Hemotrial Un proyecto de SEHH

Ensayo clínico

A Randomized Controlled Study of DOXIL/CAELYX (doxorubicin HCL liposome injection) and VELCADE (bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma

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Resumen

2017-03-15 03:55:45
2004-001842-34
DOXIL-MMY-3001
A Randomized Controlled Study of DOXIL/CAELYX (doxorubicin HCL liposome injection) and VELCADE (bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma
doxil/caelyx plus velcade versus velcade alone in relapse multiple myeloma
DOXIL-MMY-3001

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Johnson&Johnson Pharmaceutical Research and Development, Division de Janssen-Cilag Spain

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test Caelyx 2 mg/ml concentrate for solution for infusi
SP Europe DOXIL/CAELYX 50mg vial/2 mg/ml
Doxorubicin HCL Solution for infusion
Intravenous use

Contenido del fármaco

Si
No

Information no disponible en EudraCT
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  FÁRMACO 2:
Comparator Velcade
Janssen-Cilag International NV VELCADE 3.5 mg powder for solution for injection
PS-341 Powder for solution for injection
Intravenous use

Detalles del Fármaco (Principio Activo):
pegylated lipos

Concentración del fármaco:
mg/ml milligram equal

2
Boronic Acid: [

Concentración del fármaco:
mg milligram(s) equal

3.5

Contenido del fármaco

Si
No

Information no disponible en EudraCT
Information no disponible en EudraCT

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  INFORMACIÓN DE PLACEBOS USADOS:

No hay placebos asignados al ensayo

Información General

Mielomas

Recurred or relapsed multiple myeloma

The primary objective of this study is to test the hypothesis that treatment with DOXIL/CAELYX and VELCADE in combination, will result in a longer time to progression (TTP) than VELCADE monotherapy in subjects with relapsed multiple myeloma.

Secondary objectives are to compare the treatment groups for: overall survival (OS);response rate (complete + partial) using standard criteria; and safety profiles. In addition, the 2 treatment groups will be evaluated for: the impact of the treatment on the subject-reported outcomes and the impact on health economic parameters to include utilization of hospital resources and medications, and to explore the possible relationship between anthracycline dose, cardiac events, and genes that may increase the likelihood of anthracycline-induced cardiac toxicity, and the pattern of RNA expression in plasma multiple myeloma cells from bone marrow prior to the start of treatment.

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- Male or female and at least 18 years-of-age- Histologically confirmed diagnosis of multiple myeloma with evaluable disease parameters- Progressive Disease after an initial response (complete, partial, or minimal) to at least 1 line of therapy, which includes at a minimum an alkylating agent or anthracycline and corticosteroids A single line of therapy may consist of one or more cytotoxic drugs such as melphalan plus prednisone; vincristine plus doxorubicin (or DOXIL/CAELYX) plus dexamethasone; or high-dose pulse corticosteroid. A single line of therapy may include hematopoietic stem cell transplantation plus maintenance treatment as well as induction with VAD or another regimenorProgressing during initial therapy that included, at a minimum, an alkylating agent and corticosteroids- Progressive disease as defined by one of the following: >25% increase in M-protein Development of new or worsening lytic bone lesions, plasmacytoma or hypercalcemia (>11.5 mg/dL corrected) despite appropriate medical treatment- Measurable secretory disease defined as either: Quantifiable serum monoclonal antibody defined as a serum monoclonal protein >1 g/dL for immunoglobulin G (IgG), >0.5 g/dL for immunoglobulin A (IgA), or > 0.05 g/dL of immunoglobulin D (IgD) Measurable urine levels of monoclonal protein (>200mg/24 hours)- ECOG performance status of 0 or 1 - Life expectancy of at least 3 months- At randomization hematologic values within the following limits Absolute neutrophil count (ANC) > or =1,000/mm3 Platelet count > or =75,000/mm3 without transfusion support for 7 days prior to study Hemoglobin > or =8.0 g/dL without transfusion support for 7 days prior to study entry- At screening serum biochemical values within the following limits Calculated (Cockroft-Gault formula) or measured creatinine clearance of > or =30 mL/minute, whichever is greater Total bilirubin < or =1.5 x upper limit of normal (ULN) Transaminases (AST/ALT) < or =2.5 x ULN- At randomization a corrected serum calcium <12 mg/dL (3.0 mM/L). This level may be achieved by treatment but it must be reached before the subject may be randomized- Left ventricular ejection fraction (LVEF) within institutional normal limits - Recovered from the acute toxicity of any prior treatment- Female subjects must be postmenopausal, surgically sterile, or practicing an effective method of birth control before entry and throughout the study- Negative serum or urine beta-hCG pregnancy test at screening for subjects of child-bearing potential- Able to respond to health outcomes questionnaire- Subjects must have signed an informed consent document- Subjects must have signed an informed consent for genetic testing. Participation in the genetic testing component is not mandatory for participation in the study.- Subject is, in the investigator's opinion, able and willing to comply with the protocol requirements

- History of treatment with VELCADE- Progressive disease while receiving an anthracycline containing regimen- No change (NC) in disease status during initial therapy (Attachment 1: Response Criteria) - Non-secretory disease (i.e., no measurable paraprotein in serum or urine; urine paraprotein level < or = 200 mg/24 hours).- Prior treatment with doxorubicin, or equivalent, at cumulative doses in excess of 240 mg/m2 (i.e., 1 mg doxorubicin = 1 mg DOXIL/CAELYX = 1.8 mg epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin)- Peripheral neuropathy of Grade 2 or greater severity as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 - Myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure (Attachment 7), uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities- Treatment with nitrosoureas within 6 weeks- Treatment with chemotherapy (other than nitrosoureas), clarithromycin, or radiation therapy within 21 days before randomization - Treatment with immuno- or antibody therapy within 60 days before randomization- Treatment with plasmapheresis within 30 days before enrollment- Major surgery within 30 days before Day 1 Cycle 1 except for minimally invasive procedures such as kyphoplasty- Palliative radiation or surgery within 30 days prior to screening- Allergic reactions to compounds containing boron, mannitol or doxorubicin, or other components of DOXIL/CAELYX or VELCADE- Treatment for a malignant condition, other than multiple myeloma, within the 5 years prior to enrollment; except for basal cell carcinoma of the skin, non-metastatic squamous cell carcinoma of the skin, or cervical cancer in situ within the past 5 years- Seropositive for HIV, or active hepatitis A, B, or C infection- Poorly controlled hypertension, diabetes mellitus or other serious medical or psychiatric conditions that could interfere with adherence to or completion of this study - Pregnant or breast-feeding - Currently enrolled in another clinical research study or less than 30 days since receiving treatment on a research study (patients participating in studies unrelated to their cancer may be enrolled after consultation with and approval by the sponsor)- Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.

The primary endpoint of this study is the time to progression (TTP) defined as the interval between the date of randomization and the date of disease progression or death due to progression. Subjects who die without documented progression will be censored at the date of their last evaluation. Subjects who are progression-free at the time of data cutoff for an analysis will be censored for TTP at the time of their last tumor assessment. The date of progressive disease (PD) will be determined as the date of the first indication of progression, e.g., sufficient elevation of M-protein, a new skeletal event, using the criteria of EBMT Relapse and Progressive Disease Criteria

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

Si
No

No
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

Si
Information no disponible en EudraCT

Information no disponible en EudraCT
No

Si

Centros participantes:

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

3
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:

20

Para estudios internacionales:

400
630

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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