This is an italian multicenter study to determine whether maintenance treatment with Lenalidomide-based regimen significantly increases the rate of molecular remission in patients achieving at least a VGPR after therapy with new drugs combination. No changing in the planned therapy will be made according to MRD results. A total of 70 patients with newly diagnosed MM who are 18 years of age or older and who meet all of the eligibility criteria may be enrolled in this study. Potential study subjects will sign an informed consent prior undergoing any study related procedure. Patients enrolled in this study will receive Lenalidomide-based regimen as maintenance therapy according to their previous decided therapeutic schedule. All consecutive patients treated with Lenalidomide-based regimen as maintenance therapy and with inclusion criteria will be asked to participate to this study. No additional drugs will be administrated for this study whose aim is to monitor the MRD on bone marrow aspirate and peripheral blood of patients during maintenance therapy with Lenalidomide-based regimen.
Patients entering the study will signed an informed consent and will undergo bone marrow aspiration and peripheral blood examination. On both these two tissues the MRD analysis reaching for myeloma cells. During the treatment period, all patients will attend study center visits every 4 weeks, until development of confirmed Progressive Disease (PD). During this visits the patients will undergo physical evaluation and routine blood control will be performed to monitor response to therapy and side effects. When a patient develops a PD requiring the beginning of a new treatment, the patient interrupts the MRD monitoring but will be followed for survival every 2 months via telephone or office visit.
Study Type
OBSERVATIONAL
Enrollment
70
To collect 2 samples for MRD analysis in patients treated with Lenalidomide
AOU Città della Salute e della Scienza di Torino
Torino, Italy
MRD conversion
Rate of conversion from MRD positive to MRD negative during maintenance therapy (qualitative PCR approach)
Time frame: 2 years
Tumour load
Rate of patients with a reducing or increasing tumour load during therapy (quantitative real time PCR approach)
Time frame: 2 years
Molecular relapse
Rate of molecular relapse
Time frame: 2 years
MRD negativity
MRD negativity duration during lenalidomide maintenance treatment
Time frame: 2 years
Molecular relapse
Time from diagnosis to molecular relapse. Evaluate if molecular relapse can be considered an early biomarker of relapse
Time frame: 2 years
Peripheral blood compared with bone marrow
Evaluate MRD negativity on peripheral blood samples and compare it with MRD analysis conducted on bone marrow samples
Time frame: 2 years
Overall Survival
Time from diagnosis to death in patients who achieved a molecular remission. Compare these results with the overall population
Time frame: 2 years
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