Hemotrial Un proyecto de SEHH

Ensayo clínico

Estudio internacional, multicéntrico, aleatorizado, doble ciego de Vorinostat (MK-0683) o placebo en combinación con bortezomib en pacientes con mieloma multipleAn International, Multicenter, Randomized, Double-Blind Study of Vorinostat (MK-0683) or Placebo in Combination with Bortezomib in Patients with Multiple Myeloma

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Resumen

2017-03-15 04:08:44
2008-003752-30
088
Estudio internacional, multicéntrico, aleatorizado, doble ciego de Vorinostat (MK-0683) o placebo en combinación con bortezomib en pacientes con mieloma multipleAn International, Multicenter, Randomized, Double-Blind Study of Vorinostat (MK-0683) or Placebo in Combination with Bortezomib in Patients with Multiple Myeloma
088

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

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
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
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
  INFORMACIÓN DE PLACEBOS USADOS:
  PLACEBO 1:

Si
Capsule*

Oral use

Información General

Mielomas

mieloma múltiplemultiple myeloma

To determine the duration of PFS in patients with multiple myeloma, after at least 1 prior treatment regimen, treated with bortezomib and vorinostat compared to patients treated with bortezomib and placebo.

•To assess the tolerability of vorinostat administered in combination with bortezomib•To determine the OS of patients with multiple myeloma, after at least 1 prior treatment regimen, treated with bortezomib and vorinostat compared to patients treated with bortezomib and placebo•To determine the TTP in patients with multiple myeloma, after at least 1 prior treatment regimen, treated with bortezomib and vorinostat compared to patients treated with bortezomib and placebo •To determine the objective RR of patients with multiple myeloma, after at least 1 prior treatment regimen, treated with bortezomib and vorinostat compared to patients treated with bortezomib and placebo using the European Blood and Marrow Transplant Group (EBMT) Criteria •To measure pharmacokinetic parameters and conduct pharmacokinetic/ pharmacodynamic modeling to explore exposure/response relationships in patients treated with bortezomib together with vorinostat compared to bortezomib together with placebo

No


1. Patient has an established diagnosis of multiple myeloma based on the myeloma diagnostic criteria. 2. Patient has received at least 1 but not more than 3 prior anti-myeloma regimens and has progressive disease after the most recent treatment regimen as per the European Blood and Marrow Transplantation Group (EBMT) Criteria. 3. Patient who received prior bortezomib-containing regimen and meets the following criteria is also eligible: While on prior bortezomib-based therapy, the patient must have achieved a minimal response (MR), partial response (PR), or complete response (CR). Patient was not considered bortezomib refractory.4. Patient has measurable disease, defined as any quantifiable serum M-protein value and, where applicable, urine light chain of ?200 mg/24 hours.5. Patient has adequate organ function.

1. Patient has had any prior allogeneic bone marrow transplant (patient with prior autologous transplant are eligible).2. Patient plans to undergo any type of bone marrow transplantation (allogeneic, or autologous) within 4 weeks after initiating study therapy.3. Patient has had prior treatment with vorinostat or 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 is receiving corticosteroid therapy (>10 mg of prednisone or equivalent). However, use of ?10 mg of prednisone or equivalent is allowed for reasons other than myeloma.

The primary efficacy endpoint for this study is PFS, the time from randomization to disease progression or death due to any cause.

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

No
No

Si
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
Si

No
No

Si

Centros participantes:

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


30
  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:

30

Para estudios internacionales:

185
750

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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