Multiple Myeloma Clinical Trial
Official title:
Lenalidomide Maintenance in Multiple Myeloma Patients Achieving at Least VGPR After Induction Therapy: Minimal Residual Disease Monitoring
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.
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