Hodgkin?s Lymphoma MedDRA version: 9.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: VELCADE*INIET 1FL 3,5MG 1MG/ML
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Bortezomib
Concentration unit: mg/ml milligram(s)/millilitre
Concentra
Sponsors
ISTITUTO CLINICO HUMANITAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of Hodgkin?s lymphoma failing or relapsing after first-line chemotherapy (MOPP/AVBD , MOPP/EBV/CAD and analogs are considered one line) Age >18 and 100 x 109/L, unless lower values are due to bone marrow-infiltration (in this case, platelet >50 x 109/L are admitted). - Hemoglobin >7.5 g/dL, with or without transfusion support we ask for 7.5 g/dL at baseline in our protocols - Absolute neutrophil count (ANC .1.5 x 109/L unless lower values are due to bone marrow-infiltration (in this case, ANC >0.75 x 109/L are admitted) - Serum calcium =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous treatment with velcade Patient has received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances including diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the incidence of complete remission as defined by PET-negativity, with the addition of bortezomib 1.3 mg/mq d 1,4 & 8 of each 21-day IGEV course.;Secondary Objective: The secondary objectives of this study are to determine the cumulative toxicity of the B-IGEV regimen, the freedom from progression and overall survival of patients treated with B-IGEV and high dose consolidation with PBSC support, and to retrospectively compare the activity of B-IGEV with current IGEV.;Primary end point(s): The primary objective is to evaluate the incidence of complete remission as defined by PET-negativity, with the addition of bortezomib 1.3 mg/mq d 1,4 & 8 of each 21-day IGEV course. | — |
Countries
Italy
Outcome results
None listed