Hemotrial Un proyecto de SEHH

Ensayo clínico

A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled, 3-Arm Parallel Group Study to Determine the Efficacy and Safety of Lenalidomide (Revlimid) in Combination with Melphalan and Prednisone Versus Placebo Plus Melphalan and Prednisone in Subjects with Newly Diagnosed Multiple Myeloma Who Are 65 Years of Age or OlderESTUDIO DE FASE III, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE 3 GRUPOS PARALELOS PARA DETERMINAR LA EFICACIA Y SEGURIDAD DE LENALIDOMIDA (REVLIMID?) EN COMBINACIÓN CON MELFALÁN Y PREDNISONA FRENTE A PLACEBO MÁS MELFALÁN Y PREDNISONA EN PACIENTES CON MIELOMA MÚLTIPLE RECIÉN DIAGNOSTICADO DE 65 AÑOS DE EDAD O MAYORES

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A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled, 3-Arm Parallel Group Study to Determine the Efficacy and Safety of Lenalidomide (Revlimid) in Combination with Melphalan and Prednisone Versus Placebo Plus Melphalan and Prednisone in Subjects with Newly Diagnosed Multiple Myeloma Who Are 65 Years of Age or OlderESTUDIO DE FASE III, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE 3 GRUPOS PARALELOS PARA DETERMINAR LA EFICACIA Y SEGURIDAD DE LENALIDOMIDA (REVLIMID?) EN COMBINACIÓN CON MELFALÁN Y PREDNISONA FRENTE A PLACEBO MÁS MELFALÁN Y PREDNISONA EN PACIENTES CON MIELOMA MÚLTIPLE RECIÉN DIAGNOSTICADO DE 65 AÑOS DE EDAD O MAYORES


Resumen

2017-03-15 03:59:33
2006-001865-41
CC-5013-MM-015
A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled, 3-Arm Parallel Group Study to Determine the Efficacy and Safety of Lenalidomide (Revlimid) in Combination with Melphalan and Prednisone Versus Placebo Plus Melphalan and Prednisone in Subjects with Newly Diagnosed Multiple Myeloma Who Are 65 Years of Age or OlderESTUDIO DE FASE III, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE 3 GRUPOS PARALELOS PARA DETERMINAR LA EFICACIA Y SEGURIDAD DE LENALIDOMIDA (REVLIMID?) EN COMBINACIÓN CON MELFALÁN Y PREDNISONA FRENTE A PLACEBO MÁS MELFALÁN Y PREDNISONA EN PACIENTES CON MIELOMA MÚLTIPLE RECIÉN DIAGNOSTICADO DE 65 AÑOS DE EDAD O MAYORES
CC-5013-MM-015

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Celgene International Sàrl Switzerland

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test REVLIMID 5 mg cápsulas duras
CELGENE EUROPE LTD. Lenalidomide
CC-5013 Capsule, hard
Oral use

Detalles del Fármaco (Principio Activo):

CC-5013 3-(4-amino-1-ox

Concentración del fármaco:

mg milligram(s) equal

2.5

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 2:
Test REVLIMID 10 mg càpsulas duras
CELGENE EUROPE LTD. melphalan
Capsule, hard
Oral use

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:
Test REVLIMID 15 mg cápsulas duras
CELGENE EUROPE LTD. prednisone
Capsule, hard
Oral use

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 4:
Test REVLIMID 25 mg cápsulas duras
CELGENE EUROPE LTD. prednisone
Capsule, hard
Oral use

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 5:
Test Alkeran
Glaxo Smith Kline prednisone
Capsule, hard
Oral use

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 6:
Test Encorton 1mg
Polfa Pabianice prednisone
Tablet
Oral use

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 7:
Test Encorton 5mg
Polfa Pabianice prednisone
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

LENALIDOMIDA

Concentración del fármaco:

mg milligram(s) equal

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 8:
Test Encorton 10mg
Polfa Pabianice prednisone
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

LENALIDOMIDA

Concentración del fármaco:

mg milligram(s) equal

10

Concentración del fármaco:

mg milligram(s) equal

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 9:
Test Encorton 20mg
Polfa Pabianice
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

LENALIDOMIDA

Concentración del fármaco:

mg milligram(s) equal

15

Concentración del fármaco:

mg milligram(s) equal

10

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 10:
Test Prednisone Hexal 50mg'
Hexal AG
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

LENALIDOMIDA

Concentración del fármaco:

mg milligram(s) equal

25

Concentración del fármaco:

mg milligram(s) equal

20

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 11:
Test Prednison 50mg Galen
GalenPharma GmbH
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

2

Concentración del fármaco:

mg milligram(s) equal

50

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 12:
Test
Tablet
Oral use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

mg milligram(s) equal

1

Concentración del fármaco:

mg milligram(s) equal

50

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

Multiple MyelomaMieloma Múltiple


To determine the efficacy of lenalidomide plus melphalan and prednisone (MPR) compared to placebo plus melphalan and prednisone (MP) in subjects with newly diagnosed multiple myeloma (MM) who are 65 years of age or older.

To assess the safety of MPR compared to placebo plus MP in subjects with newly diagnosed MM who are 65 years of age or older.

No


1. Must understand and voluntarily sign an informed consent form 2. Age equal to or greater than 65 years at the time of signing the informed consent3. Newly diagnosed with symptomatic multiple myeloma as defined by the 3 criteria below: ? MM diagnostic criteria (all 3 required)? Monoclonal plasma cells in the bone marrow ?10% and/or presence of a biopsy proven plasmacytoma? Monoclonal protein present in the serum and/or urine? Myeloma-related organ dysfunction AND have measurable disease as defined by the following;? IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ? 1.0 g/dL or urine M-protein level ? 200 mg/24 hours? IgA multiple myeloma: Serum M-protein level ? 0.5 g/dL or urine M-protein level ? 200 mg/24 hours? IgD multiple myeloma: Serum M-protein level ? 0.05 g/dL or urine M-protein level ? 200 mg/24 hours? Light chain multiple myeloma: Serum M-protein level ? 1.0 g/dL or urine M-protein level ? 200 mg/24 hours? IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ? 1.0g/dL or urine M-protein level ? 200mg/24hours4. Karnofsky performance status ? 60%.5. Able to adhere to the study visit schedule and other protocol requirements.6. Women of childbearing potential (WCBP) must:a. Have a negative medically supervised pregnancy test prior to start of studytherapy. She must agree to ongoing pregnancy testing during the course of thestudy, and after end of study therapy. (See specifics in Appendices). This applieseven if the subject practices complete and continued sexual abstinence.b. Either commit to continued abstinence from heterosexual intercourse (which mustbe reviewed on a monthly basis) or agree to use, and be able to comply with,effective contraception without interruption, 28 days prior to starting study drug,during the study therapy (including dose interruptions), and for 28 days afterdiscontinuation of study therapy. (See specifics in Appendices)7. Male subjects must:a. Agree to use a condom during sexual contact with a WCBP, even if they have hada vasectomy, throughout study drug therapy, during any dose interruption andafter cessation of study therapy. (See specifics in Appendices)b. Agree to not donate semen during study drug therapy and for a period after end ofstudy drug therapy. (See specifics in Appendices)8. All subjects must:a. Have an understanding that the study drug could have a potential teratogenic risk.b. Agree to abstain from donating blood while taking study drug therapy andfollowing discontinuation of study drug therapy. (See specifics in Appendices)c. Agree not to share study medication with another person.d. All patients must be counseled about pregnancy precautions and risks of fetalexposure. (See Appendix: Education and Counseling Guidance Document)

1. Previous treatment with antimyeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 28 days [4 weeks] of randomisation]). 2. Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds experimental the ability to interpret data from the study.3. Pregnant or lactating females. 4. Radiotherapy within 14 days (2 weeks) of randomisation.5. Plasmapheresis within 28 days (4 weeks) of randomisation.6. Any of the following laboratory abnormalities:? Absolute neutrophil count (ANC) < 1,500 cells/µL (1.5 x 10.9/L)? Platelet count < 75,000/µL (75 x 10.9/L) for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; but platelet count <30,000/mcrL for subjects in whom ? 50% of bone marrow nucleated cells are plasma cells ? Haemoglobin < 8.0 g/dL (80 g/L)? Serum creatinine > 2.5 mg/dL (221 µmol/L)? Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)7. Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for ? 3 years. Exceptions include the following:? Basal cell carcinoma of the skin? Squamous cell carcinoma of the skin? Carcinoma in situ of the cervix? Carcinoma in situ of the breast? Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)8. Neuropathy of ? grade 2 severity.9. Known HIV positivity or active infectious hepatitis, type A, B or C.

Progression free survival (defined as time from randomisation to the first documentation of progressive disease based on the European Group for Blood and Marrow Transplantation/International Bone Marrow Transplant Registry/Autologous Bone Marrow Transplant Registry [EBMT/IBMTR/ABMTR] criteria, or death due to any cause during the treatment phase).

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

No
No

Si
Si

No
Si
  COMPARADOR DEL ENSAYO CONTROLADO:

No
Si

Si
No

Si

Centros participantes:


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

6
3
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO EN ESPAÑA:


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

Rango de edad:


0
0

1

Sexo:


1
1

Número planeado de pacientes a incluir:


32

Para estudios internacionales:


295
450

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


EC Finalizado



EC Finalizado