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

NCT03433365 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2018-11-06

No results posted yet for this study

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.

Conditions

Interventions

OTHER

MRD analysis

To collect 2 samples for MRD analysis in patients treated with Lenalidomide

Sponsors & Collaborators

  • Fondazione EMN Italy Onlus

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2016-03-31
Completion
2017-08-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03433365 on ClinicalTrials.gov