Hemotrial Un proyecto de SEHH

Ensayo clínico

An Open-Label, Randomized Study of VELCADE/Melphalan/Prednisone versus Melphalan/Prednisone in subjects with previously untreated Multiple Myeloma.

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Resumen

2017-03-15 03:55:48
2004-001989-41
26866138-MMY-3002
An Open-Label, Randomized Study of VELCADE/Melphalan/Prednisone versus Melphalan/Prednisone in subjects with previously untreated Multiple Myeloma.
Velcade-MMY-3002
26866138-MMY-3002

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Janssen-Cilag S.A. Spain

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Comparator Dacortin 5mg
Merck KGaA Decortin, prednisone 5 mg tablets for oral use
PS-341 Tablet
Oral use

Contenido del fármaco


Si
No

Information no disponible en EudraCT
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  FÁRMACO 2:
Test Velcade
Janssen-Cilag International NV VELCADE3,5 mg powder for solution for injection
Powder for solution for injection
Intravenous bolus use (Noncurrent)

Detalles del Fármaco (Principio Activo):

Boronic Acid: [

Concentración del fármaco:

mg milligram(s) equal

5

Contenido del fármaco


Si
No

Information no disponible en EudraCT
Information no disponible en EudraCT

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  FÁRMACO 3:
Comparator Alkeran Tablets 2 mg
GlaxoSmithKline UK Alkaran 2 mg film-coated tablets for oral use
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

Bifunctional al

Concentración del fármaco:

mg milligram(s) equal

3.5

Concentración del fármaco:

mg milligram(s) equal

2

Contenido del fármaco


Si
No

Information no disponible en EudraCT
Information no disponible en EudraCT

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Information no disponible en EudraCT
  FÁRMACO 4:
Comparator Decortin
Merck KGaA Decortin, prednisone 20 mg tablets for oral use
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

20

Contenido del fármaco


Si
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
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Information no disponible en EudraCT

Information no disponible en EudraCT
  FÁRMACO 5:
Comparator Decortin
Merck KGaA Decortin, prednisone 50 mg tablets for oral use
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

50

Contenido del fármaco


Si
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
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  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General



Mielomas

First-Line Multiple Myeloma


The primary efficacy objective of this study is to determine whether the addition of VELCADE to standard MP therapy improves the TTP in subjects with previously untreated multiple myeloma.

The secondary objectives of this study are to determine whether the addition of VELCADE to standard MP therapy in subjects with previously untreated multiple myeloma improves the following: OS, CR rate, overall response rate (CR + PR), time to response, and duration of response. An additional secondary objective is to measure and test global health status as measured by the EORTC QLQ-C30, a patient-reported outcome (PCO) instrument.

Information no disponible en EudraCT


Male or femaleSubject is not a candidate for HDT/SCT due to: age - subject is 65 years or older.OR in subjects less than 65 years of age - presence of important comorbid condition(s) likely to have a negative impact on tolerability of HDT/SCT. Sponsor review of these comorbid conditions and approval is required before randomization.Symptomatic multiple myeloma or asymptomatic multiple myeloma with related organ or tissue damage. Asymptomatic multiple myeloma-related organ or tissue damage can include presence of asymptomatic lytic bone lesion or plasmacytoma, or presence of anemia (hemoglobin <10 g/dL), renal function impairment (serum creatinine > upper limit of normal [ULN]) or hypercalcemia (serum calcium >ULN), as long as the criteria for pre-treatment clinical laboratory values indicated below are met.Presence of measurable disease, defined as: For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value (>1 g/dL of IgG or IgM M-protein, >0.5 g/dL of IgA M-protein, >0.05 g/dL of IgD M protein, OR urine light-chain excretion of more than 200 mg/24 hours).For oligosecretory or nonsecretory multiple myeloma, measurable disease is defined by the presence of measurable soft tissue or organ (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e., magnetic resonance imaging [MRI], computed tomography [CT] scan). A measurable lesion is defined as a lesion with minimum largest diameter of >20 mm (if measured by conventional techniques such as physical examination, conventional CT scan, or MRI) or of >10 mm (if measured by spiral CT scan) in one dimension. Oligosecretory myeloma is defined as the presence of M-protein in serum or urine but in quantities less than indicated above. Nonsecretory multiple myeloma is defined as the absence of M protein in serum and in urine by immunofixation.Karnofsky performance status score >60%Have pretreatment clinical laboratory values meeting the following criteria within 14 days before randomization:-platelet count greater or equal to 100x10*9/L-hemoglobin greater or equal than 8 g/dL (greater or equal than 4.96 mmol/L) (prior RBC transfusion or recombinant human erythropoietin use is allowed)-absolute neutrophil count (ANC) greater or equal than 1.0x109/L-aspartate aminotransferase (AST) smaller or equal than 2.5 times the upper limit of normal -total bilirubin lower or equal than 1.5 times the upper limit of normal-serum creatinine smaller or equal to 2mg/dL (smaller or equal to176.8 mcmol/L)-corrected serum calcium <14 mg/dL (<3.5 mmol/L)

Diagnosis of smoldering multiple myeloma or MGUS. Smoldering multiple myeloma is defined as asymptomatic multiple myeloma with absence of lytic bone lesions. MGUS is defined by presence of serum monoclonal protein <3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the monoclonal protein; and (if determined) proportion of plasma cells in the bone marrow of 10% or less.Diagnosis of Waldenstrom's disease or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.Prior or current systemic therapy for multiple myeloma including steroids (with exception of emergency use of a short course [maximum 4 days] of steroids before randomization or of prior or current use of bisphosphonates) Radiation therapy within 30 days before randomizationPlasmapheresis within 30 days before randomization Major surgery within 30 days before randomization (Kyphoplasty is not considered major surgery) History of allergic reaction attributable to compounds containing boron or mannitolPeripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 Uncontrolled or severe cardiovascular disease, including myocardial infarction, within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure (see Attachment 3), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosisOther malignancy within the past 5 years. Exceptions for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervixConcurrent medical condition or disease (e.g., active systemic infection, uncontrolled diabetes) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this studyUse of any investigational drugs within 30 days before randomization

The primary end point of this study is TTP in the intent-to-treat subject population. Time to progression is a meaningful end point in an elderly patient population with multiple myeloma for whom currently available treatment options are not curative and can only delay disease progression. Overall survival was chosen only as a secondary end point due to the likelihood of cross-over of subjects on the control arm to commercially available VELCADE or a VELCADE-containing regimen as subsequent therapy.

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

Si
No

No
No

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
No

No
No

Si

Centros participantes:


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

6
0
  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:


450
680

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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En Marcha