Hemotrial Un proyecto de SEHH

Ensayo clínico

A Phase 2, Randomized, Double-blind, Placebo-controlled Study Comparing the Combination of CNTO 328 (Anti-IL-6 Monoclonal Antibody) and Velcade® versus Velcade alone in Subjects with Relapsed or Refractory Multiple Myeloma

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Resumen

2017-03-15 03:59:38
2006-001904-36
C0328T06
A Phase 2, Randomized, Double-blind, Placebo-controlled Study Comparing the Combination of CNTO 328 (Anti-IL-6 Monoclonal Antibody) and Velcade® versus Velcade alone in Subjects with Relapsed or Refractory Multiple Myeloma
C0328T06

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Centocor B.V. 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

20

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:
  PLACEBO 1:

Si
Solution for infusion

Intravenous use

Información General

Mielomas

relapsed or refractory multiple myeloma

The primary objective of Part I is to assess the safety of CNTO 328 when administered as an IV infusion in combination with bortezomib in subjects with relapsed or refractory multiple myeloma. The primary objective of Part II of the study is to compare the efficacy, in terms of progression-free survival (PFS) of CNTO 328 when administered as an IV infusion in combination with bortezomib alone in subjects with relapsed or refractory multiple myeloma.

The secondary objectives of the study are to assess the other efficacy endpoints, safety, population pharmacokinetics, pharmacodynamics, and immune response of CNTO 328 in subjects with relapsed or refractory multiple myeloma.

No


To be eligible for the study, subjects must meet all of the following criteria:1. Male or female age ? 18 years2. Signed informed consent obtained prior to any study-specific screening procedures3. Confirmed diagnosis of multiple myeloma4. Measurable secretory disease defined as either serum monoclonal paraprotein, (M-protein) ?1 g/dL or urine monoclonal (light chain) protein (> 200 mg/24 hours)5. Documented disease progression (according to EBMT criteria) after at least 1 prior line of therapy but no more than 3 or have had no response to previous treatment (primary refractory disease), or have undergone or are unsuitable for autologous hematopoietic stem cell transplantationa. A single line of therapy may consist of 1 or more drugs such as, melphalan plus prednisone; vincristine plus conventional doxorubicin (or Doxil/Caelyx) plus dexamethasone (VAD/DVd); lenalidomide; or high-dose pulse corticosteroid with or without thalidomide (rituximab alone or experimental agents alone should not be considered a line of therapy)b. A single line of therapy may include induction chemotherapy followed by autologous hematopoietic stem cell transplantation and maintenance therapy or progression of disease before a response during the initial line of therapy (primary refractory disease) with a regimen that may have contained an anthracycline, an alkylating agent, or high-dose corticosteroids (rituximab alone or experimental agents alone should not be considered a line of therapy6. ECOG performance status score of ?27. Subjects experiencing toxicities resulting from previous therapy must have fully recovered or stabilized to ? Grade 18. Subjects of childbearing potential must use adequate birth control measures. Female subjects of childbearing potential must have a negative serum pregnancy test at screening9. Adequate bone marrow, liver, and renal function at first dose/randomization as described below:a. Hemoglobin ? 7.5 g/dL (4.7 mmol/L; 75 g/L) with or without transfusion dependencyb. Platelets ? 50,000/mm3 without transfusion dependency c. Absolute neutrophil count (ANC) ? 1000 mm3 without hematopoietic cytokine support d. AST, ALT, and alkaline phosphatase ? 3 x ULNe. Bilirubin ? 2 x ULNf. Calculated creatinine clearance ? 20 mL/min g. Corrected serum calcium < 12 mg/dL (3.0 mmol/L) or ionized calcium < 6.5 mg/dL (1.6 mmol/L). This level may be achieved by treatment but it must be reached before the subject is randomized10. Able to adhere to study visit schedule and all protocol requirements

Subjects meeting any of the following criteria may not be enrolled in the study:1. Prior treatment with bortezomib2. Hypersensitivity or allergic reactions to boron or mannitol, or compounds containing these components3. Removed the criteria that excluded subjects with prior dexamethasone exposure4. ? Grade 2 peripheral neuropathy (according to NCI CTCAE, Version 3.0)5. Treatment with systemic cancer therapy (including clarithromycin) or radiotherapy within 30 days of randomization6. Treatment with nitrosoureas within 42 days of first dose/randomization7. Major surgery within 30 days of first dose/randomization or planning to have surgery (except for minor surgical procedures) during the study8. Received any investigational drug/agent within 30 days or 5 half-lives (whichever is longer) of first dose/randomization9. Received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant10. Has clinically significant residual toxicities associated with prior autologous bone marrow or autologous peripheral blood stem cell transplant11. Administered platelet transfusion or neutrophil growth factor within 2 weeks prior to the collection of screening hematology laboratory sample12. Transplanted solid organ with the exception of a corneal transplant (? 3 months prior to first dose/randomization)13. Received any mAb within 60 days of first dose/randomization14. Serious concurrent illness (medical or psychiatric), uncontrolled infection (including acute, diffuse infiltrative pulmonary disease), or any uncontrolled medical condition (eg, uncontrolled diabetes), including the presence of laboratory abnormalities, that places the subject at unacceptable risk by participating in the study or confounds the ability to interpret data from the study15. Myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class II or higher heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic, clinically significant conduction system abnormalities, baseline QTc interval >450 milliseconds, history of hypokalemia, or any cardiac condition that is ? Grade 316. Prior or concomitant malignancy (other than multiple myeloma) 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 been disease-free for ? 3 years17. Any other concomitant disease-related treatment such as, immunotherapy, biotherapy, radiotherapy, chemotherapy, investigative therapy, or immunosuppressive therapy/corticoid steroids (other than study specific treatments)18. Vaccinated with live or attenuated vaccines within 4 weeks of the first administration of CNTO 328/placebo19. Known to be seropositive for HIV, or active hepatitis A, B or C infection 20. Pregnant or lactating women21. Known allergies or clinically significant reactions to murine or human proteins

The primary endpoints for the study are safety for Part I and progression-free survival (PFS) for Part 2.

Fase II
  DISEÑO DEL ENSAYO:

Si
Si

No
No

Si
Si

No
Si
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
Si

No
No

Si

Centros participantes:

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

2
10
  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:

20

Para estudios internacionales:

190
290

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


 EC Finalizado



EC Finalizado