Hemotrial Un proyecto de SEHH

Ensayo clínico

Ensayo Clínico fase 3, aleatorizado, en régimen abierto de Tanespimicina (KOS-953) más Bortezomib en comparación con Bortezomib solo, en pacientes con Mieloma Múltiple en primera recaída.Phase 3 Randomized, Open-Label Clinical Trial of Tanespimycin (KOS-953) plus Bortezomib Compared to Bortezomib Alone in Patients with Multiple Myeloma in First Relapse

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Resumen

2017-03-15 04:06:03
2007-004138-17
KAG-301
Ensayo Clínico fase 3, aleatorizado, en régimen abierto de Tanespimicina (KOS-953) más Bortezomib en comparación con Bortezomib solo, en pacientes con Mieloma Múltiple en primera recaída.Phase 3 Randomized, Open-Label Clinical Trial of Tanespimycin (KOS-953) plus Bortezomib Compared to Bortezomib Alone in Patients with Multiple Myeloma in First Relapse
KAG-301

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
KOSAN BIOSCIENCES, INC. United States

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test Velcade®
Janssen-Cilag International NV Tanespimycin
KOS-953 Suspension for injection
Intravenous use

Detalles del Fármaco (Principio Activo):
KOS-953 17-AAG

Concentración del fármaco:
mg/ml milligram 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 2:
Comparator
Velcade
Powder for solution for injection
Intravenous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:
mg milligram(s) equal

3,5

Contenido del fármaco

Si
No

No
Information no disponible en EudraCT

No
No

No
No

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General

Mielomas

Pacientes con un mieloma múltiple en primera recaída tras el fracaso de tratamientos antineoplásicos previos y/o un trasplante de médula ósea.Patients with multiple myeloma in first relapse after failure of previous anti-cancer therapy and/or bone marrow


To compare the progression-free survival (PFS) associated with the use of tanespimycin (KOS-953) in combination with bortezomib versus that associated with administration of bortezomib alone for the therapy of patients with multiple myeloma in first relapse.

To compare the overall survival in each arm To compare the time to progression in each arm To compare the objective response rate, including CR and PR rate, in each arm, using EBMT/IBMTR criteriaFor those patients who achieve an objective response, to compare the time to tumor response and duration of responseTo compare the time to treatment failure in each arm To determine the relative safety profile of each treatment armTo assess the relative health-related quality of life of patients in each treatment armTo evaluate the pharmacoeconomic implications of the addition of tanespimycin to standard BZ therapy, using selected measures of health care utilization(In patients at selected sites): to determine the pharmacokinetics of tanespimycin using a sparse sampling protocolTo explore the effects of tanespimycin in combination with BZ in objectively defined patient subgroups based on laboratory values from serially obtained research serum and plasma

No


1. Age ? 18 years2. KPS performance status ? 70%3. All patients must have documented evidence of multiple myeloma. All patients must have documented progression of disease after initial response to one line of therapy (either relapse from CR or progressive disease by EBMT/IBMTR criteria; see Section 5.3.1). Patients who proceeded to high-dose chemotherapy followed by stem cell transplantation (autologous or allogeneic; myeloablative or non-myeloablative; single or tandem) without documented progressive disease prior to SCT remain eligible for this protocol. Patients who received maintenance therapy following the SCT also remain eligible for this protocol, provided progression by EBMT/IBMTR criteria was not observed between SCT and initiation of maintenancetherapy. If the patient begins a second antimyeloma agent (for example, dexamethasone) without documented prior progression on the single-agent therapy, this will count as one regimen 4. All patients must have measurable disease (serum M-protein > 0.5 g/dL or > 200 mg urinary M-protein excretion/24-hour). (Patients who meet these criteria for measurable disease must also meet requirement for documentation of progressive disease by EBMT criteria). Patients with non-secretory or oligosecretorydisease are not eligible for the study. Disease must be assessed within 14 days prior to randomization5. For those patients who received prior bortezomib or a bortezomib-containing regimen: patients must have achieved a CR or PR by EBMT/IBMTR criteria. Patients may not have received a bortezomib-containing regimen following SCT as maintenance therapy6. All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to NCI CTCAE (v. 3.0) Grade ? 2 (except for neuropathy and diarrhea which must be Grade ? 1 and painful neuropathy which must have resolved)7. The following laboratory results, within 14 days of randomization: Hemoglobin ? 7.5 g/dL (if transfused within 14 days of randomization, pre- transfusion hemoglobin ? 7 g/dL) Absolute neutrophils count ? 0.750 x 10 to the 9/L (with or without growth factor support within 14 days of randomization) Platelet count ? 50 x 10 to the 9/L (without platelet transfusions within 14 days prior to randomization; if transfused within 14 days of randomization, pre-transfusion platelet count must be ? 50 x 10 to the 9/L) Total bilirubin ? 2 x ULN AST ? 2.5 x ULN Serum creatinine ? 2 x ULN or ? 20 mL/min CrCL Pregnancy test (serum or urine): negative (in all women of child-bearing potential)8. Signed informed consent.

1. Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile or they must agree to use a physical method of contraception or agree to complete sexual abstinence throughout her participation on trial. Female patients with childbearing potential must have a negative pregnancy test within 14 days prior to randomization. Male patients must be surgically sterile or agree to use an acceptable method of contraception, including abstinence2. Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 21 days prior to randomization (14 days for non-myelosuppressive therapy in which drug-related toxicities have resolved perInclusion Criterion #6). Patients should be 6 weeks from last dose of nitrosourea or monoclonal antibody, 10 weeks from autologous SCT, and 16 weeks from allogeneic SCT3. For patients who have received prior allogeneic SCT: patients with moderate-to-severe chronic graft versus host disease (GvHD) as defined in Filipovich et al 20054. Treatment with plasmapheresis within 30 days prior to randomization5. Prior therapy with a heat shock protein 90 inhibitor or an investigational proteasome inhibitor6. Concurrent use of corticosteroids other than low dose oral prednisone of 5 mg qd or less (or its equivalent); inhaled corticosteroids for the treatment of pulmonary disease that result in little-to-no systemic absorption are permitted. Patientscurrently receiving corticosteroids at a higher dose must have corticosteroids safely tapered to this level at least 7 days prior to randomization to be eligible7. Grade 3 dyspnea (dyspnea with activities of daily living) or a requirement for supplemental oxygen8. Known or suspected cardiac amyloidosis; POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes), or plasma cell leukemia (defined as either 20% of peripheral WBCcomprised of CD138+ cells or an absolute count of 2 x 10 to the 9 /L) 9. Known hepatitis A, B or C viral infection; HIV infection10. Any medical conditions that, in the Investigator’s opinion, would impose excessive risk to the patient. Examples of such conditions include congestive heart failure of Class III or IV of the NYHA classification, infection requiring parenteral antiinfective treatment, any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent

Primary Endpoint is PFS, defined as the time from randomization to first objective documentation of tumor progression or to death due to any cause.

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:

2
9
  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:

28

Para estudios internacionales:

224
466

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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