Hemotrial Un proyecto de SEHH

Ensayo clínico

Estudio Fase II aleatorizado y abierto de CNTO328 (anticuerpo monoclonal anti-IL-6) y VELCADE-Melfalán-Prednisona comparado con Velcade-Melfalán-Prednisona para el tratamiento del Mieloma Múltiple no tratado previamente

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Resumen

2017-03-15 04:10:24
2008-007157-12
CNTO328MMY2001
Estudio Fase II aleatorizado y abierto de CNTO328 (anticuerpo monoclonal anti-IL-6) y VELCADE-Melfalán-Prednisona comparado con Velcade-Melfalán-Prednisona para el tratamiento del Mieloma Múltiple no tratado previamente
CNTO328MMY2001

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Centocor BV Netherlands

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
CNTO 328
CNTO 328 Solution for infusion
Intravenous use

Detalles del Fármaco (Principio Activo):
CNTO 328 Chimeric murine

Concentración del fármaco:
mg/ml milligram equal

18

Contenido del fármaco

No
Si

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

Si
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General

Mielomas

Mieloma Múltiple Sintomático

Part 1 of the trial:To assess the safety of CNTO 328 at a dose of 11 mg/kg every 3 weeks when administered in combination with VMP.Part 2 of the trial:To demonstrate improved efficacy, as assessed by complete response (CR) rate using the European Group for Blood and Marrow transplantation (EBMT) criteria, of CNTO 328 in combination with VMP compared with VMP.

Part 1 of the trial:To explore the efficay, pharmacokinetics, and pharmacodynamics of CNTO 328 in combination with VMP.Part 2 of the trial:To assess additional measures of clinical benefit, safety, pharmacokinetics, and pharmacodynamics of CNTO 328 in combination with VMP.

No


1. Age ?18 years old2. Subjects must have signed informed consent indicating that they understand the purpose of and procedures required for the study, and are willing to participate in the study. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of ? 24. Confirmed diagnosis of multiple myeloma (International Myeloma Working Group [IMWG] criteria requiring treatment5. Subject is not a candidate for high dose chemotherapy with stem cell transplantation due to:a. Age ? 65 years, orb. In subjects < 65 years: presence of important comorbid condition(s) likely to have a negative impact on the tolerability of high dose chemotherapy with stem cell transplantation. Sponsor review of these comorbid conditions and approval is required before randomization. 6. Measurable secretory disease, defined as either serum monoclonal paraprotein (M protein) ? 1 g/dL or urine monoclonal (light chain) protein > 200 mg/24 hours7. Have pretreatment clinical laboratory values meeting the protocol criteria within 14 days before treatment8. Female subjects must be postmenopausal (at least 12 months since last menses), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control; Men must be sterilized or agree to use a double barrier method of birth control and must agree to not donate sperm during the study and for 6 months after the last administration of study agent.9. Subjects must be able to adhere to study visit schedule and all protocol requirements.10. The anticipated life expectancy is such that the subject will be able to participate for the duration of the study

1. Diagnosis of primary amyloidosis, asymptomatic or smoldering multiple myeloma or monoclonal gammopathy of undetermined significance (MGUS)2. Diagnosis of Waldenström?s disease, or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions3. Prior or current systemic therapy or stem cell transplantation for multiple myeloma (including, corticosteroids, clarithromycin, mAbs, immunotherapy, investigative therapy, or immunosuppressive therapy) with the exception of emergency use of a short course (maximum 4 days) of corticosteroids before treatment4. Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events 5. Radiation therapy within 14 days before treatment6. Plasmapheresis within 14 days before treatment7. Major surgery within 14 days before treatment 8. Transplanted solid organ, with the exception of a > or = 3 months before treatment corneal transplant9. History of allergic reaction or hypersensitivity to boron or mannitol, or known allergies or clinically significant reactions to murine, chimeric, or human proteins10. Concurrent medical condition or disease 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 study11. Serious concurrent illness or history of uncontrolled heart disease such as unstable angina, congestive heart failure, myocardial infarction within preceding 12 months, or clinically significant rhythm or conduction abnormality12. Prior or concomitant malignancy except adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancer for which the subject has undergone potentially curative therapy and has no evidence of that disease for ? 5 years13. Vaccinated with live, attenuated vaccines within 4 weeks of the first administration of CNTO 32814. Known infection with HIV, known hepatitis C infection, or known to be hepatitis B surface antigen positive15. Use of any investigational agents within 30 days or 5 half lives of treatment16. Pregnant or lactating women

Safety for Part 1 and CR rate, based on the EBMT criteria for Part 2

Fase II
  DISEÑO DEL ENSAYO:

Si
Si

Si
No

No
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
No

Si
No

Si

Centros participantes:

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

5
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:

9

Para estudios internacionales:

44
116

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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