Hemotrial Un proyecto de SEHH

Ensayo clínico

A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis Ensayo fase III randomizado, abierto, multicéntrico, de Melfalán y Dexamentasona (MDex) versus Bortezomib, Melfalán y Dexametasona (BMDex) para pacientes con Amiloidosis Primaria sistémica (AL) de nuevo diagnóstico

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A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis Ensayo fase III randomizado, abierto, multicéntrico, de Melfalán y Dexamentasona (MDex) versus Bortezomib, Melfalán y Dexametasona (BMDex) para pacientes con Amiloidosis Primaria sistémica (AL) de nuevo diagnóstico


Resumen

2017-03-15 04:18:10
2010-022395-31
AC-004-EU
A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis Ensayo fase III randomizado, abierto, multicéntrico, de Melfalán y Dexamentasona (MDex) versus Bortezomib, Melfalán y Dexametasona (BMDex) para pacientes con Amiloidosis Primaria sistémica (AL) de nuevo diagnóstico
AC-004-EU

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
E.M.N. - EUROPEAN MYELOMA NETWORK European Myeloma Network Pieter Sonneveld Denmark

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test VELCADE
Janssen Cilag SpA Dexamethasone
Dexametasone Powder and solvent for solution for injection
Intravenous use

Detalles del Fármaco (Principio Activo):

26866138 VELCADE

Concentración del fármaco:

mg/ml milligram equal

1

Contenido del fármaco


Si
No

No
No

No
No

No
No

No
No

No
No

No
  FÁRMACO 2:
Test Dexamethasone
PL 0033/0153 Melphalan
melphalan Oral drops, solution
Oral use

Detalles del Fármaco (Principio Activo):

ATC code S01 - DEXAMETHASONE

Concentración del fármaco:

mg milligram(s) equal

1

Contenido del fármaco


Si
No

No
No

No
No

No
No

No
No

No
No

No
  FÁRMACO 3:
Test melphalan
EU/1/08/443/001 Dexamethasone
Film-coated tablet
Oral use

Detalles del Fármaco (Principio Activo):

MELPHALAN DEXAMETHASONE

Concentración del fármaco:

mg milligram(s) equal

7.4

Contenido del fármaco


Si
No

No
No

No
No

No
No

No
No

No
No

No
  FÁRMACO 4:
Comparator betamethasone
PL. 17507/0053 Melphalan
Oral drops, solution
Oral use

Detalles del Fármaco (Principio Activo):

CC-4047

Concentración del fármaco:

U/ml unit(s)/mi equal

7

Contenido del fármaco


Si
No

No
No

No
No

No
No

No
No

No
No

No
  FÁRMACO 5:
Comparator melphalan
EU/1/08/443/001
Film-coated tablet
Oral use

Detalles del Fármaco (Principio Activo):

MLN9708

Concentración del fármaco:

mg/kg milligram equal

7.4

Contenido del fármaco


Si
No

No
No

No
No

No
No

No
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General



Mielomas

AL Amyloidosis Amiloidosis


To compare the hematologic response after 3 cycles of therapy

1. Complete hematologic response rate after 3 cycles and after completion of therapy; 2. Hematologic response rate at completion of therapy; 3. Organ response rates at 3, 6, 9 and 12 months; 4. Treatment-related mortality; 5. Toxicity; 6. Overall and progression-free survival; 7. Time to hematologic and organ response; 8. Quality of life.

No


1. Histologic diagnosis of amyloidosis. 2. Genetic testing must be negative for transthyretin mutations associated with hereditary amyloidosis or immunohistochemistry of amyloid deposits must provide clear evidence of K or ? light chains in those who present with peripheral neuropathy or heart as the dominant organ involvement. 3. Not eligible for ASCT with melphalan 200 mg/m2 . Patients who are eligible for SCT with melphalan 200 mg/m2 but decline the procedure, can be enrolled in the study, but are stratified in a separate stratum before randomization. 4. Patients must be ? 18 years of age. 5. ECOG performance status 0,1 or 2. 6. Measurable disease; al least one of the following criteria: ? monoclonal protein >10 g/L in serum ? amyloid-forming (involved) FLC >75 mg/L with an abnormal K/? ratio ? difference between involved and uninvolved FLC >50 mg/L ? bone marrow with a clonal predominance 7. Symptomatic organ involvement 8. Hemoglobin ?11 g/dL, absolute neutrophil count ?1500/mcL, platelets ?140,000/mcL. 9. Total bilirubin <2.5 mg/dL, alkaline phosphatase <5 × u.l.n., ALT <3 × u.l.n.. 10. Estimated glomerular filtration rate (eGFR) by the MDRD formula >30 ml/min. 11. Only patients who are informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional, national and European guidelines are eligible to participate. 12. Women must be either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control 13. Men must agree to use an acceptable method for contraception for the duration of the study.

1. Amyloid-specific syndrome 2. Isolated soft tissue involvement. 3. Presence of non-AL amyloidosis. 4. Previous treatment for plasma cell disease. 5. Bone marrow plasma cells >30%. 6. Cardiac stage III disease: both cTnT > 0.035 ng/mL (or in place of cTnT the cTnI > 0.10 ng/mL) and simultaneous NT-proBNP >332 ng/L. 7. Repetitive ventricular arrhythmias on 24h Holter ECG in spite of anti-arrhythmic treatment or chronic atrial fibrillation 8. Supine systolic blood pressure <100 mmHg or symptomatic orthostatic hypotension or clinically important autonomic disease 9. Grade 3 sensory or grade 1 painful peripheral neuropathy. 10. Patients with AL who are eligible for ASCT with 200 mg/m2 of melphalan. These are patients <65 years of age, without cardiac involvement (determined according to the consensus criteria), with eGFR >51mL/min, left ventricular ejection fraction >45%, and bilirubin <2.0 mg/dL. 11. Pregnant or nursing women. 12. Clinically overt multiple myeloma with lytic bone lesions 13. Patients with uncontrolled infection or active malignancy with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years. 14. Patients with medically documented cardiac syncope, uncompensated NYHA Class 3 or 4 congestive heart failure, or myocardial infarction within the previous 6 months are not eligible. 15. HIV positive. 16. Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study. 17. Patients with hypersensitivity to bortezomib, boron or mannitol.

Hematologic response after 3 cycles of therapy. Respuesta hematológica después de 3 ciclos de terapia

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

Si
No

No
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

No
No

Si
No

Si

Centros participantes:


Si
No
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO:

3
6
  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:


40

Para estudios internacionales:


105
110

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha