A RANDOMIZED, MULTICENTER, OPEN LABEL STUDY COMPARING TWO STANDARD TREATMENTS, BORTEZOMIB-MELPHALAN-PREDNISONE (VMP) VS LENALIDOMIDE-DEXAMETHASONE (Rd) IN AUTOLOGOUS STEM CELL TRANSPLANTATION (ASCT) INELIGIBLE COMMUNITY POPULATION AFFECTED BY MULTIPLE MYELOMA (MM)
- Conditions
- ewly diagnosed MM patients = 65 years old or ineligible for autologous stem cell transplantMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-004003-46-IT
- Lead Sponsor
- DIPARTIMENTO DI BIOTECNOLOGIE MOLECOLARI E SCIENZE PER LA SALUTE-UNIVERISITÀ DI TORINO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 350
- 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)<40 mL per minute or serum creatinine >2mg/dL
¿Anemia: hemoglobin valure of >20g/L below the lowest limit of normal, or a hemoglobin value <100g/L
¿Bone lesions: one or more osteolytic lesion on skeletal radiography, CT, or PET/CT. If bone marrow has <10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement
¿60% or greater clonal plasma cells on bone marrow examination
¿Serum involved/uninvolved free light chain ratio of 100 or greater
¿>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) < 40%
•FEV1 (forced expiratory volume-1 second) < 40%
•Bilirubin > 1.5 UNL, AST/ALT >2.5 UNL
•Creatinine clearance < 60 mL/min.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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 350
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method