Hemotrial Un proyecto de SEHH

Ensayo clínico

Estudio abierto internacional multicéntrico de vorinostat (MK-0683) en combinación con bortezomib en pacientes con mieloma múltiple recidivante y resistente al tratamientoAn International, Multicenter, Open-Label Study of Vorinostat (MK-0683) in Combination with Bortezomib in Patients with Relapsed and Refractory Multiple Myeloma

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Estudio abierto internacional multicéntrico de vorinostat (MK-0683) en combinación con bortezomib en pacientes con mieloma múltiple recidivante y resistente al tratamientoAn International, Multicenter, Open-Label Study of Vorinostat (MK-0683) in Combination with Bortezomib in Patients with Relapsed and Refractory Multiple Myeloma


Resumen

2017-03-15 04:08:47
2008-003753-33
095
Estudio abierto internacional multicéntrico de vorinostat (MK-0683) en combinación con bortezomib en pacientes con mieloma múltiple recidivante y resistente al tratamientoAn International, Multicenter, Open-Label Study of Vorinostat (MK-0683) in Combination with Bortezomib in Patients with Relapsed and Refractory Multiple Myeloma
095

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Merck & Co., Inc. United States

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test bortezomib injection
GALEN Pharma GmbH Vorinostat Capsules
MK-0683 Capsule*
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

100

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 2:
Comparator Dexamethasone 4 mg GALEN
bortezomib injection
Injection*
Intravenous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

3.5

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 3:
Comparator
Dexamethasone 4 mg GALEN
Capsule*
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

4

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General



Mielomas

Mieloma múltiplemultiple myeloma


To define the objective response rate associated with the administration of vorinostat in combination with bortezomib to patients with relapsed or refractory multiple myeloma after at least 2 prior treatment regimens.

To assess the tolerability and adverse experience profile of vorinostat administered in combination with bortezomib.To assess the time to disease progression associated with the administration of vorinostat in combination with bortezomib.To evaluate the progression-free survival associated with the administration of vorinostat in combination with bortezomib.To evaluate overall survival associated with the administration of vorinostat in combination with bortezomib.

No


1. Patient has an established diagnosis of multiple myeloma based on myeloma diagnostic criteria.2. Patient has relapsed or refractory multiple myeloma after at least 2 prior treatment regimens as per the EBMT response criteria and meets both of the following conditions:• Patient's myeloma was refractory to bortezomib; defined as no response on prior bortezomib-containing regimens or progression on or within 60 days of a bortezomib-containing regimen. • Patient was exposed to an IMiD (thalidomide or lenalidomide); defined as patients who received at least 1 dose of an IMiD and were intolerant to or whose myeloma relapsed or was refractory to IMiD containing regimen.3. Patient has received at least 2 prior (standard or experimental) anti-myeloma regimens.

1. Patient has had any prior allogeneic bone marrow transplant (patient with prior autologous transplant is eligible).2. Patient plans to undergo any type of bone marrow transplantation (allogeneic, or autologous) within 4 weeks after initiating study therapy.3. Patient had prior treatment with vorinostat or other HDAC inhibitors (e.g., depsipeptide, MS-275, LAQ-824, PXD-101, LBH589, MGCD0103, CRA024781, etc.). Patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid, as anti-tumor therapy should not be enrolled in this study. Patients who have received such compounds for other indications, e.g. valproic acid for epilepsy, may enroll after a 30-day washout period.4. Patient was unable to tolerate prior treatment with bortezomib.

The primary endpoint for this study is response rate, defined as the percentage of subjects who achieve partial response or better during the study.

Fase II
  DISEÑO DEL ENSAYO:

No
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT
  COMPARADOR DEL ENSAYO CONTROLADO:

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

Si

Centros participantes:


Si
Information no disponible en EudraCT
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO:


18
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO EN ESPAÑA:


  POBLACIÓN DE PACIENTES EN EL ESTUDIO:
  Población de pacientes: 1

Rango de edad:


0
1

1

Sexo:


1
1

Número planeado de pacientes a incluir:


9

Para estudios internacionales:


72
142

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


EC Finalizado



EC Finalizado