Hemotrial Un proyecto de SEHH

Ensayo clínico

A Phase II, Open-Label Trial Using VELCADE for Re-Treatment of Multiple Myeloma Subjects Following an Initial Response to VELCADE

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Resumen

2017-03-15 03:58:52
2005-005819-26
26866138-MMY-2036
A Phase II, Open-Label Trial Using VELCADE for Re-Treatment of Multiple Myeloma Subjects Following an Initial Response to VELCADE
26866138-MMY-2036

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Janssen-Cilag EMEA Medical Affairs Belgium

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test VELCADE
Janssen-Cilag International N.V. VELCADE 3.5 mg powder for solution for injection
PS-341, 2686613 Powder for solution for injection
Intravenous use

Detalles del Fármaco (Principio Activo):

26866138 Boronic Acid: [

Concentración del fármaco:

mg/m2 milligram equal

1.3

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General



Mielomas

multiple myeloma


To determine best response to VELCADE re-treatment in multiple myeloma subjects who have previously responded to a VELCADE based therapy.

· Determine the incidence of SAEs, Grade 3 and 4 AEs, and all grades of neuropathy from each subject at baseline and every 6 weeks during treatment.· Determine best confirmed M-protein response to VELCADE re-treatment in multiple myeloma subjects who have previously responded to VELCADE.· Determine the DOR and TTP.

Information no disponible en EudraCT


1. Male or female subject, aged >= 18 years.2. Subject has given voluntary written informed consent before performance of any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.3. Subject was previously diagnosed with multiple myeloma based on standard criteria and has measurable disease. Measurable disease for secretory multiple myeloma is defined as any quantifiable serum monoclonal protein value (generally, but not exclusively, greater than 1 g/dL of immunoglobulin G (IgG) M-Protein and greater than 0.5g/dL immunoglobulin A (IgA)) or urine light-chain excretion of >= 200 mg/24 hours.4. Subject previously tolerated 1.0 or 1.3 mg/m2/dose of VELCADE alone or in combination with other agents and had CR or PR upon completion of VELCADE therapy.5. It has been >= 6 months since the subject's last VELCADE dose and the subject has Progressive Disease (PD) if prior response to VELCADE was PR or subject has relapsed from CR. PD or relapse are defined as one or more of the following criteria:Criteria for PD for subjects that had PR to previous VELCADE course:· >25% increase in either serum or urine M-protein;· >25% increase in plasma cells on bone marrow;· Definite increase in size of bone lesion or plasmacytoma;· Development of new bone lesion or plasmacytoma; or· Development of hypercalcemia (corrected serum calcium >11.5 mg/dl or 2.8 mmol/l) not attributable to other causes.Criteria for relapse from CR:· Reappearance of serum or urinary paraprotein on immunofixation or routine electrophoresis, confirmed by at least one further investigation and excluding oligoclonal immune reconstitution· >5% plasma cells in bone marrow aspirate or on trephine bone biopsy· Development of new lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions· Development of hypercalcemia (corrected serum calcium >11,5 mg/dl or 2.8 mmol/l) not attributable to any other cause.6. Subject has a Karnofsky performance status >=60% (see Attachment 1: Karnofsky Performance Status Scale).7. Subject has a life-expectancy >3 months.8. Subject has the following laboratory values within 14 days before enrolment (Day 1, Cycle 1, before drug administration):· Platelet count >=50 x 10 exp.9/L without transfusion support within the 7 days before the test; · Hemoglobin >=7.5 g/dL without transfusion support within 7 days before the test;· Absolute neutrophil count (ANC) >=0.75 x 10 exp.9/L without the use of growth factors; · Corrected serum calcium <14 mg/dL (3.5 mmol/L);· Aspartate aminotransferase (AST) <=2.5 x the upper limit of normal (ULN);· Alanine aminotransferase (ALT) <=2.5 x the ULN;· Total bilirubin <=1.5 x the ULN; and· Calculated or measured creatinine clearance >=20 mL/minute (see Attachment 2: Creatinine Clearance Calculation for formula to calculate clearance from serum creatinine).9. If female, the subject is either postmenopausal or surgically sterilised or willing to use an acceptable method of birth control (i.e., total abstinence - periodic abstinence can not be allowed -, a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide) from screening through at least 30 days after completion of the last treatment cycle.10. If male, the subject agrees to use an acceptable barrier method for contraception from screening through at least 30 days after completion of the last treatment cycle.

1. Subjects with a history of PD, minimal response, or stable disease (SD) on last exposure to VELCADE.2. Subject has received chemotherapy, radiotherapy, antibody, immunotherapy, or experimental therapy to treat multiple myeloma since their last dose of VELCADE. Note: Subjects can have received localized palliative radiotherapy for complications due to osteolytic bone lesions. Subjects can have received steroids (cumulative exposure of up to 160 mg of Dexamethasone or equivalent) or thalidomide or Interferon as maintenance therapy since their last dose of VELCADE. Subjects can have received high dose therapy/stem cell transplantation after VELCADE containing induction regimen, only if PR or CR was observed during VELCADE containing induction therapy.3. Subjects who achieved a CR or PR but relapsed while on therapy.4. Subject has oligosecretory or non-secretory multiple myeloma.5. Subject had major surgery within 4 weeks before enrolment. (Kyphoplasty is not considered major surgery.)6. Subject has a history of allergic reaction to VELCADE or attributable to compounds containing boron or mannitol.7. Subject has peripheral neuropathy or neuropathic pain of >= Grade 2, as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0.8. Subject has cardiac amyloidosis.9. Subject has an uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months of enrolment or had New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.10. Subject has poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.11. Subject had another 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 cervix.12. Subject is known to be human immunodeficiency virus (HIV)-positive. (Subjects assessed by the investigator to be at risk for HIV infection should be tested in accordance with local policies).13. Subject is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection. (Subjects assessed by the investigator to be at risk for hepatitis B or C infection should be tested in accordance with local policies).14. Subject has an active systemic infection requiring treatment.15. Female subject is pregnant or breast feeding. Confirmation that the subject is not pregnant must be established by a negative serum B-HCG pregnancy test result obtained during the Screening period. Pregnancy testing is not required for post-menopausal16. Subjects that have been previously enrolled in this trial17. Subjects that have taken any experimental therapy or used any experimental device within 30 days prior to the enrolment.

To determine best response to VELCADE re-treatment in multiple myeloma subjects who have previously responded to a VELCADE based therapy.

Fase II
  DISEÑO DEL ENSAYO:

Si
No

Si
No

No
No

No
Si
  COMPARADOR DEL ENSAYO CONTROLADO:

No
No

No
No

Si

Centros participantes:


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

2
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:


30

Para estudios internacionales:


125
125

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


Por Determinar



En Marcha