Newly diagnosed MM patients = 65 years old or ineligible for autologous stem cell transplant MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: VELCADE - 1 FLACONCINO DA 3.5 MG
Product Name: Velcade
Product Code: [Velcade]
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: BORTEZOMIB
Current Sponsor code:
Sponsors
DIPARTIMENTO DI BIOTECNOLOGIE MOLECOLARI E SCIENZE PER LA SALUTE-UNIVERISITÀ DI TORINO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients has given voluntary written informed consent before the performance of any study related procedure; - Patients with newly diagnosed symptomatic multiple myeloma (NDMM) based on standard IMWG (International Myeloma Working Group) criteria (Appendix 12.2): • Clonal bone marrow plasma cells =10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following CRAB features and myeloma-defining events: ¿ Hypercalcemia: serum calcium >0.25 mmol/L (>1mg/dL) higher than the upper limit of normal or >2.75 mmol/L (>11mg/dL) ¿ Renal insufficiency: creatinine clearance (CLcr)2mg/dL ¿ Anemia: hemoglobin valure of >20g/L below the lowest limit of normal, or a hemoglobin value 1 focal lesion (=5 mm each) detected by MRI (magnetic resonance imaging) studies - According to physician’s opinion, patients can undergo either one of the two standard treatments and procedures; - Females of childbearing potential (FBCP) must use an effective method for 28 days before the study treatment, during the treatment and for at least 3 months after the last dose of study drugs; - Male subjects must use an effective barrier method if sexually active with FCBP during treatment and for at least 3 months after the last dose of study drug; - Patients should be ineligible for ASCT, defined as: - = 65 years old - younger than 65 years but - with abnormal cardiac, pulmonary, hepatic and renal function defined as [1]: • LVEF (left ventricular ejection fraction) 1.5 UNL, AST/ALT >2.5 UNL • Creatinine clearance =65 years) yes F.1.3.1 Number of subjects for this age range 350
Exclusion criteria
Exclusion criteria: - Hypersensitivity to any active substance or to any of the excipients (lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, boron, mannitol, nitrogen, crospovidone, colloidal anhydrous silica, hypromellose, titanium dioxide, macrogol, talc, sodium starch glycolate, sodium benzoate, propylene glycol, sodium dihydrogen phosphate, hydroxypropyl beta cyclodextrin, sodium saccharin, sodium EDTA, sodium hydroxide); - Pregnant and lactating women; - FBCP that do not follow the Pregnancy Prevention Plan requirements; - Acute diffuse infiltrative pulmonary and pericardial disease; - Acute viral infections (e.g. herpes simplex or ocular herpes simplex, herpes zoster, varicella); - Systemic mycotic or bacterial infections, unless specific anti-infectious therapy is ongoing; - Peptic ulcer; - Psychosis; - Administration of prophylactic vaccine from 8 to 2 weeks before starting treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the progression-free survival (PFS) of bortezomib-melphalan-prednisone (VMP) regimen vs lenalidomide-dexamethasone (Rd) treatment in real life, in unselected patient population.;Secondary Objective: ¿To compare the overall response rate (ORR) between the VMP and Rd arms ¿To compare the duration of response (DOR) between the VMP and Rd arms ¿To compare the overall survival (OS) between the VMP and Rd arms ¿To compare the progression-free survival 2 (PFS2) between the VMP and Rd arms ¿To compare the time to next therapy (TNT) between the VMP and Rd arms ¿To compare the time to progression (TTP) between the VMP and Rd arms ¿To compare safety in terms of incidence of hematologic and non-hematologic adverse events between the VMP and Rd arms ¿To compare the rate of treatment discontinuation or death for toxicity between VMP and Rd arms ¿To validate frailty score in a real life population, using geriatric assessment and considering patients¿ non-Myeloma polydrug therapies ¿To compare Quality of Life (QoL) between VMP and Rd arms ¿To compare direct health related costs and indirect costs between VMP and Rd arms ¿To evaluate the risk of infectious complications between VMP and Rd arms;Primary end point(s): Progression-free survival (PFS) of bortezomib-melphalan-prednisone (VMP) regimen vs lenalidomide-dexamethasone (Rd) treatment in real life, in unselected patient population.;Timepoint(s) of evaluation of this end point: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To determine the overall response rate (ORR) within the VMP and Rd arms.; To determine the duration of response (DOR) within the VMP and Rd arms; To determine the overall survival (OS) within the VMP and Rd arms; To determine the progression-free survival 2 (PFS2) within the VMP and Rd arms; To determine the time to next therapy (TNT) within the VMP and Rd arms; To determine the time to progression (TTP) within the VMP and Rd arms; To evaluate safety in terms of incidence of hematologic and non-hematologic adverse events within the VMP and Rd arms; To assess the rate of treatment discontinuation or death for toxicity within the VMP and Rd arms; To assess the Quality of Life (QoL) of enrolled patients; To compare health related costs; Validation of frailty score will be made by estimating efficacy and safety endpoints in patients stratified according to Myeloma Frailty Scor and by considering patients¿ non-Myeloma polydrug therapies; Infectious risk complications will be evaluated in terms of incidence, severity, type of infection, need for hospitalization, deferral or suspension of study treatment with possible impact on PFS;Timepoint(s) of evaluation of this end point: 5 years; 5 years; 5 years; 5 years; 5 years; 5 years; 5 years; 5 years; 5 years; 5 years; 5 years; 5 years | — |
Countries
Italy
Contacts
Public ContactClinical Trial Office
DIPARTIMENTO DI BIOTECNOLOGIE MOLECOLARI E SCIENZE PER LA SALUTE-UNIVERISIT¿ DI TORINO
Outcome results
None listed