NCT03433365

Monitoring of Deep of Response During Lenalidomide Maintenance in MM Patients Achieving at Least Very Good Partial Response (MRD)

Lenalidomide Maintenance in Multiple Myeloma Patients Achieving at Least VGPR After Induction Therapy: Minimal Residual Disease Monitoring

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Fondazione EMN Italy Onlus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
OTHER	MRD analysis	To collect 2 samples for MRD analysis in patients treated with Lenalidomide

Timeline

• Start date: 2013-03-01
• Primary completion: 2016-03-01
• Completion: 2017-08-01
• First posted: 2018-02-14
• Last updated: 2018-11-06

Locations

1 site across 1 country: Italy