose of reproduction during treatment, during dose interruptions and for 28-days following the last dose of lenalidomide, 4 months following discontinuation of belantamab mafodotin treatment or 7-months following the last dose of bortezomib, whichever is longer. Two negative pregnancy tests must be obtained prior to initiating therapy. The first test should be performed within 10-14 days and the second test within 24 hours prior to prescribing the start of lenalidomide therapy.

The participant should not receive lenalidomide until the investigator has verified that the results of these pregnancy tests are negative. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.

Sex and Contraception/Barrier Requirements (Male):
Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Male participants are eligible to participate if they agree to the following from the time of first dose of study treatment until 28-days after the last dose of lenalidomide, 4-months after the last dose of bortezomib, or 6 months after the last dose of belantamab mafodotin, whichever is longer, to allow for clearance of any altered sperm: Refrain from donating sperm - Plus either: - Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below: Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse with a WOCBP. Male participants should also use a condom when having sexual intercourse with pregnant females.
Capable of giving signed informed consent.

Exclusion Criteria:

Smoldering multiple myeloma (SMM).
Prior systemic therapy for multiple myeloma, or SMM. NOTE: An emergency course of steroids (defined as no greater than 40 mg of dexamethasone, or equivalent per day for a maximum of 4 days (that is, a total of 160 mg) is permitted. NOTE: Focal palliative radiation is permitted prior to enrollment, provided that it occurred at least 2 weeks prior to the first dose of study drug, that the participant has recovered from radiation-related toxicities, and that the participant did not require corticosteroids for radiation-induced adverse events.
Participant is eligible for high dose chemotherapy with ASCT, as determined by a frailty score of 0 as assessed by the IMWG frailty index.
Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the national cancer institute (NCI)-common terminology criteria for adverse events (CTCAE) Version 5.
Major surgery within 4 weeks prior to the first dose of study drug.
Presence of active renal condition (infection, requirement for dialysis or any other significant condition that could affect participant's safety). Participants with isolated proteinuria resulting from multiple myeloma (MM) are eligible, provided they fulfil criteria.
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
Evidence of active mucosal or internal bleeding uncontrolled by local therapy and not explained by reversible coagulopathy.
Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease as per the Investigator's assessment).
Participants with previous or concurrent malignancies other than multiple myeloma are excluded. Exceptions are surgically treated cervical carcinoma in situ, or any other malignancy that has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease. Note: Participants with curatively treated non-melanoma skin cancer are allowed without a 2-year restriction.
Evidence of cardiovascular risk including any of following: Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities including second degree (Mobitz Type II) or third degree atrioventricular (AV) block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening.; Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; Uncontrolled hypertension.
Active infection requiring treatment.
Known human immunodeficiency virus (HIV) infection.
Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb), at Screening or within 3 months prior to first dose of study treatment.
Positive hepatitis C antibody test result.
Current corneal epithelial disease except for mild punctate keratopathy. Note: Participants with mild punctate keratopathy are allowed.
Intolerance or contraindications to anti-viral prophylaxis.
Unable to tolerate antithrombotic prophylaxis.
AL amyloidosis (light chain amyloidosis), active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes (POEMS) syndrome or active plasma cell leukemia at the time of screening.
Exhibiting clinical signs of or has a known history of meningeal or central nervous system involvement by multiple myeloma.
Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
Use of an investigational drug within 14 days or five half-lives (whichever is longer) preceding the first dose of study drug.
Plasmapheresis within 7 days prior to the first dose of study drug.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Finalidade Principal: Tratamento
Alocação: Randomizado
Modelo Intervencional: Atribuição sequencial
Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço Grupo de Participantes / Braço Um grupo ou subgrupo de participantes em um estudo clínico que recebe uma intervenção/tratamento específico, ou nenhuma intervenção, de acordo com o protocolo do estudo.	Intervenção / Tratamento Intervenção / Tratamento Um processo ou ação que é o foco de um estudo clínico. As intervenções incluem medicamentos, dispositivos médicos, procedimentos, vacinas e outros produtos em fase de investigação ou já disponíveis. As intervenções também podem incluir abordagens não invasivas, como educação ou modificação da dieta e exercícios.
Experimental: Cohort 1: belantamab mafodotin 1.9 mg/kg Q3/4W + VRd/Rd Participants will receive 1.9 milligram /kilogram (mg/kg) Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.	Medicamento: Belantamab mafodotin Selected doses of belantamab mafodotin will be administered as intravenous infusion. Medicamento: Bortezomib Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8. Medicamento: Lenalidomide Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function. Medicamento: Dexamethasone Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
Experimental: Cohort 2: belantamab mafodotin 1.4 mg/kg Q6/8W + VRd/Rd Participants will receive 1.4 mg/kg Q6W dose of belantamab mafodotin on Day 1 of every other cycle for the first 8 cycles in combination with VRd and Q8W dose in combination with Rd from cycle 9 onwards.	Medicamento: Belantamab mafodotin Selected doses of belantamab mafodotin will be administered as intravenous infusion. Medicamento: Bortezomib Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8. Medicamento: Lenalidomide Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function. Medicamento: Dexamethasone Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
Experimental: Cohort 3: belantamab mafodotin 1.9 mg/kg Q6/8W + VRd/Rd Participants will receive 1.9 mg/kg Q6W dose of belantamab mafodotin on Day 1 of every other cycle for the first 8 cycles in combination with VRd and Q8W dose in combination with Rd from cycle 9 onwards.	Medicamento: Belantamab mafodotin Selected doses of belantamab mafodotin will be administered as intravenous infusion. Medicamento: Bortezomib Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8. Medicamento: Lenalidomide Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function. Medicamento: Dexamethasone Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
Experimental: Cohort 4: belantamab mafodotin 1.0 mg/kg Q3/4W + VRd/Rd Participants will receive 1.0 mg/kg Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.	Medicamento: Belantamab mafodotin Selected doses of belantamab mafodotin will be administered as intravenous infusion. Medicamento: Bortezomib Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8. Medicamento: Lenalidomide Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function. Medicamento: Dexamethasone Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
Experimental: Cohort 5: belantamab mafodotin 1.4 mg/kg Q3/4W + VRd/Rd Participants will receive 1.4 mg/kg Q3W dose of belantamab mafodotin on Day 1 of every cycle for the first 8 cycles in combination with VRd and Q4W dose in combination with Rd from cycle 9 onwards.	Medicamento: Belantamab mafodotin Selected doses of belantamab mafodotin will be administered as intravenous infusion. Medicamento: Bortezomib Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8. Medicamento: Lenalidomide Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function. Medicamento: Dexamethasone Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
Experimental: Cohort 6: belantamab mafodotin 1.4mg/kg cycle 1, 1.0 mg/kg Q9/12W Cycle 4+VRd/Rd Based on emerging data from Cohort 2-5, participants will receive 1.4 mg/kg dose of belantamab mafodotin on Day 1 of cycle 1, followed by 1.0 mg/kg dose on Day 1 of every third cycle from cycle 4 onwards, in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.	Medicamento: Belantamab mafodotin Selected doses of belantamab mafodotin will be administered as intravenous infusion. Medicamento: Bortezomib Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8. Medicamento: Lenalidomide Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function. Medicamento: Dexamethasone Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
Experimental: Cohort 7: belantamab mafodotin 1.9 mg/kg Cycle 1, 1.4 mg/kg Q9/12W Cycle 4+VRd/Rd Based on emerging data from Cohort 2-5, participants will receive 1.9 mg/kg dose of belantamab mafodotin of cycle 1, followed by 1.4 mg/kg on Day 1 of every third cycle from cycle 4 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.	Medicamento: Belantamab mafodotin Selected doses of belantamab mafodotin will be administered as intravenous infusion. Medicamento: Bortezomib Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8. Medicamento: Lenalidomide Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function. Medicamento: Dexamethasone Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
Experimental: Cohort 8a : belantamab mafodotin 1.9 mg/kg Cycle 1,4; 1.4 mg/kg Q9/12W from Cycle 7 +VRd/Rd Based on emerging data from Cohort 6-7, participants will receive 1.9 mg/kg dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 4, followed by 1.4 mg/kg on Day 1 of every third cycle from cycle 7 onwards, in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.	Medicamento: Belantamab mafodotin Selected doses of belantamab mafodotin will be administered as intravenous infusion. Medicamento: Bortezomib Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8. Medicamento: Lenalidomide Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function. Medicamento: Dexamethasone Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
Experimental: Cohort 8b: belantamab mafodotin 1.4 mg/kg Cycle 1,3; 1.0 mg/kg Q9/12W from Cycle 6 +VRd/Rd Based on emerging data from Cohort 6-7, participants will receive 1.4 mg/kg IV dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 3, then 1.0 mg/kg on Day 1 of every third cycle from cycle 6 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.	Medicamento: Belantamab mafodotin Selected doses of belantamab mafodotin will be administered as intravenous infusion. Medicamento: Bortezomib Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8. Medicamento: Lenalidomide Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function. Medicamento: Dexamethasone Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
Experimental: Cohort 8c: belantamab mafodotin 1.0 mg/kg Cycle 1,5;1.0 mg/kg Q9/12W from Cycle 9 +VRd/Rd Based on emerging data from Cohort 6-7, participants will receive 1.0 mg/kg IV dose of belantamab mafodotin on Day 1 of cycle 1 and cycle 5, then 1.0 mg/kg on day 1 of every third cycle from cycle 9 in combination with VRd for the first 8 cycles and in combination with Rd from cycle 9 onwards.	Medicamento: Belantamab mafodotin Selected doses of belantamab mafodotin will be administered as intravenous infusion. Medicamento: Bortezomib Bortezomib will be administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8. Medicamento: Lenalidomide Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function. Medicamento: Dexamethasone Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Number of Participants With Dose-limiting Toxicities (DLTs) of Belantamab Mafodotin Prazo: Up to 63 days	Criteria for DLT included hematologic indicators including Grade(G) 3-5 febrile neutropenia, G4 neutropenia >7 days, G3 or greater thrombocytopenia accompanied by clinically significant bleeding; non-hematologic criteria, including Any G3/4 non-hematologic toxicity, G5 non hematologic toxicity, G3 or greater corneal toxicity; Liver toxicity meeting prespecified GSK liver stopping criteria. Severity was graded using National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.	Up to 63 days
Number of Participants With Adverse Events (AEs) Prazo: Up to approximately 284 weeks	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were to be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.	Up to approximately 284 weeks

Medidas de resultados secundários

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

GlaxoSmithKline

Investigadores

Diretor de estudo: GSK Clinical Trials, GlaxoSmithKline

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

18 de dezembro de 2019

Conclusão Primária (Real)

2 de junho de 2025

Conclusão do estudo (Estimado)

10 de março de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

13 de setembro de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de setembro de 2019

Primeira postagem (Real)

16 de setembro de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

209664
2023-507060-39 (Identificador de registro: CTIS)
2023 (Concessão/Contrato do NIH dos EUA)
2019 (Concessão/Contrato do NIH dos EUA)
2019-003047-30 (Identificador de registro: EudraCT (EU))
2023-507060-39-00 (Identificador de registro: CTIS (EU))

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

IPD for this study will be made available via the Clinical Study Data Request site.

Prazo de Compartilhamento de IPD

IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study

Critérios de acesso de compartilhamento IPD

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Tipo de informação de suporte de compartilhamento de IPD

PROTOCOLO DE ESTUDO
SEIVA
CIF
CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Medida de resultado	Descrição da medida	Prazo
Lenalidomide Relative Dose Intensity (RDI) After Treatment With Belantamab Mafodotin in Combination With VRd Prazo: Up to 168 days	Relative Dose Intensity (RDI) is defined as the percentage of the amount of a drug actually delivered (actual dose intensity [DI]) relative to the amount planned (planned DI).	Up to 168 days
Bortezomib RDI After Treatment With Belantamab Mafodotin in Combination With VRd Prazo: Up to 168 days	Relative Dose Intensity (RDI) is defined as the percentage of the amount of a drug actually delivered (actual dose intensity [DI]) relative to the amount planned (planned DI).	Up to 168 days
Cumulative Administered Dose of Belantamab Mafodotin After Treatment in Combination With VRd Prazo: Up to 84 days	Cumulative Dose is sum of the actual dose administered during each infusion for a participant.	Up to 84 days
Area Under the Concentration Time Curve From 0 to 504 Hours [AUC (0 - 504 Hours)] of Belantamab Mafodotin Prazo: Day 1 Cycle 1 Pre-Dose, End of Infusion (EOI); Anytime between Day 8 and Day 15 after Start of Infusion (SOI); Cycle 2 Day 1 Pre-Dose (up to Day 22 or at the end of the Cycle 1 dosing period)	Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin. The last PK assessment used to derive AUC0-504h was intended to be collected approximately 504 hours (21 days) after the start of the first infusion. Depending on the dosing schedule, this assessment occurred either at the Day 22 visit (±3 days) for participants in the Q6/8W and Q9/12W cohorts or at the Cycle 2 Day 1 pre-dose visit for participants in the Q3W cohorts. Therefore, samples collected at Day 22 or Cycle 2 Day 1 predose represent the protocol-defined PK assessment performed at approximately 504 hours after Dose 1.	Day 1 Cycle 1 Pre-Dose, End of Infusion (EOI); Anytime between Day 8 and Day 15 after Start of Infusion (SOI); Cycle 2 Day 1 Pre-Dose (up to Day 22 or at the end of the Cycle 1 dosing period)
Maximum Plasma Concentration (Cmax) of Belantamab Mafodotin Prazo: Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)	Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin.	Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)
Time to Reach Cmax (Tmax) of Belantamab Mafodotin Prazo: Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)	Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin.	Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)
Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) of Belantamab Mafodotin Prazo: Pre-dose at Day 1 of Cycle 1, 2, 3, 4, 5, 7, 10, 13, 14, 15, 16, 17, 23, 24, 27, 28, 29, 30, 31, 34, 36, 37, 41, 43, 49	Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin. C-trough were measured prior to the next dose for each cycle.	Pre-dose at Day 1 of Cycle 1, 2, 3, 4, 5, 7, 10, 13, 14, 15, 16, 17, 23, 24, 27, 28, 29, 30, 31, 34, 36, 37, 41, 43, 49
Observed Plasma Concentration at the End of Infusion (C-EOI) of Belantamab Mafodotin Prazo: End of infusion at Day 1 on C1, C2, C3, C4, C5, C6, C7, C8, C9, C10, C11, C12, C13, C14, C15, C16, C17, C18, C19, C20, C21, C22, C24, C25, C26, C27 (up to approximately 81 weeks)	Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin.	End of infusion at Day 1 on C1, C2, C3, C4, C5, C6, C7, C8, C9, C10, C11, C12, C13, C14, C15, C16, C17, C18, C19, C20, C21, C22, C24, C25, C26, C27 (up to approximately 81 weeks)
Time of Last Observed Quantifiable Concentration (Tlast) of Belantamab Mafodotin Prazo: Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI); Cycle 2 Day 1 Pre-Dose (up to Day 22 or at the end of the Cycle 1 dosing period)	Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin. The last PK assessment used to derive Tlast was intended to be collected approximately 504 hours (21 days) after the start of the first infusion. Depending on the dosing schedule, this assessment occurred either at the Day 22 visit (±3 days) for participants in the Q6/8W and Q9/12W cohorts or at the Cycle 2 Day 1 pre-dose visit for participants in the Q3W cohorts. Therefore, samples collected at Day 22 or Cycle 2 Day 1 predose represent the protocol-defined PK assessment performed at approximately 504 hours after Dose 1.	Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI); Cycle 2 Day 1 Pre-Dose (up to Day 22 or at the end of the Cycle 1 dosing period)
Clearance of Belantamab Mafodotin Prazo: Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)	Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin.	Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)
Volume of Distribution at Steady State (Vss) of Belantamab Mafodotin Prazo: Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)	Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin.	Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)
Apparent Terminal Half Life (t1/2) of Belantamab Mafodotin Prazo: Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)	Blood Samples were collected for Pharmacokinetic analysis of belantamab mafodotin.	Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)
AUC (0 - 504 Hour) of Cys-mcMMAF Prazo: Day 1 Cycle 1 Pre-Dose, End of Infusion (EOI); Anytime between Day 8 and Day 15 after Start of Infusion (SOI); Cycle 2 Day 1 Pre-Dose (up to Day 22 or at the end of the Cycle 1 dosing period)	Blood Samples were collected for Pharmacokinetic analysis of cys-mcMMAF. The last PK assessment used to derive AUC0-504h was intended to be collected approximately 504 hours (21 days) after the start of the first infusion. Depending on the dosing schedule, this assessment occurred either at the Day 22 visit (±3 days) for participants in the Q6/8W and Q9/12W cohorts or at the Cycle 2 Day 1 pre-dose visit for participants in the Q3W cohorts. Therefore, samples collected at Day 22 or Cycle 2 Day 1 predose represent the protocol-defined PK assessment performed at approximately 504 hours after Dose 1.	Day 1 Cycle 1 Pre-Dose, End of Infusion (EOI); Anytime between Day 8 and Day 15 after Start of Infusion (SOI); Cycle 2 Day 1 Pre-Dose (up to Day 22 or at the end of the Cycle 1 dosing period)
Cmax of Cys-mcMMAF Prazo: D1 C1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72h; D8-15 post Start of Infusion(SOI); 22d post-SOI; PD & EOI at D1 of C2-7,10,14-17,19,22,26; PD at D1 of C13,18,21,23,24,27-31,34,36,37,39,41,43,46,49; End of Treatment(EOT) (~C52, up to ~234weeks)	Blood Samples were collected for Pharmacokinetic analysis of cys-mcMMAF.	D1 C1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72h; D8-15 post Start of Infusion(SOI); 22d post-SOI; PD & EOI at D1 of C2-7,10,14-17,19,22,26; PD at D1 of C13,18,21,23,24,27-31,34,36,37,39,41,43,46,49; End of Treatment(EOT) (~C52, up to ~234weeks)
Time to Reach Cmax (Tmax) of Cys-mcMMAF Prazo: Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)	Blood Samples were collected for Pharmacokinetic analysis of cys-mcMMAF.	Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI);22 days post-SOI;PD&EOI at D1 of C2-7,C10,C14-17; PD at D1 of C13,C23,C24, C27-29, C34, C39, C46; End of Treatment(~C52,up to ~234weeks)
Observed Plasma C-EOI of Cys-mcMMAF Prazo: End of infusion at Day 1 on C1, C2, C3, C4, C5, C6, C7, C8, C9, C10, C11, C12, C13, C14, C15, C16, C17, C18, C19, C20, C21, C22, C24, C25, C26, C27 (up to approximately 81 weeks)	Blood Samples were collected for Pharmacokinetic analysis of cys-mcMMAF.	End of infusion at Day 1 on C1, C2, C3, C4, C5, C6, C7, C8, C9, C10, C11, C12, C13, C14, C15, C16, C17, C18, C19, C20, C21, C22, C24, C25, C26, C27 (up to approximately 81 weeks)
Tlast of Cys-mcMMAF Prazo: Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI)	Blood Samples were collected for Pharmacokinetic analysis of cys-mcMMAF.	Day(D)1 Cycle(C)1 Pre-Dose(PD), End of Infusion(EOI), 2, 24, 72 Hours(h);Anytime D8-15 after Start of Infusion(SOI)
Number of Participants With Positive Post-baseline Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin Prazo: Up to approximately 234 weeks	Serum samples were collected for the analysis of ADAs of anti-belantamab mafodotin.	Up to approximately 234 weeks
Titers of ADAs Against Belantamab Mafodotin Prazo: Up to approximately 234 weeks	Serum Samples were collected for the analysis of ADAs of anti-belantamab mafodotin.	Up to approximately 234 weeks
Overall Response Rate (ORR) Prazo: Up to approximately 284 weeks	ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response [VGPR], complete response [CR] and stringent complete response [sCR]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR: negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR: CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hour (h); PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg/24 h.	Up to approximately 284 weeks
Complete Response Rate (CRR) Prazo: Up to approximately 284 weeks	CRR is defined as the percentage of participants with a confirmed complete response (CR) or better (i.e. CR and stringent complete response [sCR]), according to the IMWG Response Criteria. CR: negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR: CR as above PLUS normal serum FLC assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.	Up to approximately 284 weeks
Percentage of Participants With Confirmed VGPR or Better Prazo: Up to approximately 284 weeks	VGPR or better (i.e. VGPR, CR, sCR) is defined as - VGPR: serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 h , CR: negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR: CR as above PLUS normal serum FLC assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.	Up to approximately 284 weeks

Estudo de Belantamab Mafodotin Plus Standard of Care (SoC) em Mieloma Múltiplo Recentemente Diagnosticado (DREAMM 9)

Um estudo de avaliação de fase 1, randomizado, de dose e esquema para investigar a segurança, farmacocinética, farmacodinâmica e atividade clínica de Belantamab Mafodotin administrado em combinação com tratamento padrão em participantes com mieloma múltiplo recém-diagnosticado

Visão geral do estudo

Status

Condições

Intervenção / Tratamento

Tipo de estudo

Inscrição (Real)

Estágio

Acesso expandido

Contactos e Locais

Locais de estudo

Critérios de participação

Critérios de elegibilidade

Idades elegíveis para estudo

Aceita Voluntários Saudáveis

Gêneros Elegíveis para o Estudo

Descrição

Plano de estudo

Como o estudo é projetado?

Detalhes do projeto

Número de braços

Armas e Intervenções

Grupo de Participantes / Braço

Intervenção / Tratamento

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado

Descrição da medida

Prazo

Medidas de resultados secundários

Medida de resultado

Descrição da medida

Prazo

Colaboradores e Investigadores

Patrocinador

Investigadores

Datas de registro do estudo

Datas Principais do Estudo

Início do estudo (Real)

Conclusão Primária (Real)

Conclusão do estudo (Estimado)

Datas de inscrição no estudo

Enviado pela primeira vez

Enviado pela primeira vez que atendeu aos critérios de CQ

Primeira postagem (Real)

Atualizações de registro de estudo

Última Atualização Postada (Real)

Última atualização enviada que atendeu aos critérios de controle de qualidade

Última verificação

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Descrição do plano IPD

Prazo de Compartilhamento de IPD

Critérios de acesso de compartilhamento IPD

Tipo de informação de suporte de compartilhamento de IPD

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Estuda um produto de dispositivo regulamentado pela FDA dos EUA