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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01453101
Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma (Flu-Mel-Vel)
A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma Using a Conditioning Regimen of Fludarabine, Melphalan, and Bortezomib
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Multiple myeloma is the second most prevalent blood cancer (10%) after non-hodgkin's lymphoma. It represents approximately 1% of all cancers and 2% of all cancer deaths. Although the peak age of onset of multiple myeloma is 70 years of age, recent statistics indicate both increasing incidence and earlier age of onset.
The historical control 2-year progression-free survival (PFS) is assumed to be 35%. The proposed therapy of fludarabine, melphalan and bortezomib is expected to improve the PFS by 20%.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- John Theurer Cancer Center at Hackensack University Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Diagnosis of multiple myeloma
- Have a suitable related or unrelated donor
- Age ≥18 but <70 yrs
- KPS of ≥70%
- Recovery from complications of previous therapies
Exclusion Criteria:
- Diagnosis other than multiple myeloma
- Chemotherapy or radiotherapy within 21 days of initiating treatment in this study
- Prior dose-intense therapy requiring HSC support within 56 days of initiating treatment in this study
- Uncontrolled bacterial, viral, fungal or parasitic infections
- Uncontrolled CNS metastases
- Known amyloid deposition in heart
- Organ dysfunction
- LVEF <40% or cardiac failure not responsive to therapy
- FVC, FEV1, or DLCO <50% of predicted and/or receiving supplementary continuous oxygen
- Evidence of hepatic synthetic dysfunction, or total bilirubin >2x or AST >3x ULN
- Measured creatinine clearance <20 ml/min
- Sensory peripheral neuropathy grade 4 within 14 days of enrollment
- Karnofsky score <70% unless a result of bone disease directly caused by myeloma
- Life expectancy limited by another co-morbid illness
- Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
- Female subject is pregnant or breast-feeding (women) or unwilling to use acceptable birth control methods (men or women) for twelve months after treatment. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Documented hypersensitivity to fludarabine or melphalan or to bortezomib, boron or mannitol or any components of the formulation
- Patients unable or unwilling to provide consent
- Patient has a sustained platelet count of <30 x 10 9/L within 14 days before enrollment
- Patient has a sustained absolute neutrophil count of <1.0 x10 9/L within 14 days before enrollment
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant
- Patient has received other investigational drugs with 14 days before enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Outro: Fludarabine, Melphalan, Bortezomib
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Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Progression Free Survival
Prazo: Subjects will be followed for progression-free survival for at least 36 months
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The main primary endpoint of this study is two-year progression free survival.
Patients are considered a failure with respect to PFS if they die or experience disease progression or relapse.
The time to this event is the time from transplantation to relapse/progression, initiation of non-protocol anti-myeloma therapy, or death from any cause.
Subjects alive without confirmed disease progression will be censored at the time of last disease evaluation.
Deaths without progression are treated as failures no matter when they occur.
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Subjects will be followed for progression-free survival for at least 36 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Overall Survival (OS)
Prazo: Up to 3 years
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Overall survival (OS): Defined as time from the first dose of administration to death from any cause
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Up to 3 years
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Overall Response Rate
Prazo: Up to 3 years
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Overall response rate: Defined as the composite endpoint of response to treatment which includes Complete Response (CR), Partial Response (PR), stable disease (SD) as defined in International Response Criteria. International Myeloma Working Group Response Criteria for Multiple Myeloma: CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow PR: > 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or to < 200 mg/24 h SD: Not meeting criteria for CR, VGPR, PR, or progressive disease |
Up to 3 years
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
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
- Doenças cardiovasculares
- Doenças Vasculares
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Neoplasias
- Distúrbios Linfoproliferativos
- Distúrbios imunoproliferativos
- Doenças Hematológicas
- Distúrbios hemorrágicos
- Distúrbios hemostáticos
- Paraproteinemias
- Distúrbios das Proteínas Sanguíneas
- Mieloma múltiplo
- Neoplasias de Células Plasmáticas
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Antimetabólitos, Antineoplásicos
- Antimetabólitos
- Agentes Antineoplásicos
- Agentes imunossupressores
- Fatores imunológicos
- Agentes Antineoplásicos Alquilantes
- Agentes Alquilantes
- Agonistas Mieloablativos
- Melfalano
- Bortezomibe
- Fludarabina
- Fosfato de fludarabina
Outros números de identificação do estudo
- PRO1261
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