PATIENTS WITH NEW DIAGNOSIS MM WITH AGE = 65 YEARS OR NOT ELIGIBLE TO ASCT
Conditions
Interventions
Product Name: CARFILZOMIB
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: NA
CAS Number: 868540-17-4
Current Sponsor code: NA
Other descriptive name: CARFILZOMIB
Concentrati
Sponsors
FO.NE.SA.Onlus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Newly diagnosed symptomatic MM based on either standard CRAB criteria (at least 10% of clonal bone marrow plasma cells plus CRAB defined as the onset of any of the following clinical symptoms: hypercalcemia, renal failure, anemia and bone lesions) or at least 10% of bone marrow plasma cells plus the presence of at least one of the following biomarkers of malignancy: ? 60% or greater clonal plasma cells on bone marrow examination; ? Serum involved/uninvolved free light chain (FLC) ratio of 100 or greater; ? More than one focal lesion on magnetic resonance imaging (MRI) that is at least 5 mm or greater in size. • Patient not eligible for ASCT (age = 65 years or abnormal cardiac, pulmonary and liver function). • Patient defined as fit or intermediate according to the IMWG (International Myeloma Working Group) frailty score • Patient has given voluntary written informed consent. • Patient agrees to use acceptable methods for contraception. • Patient has measurable disease according to IMWG criteria. • Patient has ECOG (Eastern Cooperative Oncology Group) performance status 50%) • Absolute neutrophil count (ANC) = 1 x 109/L without the use of growth factors • Corrected serum calcium =14 mg/dL (3.5 mmol/L) • Alanine transaminase (ALT): = 3 x the ULN • Total bilirubin: = 2 x the ULN • Calculated or measured creatinine clearance: = 30 mL/minute. • LVEF= 40%: 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation; multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available • Pre-treatment blood pressure value =65 years) yes F.1.3.1 Number of subjects for this age range 340
Exclusion criteria
Exclusion criteria: • Serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from the screening or place the subject at unacceptable risk. • Patient defined as frail according to the IMWG frailty score • Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid 140/90 mmHg) regardless treatment with 3 drugs, including a diuretic. • Contraindication to any of the required drugs or supportive treatments • Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib) • Invasive malignancy within the past 3 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the study regard the minimal residual disease (MRD) and the progression-free survival (PFS) of both treatment arms. The first primary objective is to determine the efficacy in term of MRD negativity (MRD after 2 years of treatment) in patients not eligible for ASCT, when carfilzomib is added to the association of lenalidomide-dexamethasone, and the second primary objective is the evaluation of PFS of both treatment arms.;Secondary Objective: Safety objectives: •To determine the incidence of dose reduction and drug discontinuation in both treatment arms; •To determine the benefit of proper cardiovascular baseline assessment and monitoring during treatment in both treatment arms •To determine the safety of both treatment arms. Efficacy objectives are the following: •To determine the response rate of both treatment arms; •To determine the PFS2 of both treatment arms; •To determine the time to progression (TTP) of both treatment arms; •To determine the duration of response (DOR) of both treatment arms; •To determine the overall survival (OS) of both treatment arms; •To determine the time to next therapy (TNT) of both treatment arms; •To determine the benefits of both treatment arms; •To determine the correlation between MRD negativity and PFS, PFS2, TTP, TNT and OS; •To determine difference of response and outcome in subgroups with different prognostic factors.;Primary end point(s): MRD (minimal residual disease);Timepoint(s) of evaluation of this end point: 5 YEARS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -PFS (PROGRESSION FREE SURVIVAL) -Response rate -PFS2 (PROGRESSION FREE SURVIVAL FROM SECOND LINE OF THERAPY) -TTP (time to progression) -DOR (duration of response) -TNT (time to next therapy) -Toxicity -Quality of life -Incidence of dose reduction and drug discontinuation in both treatment arms -Benefit of proper cardiovascular baseline assessment -MRD negativity -To determine difference of response and outcome in subgroups analysis with different prognostic factors;Timepoint(s) of evaluation of this end point: 5 YEARS | — |
Countries
Italy
Contacts
Public ContactClinical Trial Office
FO.NE.SA.Onlus
Outcome results
None listed