Multiple mieloma MedDRA version: 14.1 Level: PT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: VELCADE
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Bortezomib
Concentration unit: mg/m2 milligram(s)/square meter
Concentration number: 1.3-
Trade Name: S
Sponsors
ISTITUTO NAZIONALE PER LA CURA TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • age between 18 and 75 years old ; • written informed consent; • multiple myeloma at first active relapse; • Karnofsky performance status > 60%; • measurable disease: secretory MM defined as a serum monoclonal IgG of >= 1 g/dL or serum monoclonal IgA, IgD or IgE >= 0.5 g/dL or urine light-chain excretion of >200 mg/24 hours; • absolute neutrophil count >= 1000/microl, platelets > 75.000/microl; • no severe organ disfunctions; • life expectancy > 6 months. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • central nervous system localization; • pulmonary embolism in the last 3 months; • ongoing maintenance treatment with lenalinomide; • previous exposure to bortezomib and/or lenalidomide in the first line treatment, unless the patient has obtained at least a response >PR extended for >12 months; • grade 3-4 peripheral neuropathy; • any active, uncontrolled infection; • positive serologic markers for human immunodeficiency virus (HIV), active hepatitis B virus (HBV DNA positivity), and hepatitis C virus (HCV RNA positivity) infection; • Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study; • uncontrolled diabetes mellitus; • serum bilirubin levels > 2 the upper normal limit; • clearance of creatinine < 30 ml/min; • DLCO < 50%; • ejection fraction < 45% (or myocardial infarction in the last 12 months); • pregnancy or lactation; • patient not agreeing to take adequate contraceptive measures during the study, if at risk; • psychiatric disease; • active secondary malignancy; • inability to comply with medical therapy or follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In the present clinical study, we are planning to evaluate if the combination of bortezomib (Velcade)-cyclophosphamide-dexamethasone (VCD) is superior to the combination lenalidomide (Revlimid)-cyclophosphamide-dexamethasone (RCD) in MM patients with relapsed/refractory MM.The primary objective of this study is to compare the CR and VGPR rate at 6 weeks after the end of consolidation in patients treated with VCD versus RCD.;Secondary Objective: â?¢ Treatment-related mortality (TRM) â?¢ Progression free survival (PFS) â?¢ Time to treatment failure (TTF) â?¢ Treatment free interval (TFI) â?¢ Overall survival (OS) â?¢ Treatment discontinuation rate â?¢ Stringent CR â?¢ Phenotypic remission â?¢ Molecular remission â?¢ Comparison of bone marrow cytology and biopsy;Primary end point(s): The primary objective of this study is to compare the CR and VGPR rate at 6 weeks after the end of consolidation in patients treated with VCD versus RCD.;Timepoint(s) of evaluation of this end point: For the primary endpoint, the study will be concluded when the last enrolled patient will be observed for 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoint: • Treatment-related mortality (TRM) • Progression free survival (PFS) • Time to treatment failure (TTF) • Treatment free interval (TFI) • Overall survival (OS) • Treatment discontinuation rate • Stringent CR • Phenotypic remission • Molecular remission • Comparison of bone marrow cytology and biopsy;Timepoint(s) of evaluation of this end point: The efficacy of experimental therapy will be assessed during the experimental phase lasting for 3 years. Surviving patients will be included into an observational cohort and followed for 3 additional years to assess the long-term effect of experimental treatments on hard end-points like all-cause mortality as well as on secondary endpoints | — |
Countries
Italy
Contacts
Public ContactEmatologia TMO
fondazione IRCCS INT Milano
Outcome results
None listed