Minimal residual disease monitoring in paztients with multiple myeloma that they have obtain a good response to the maintenance treatment with revlimid

LENALIDOMIDE MAINTENANCE IN MULTIPLE MYELOMA PATIENTS ACHIEVING AT LEAST VGPR AFTER INDUCTION THERAPY: MINIMAL RESIDUAL DISEASE MONITORING - MRD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004063-52-IT

Enrollment

Registered

2013-01-11

Start date

2013-03-21

Completion date

Unknown

Last updated

2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Multiple Myeloma in maintenance treatment with Lenalidomide MedDRA version: 14.1 Level: HLT Classification code 10028229 Term: Multiple myelomas System Organ Class: 100000004851

Interventions

Trade Name: REVLIMID*21CPS 25MG Pharmaceutical Form: Capsule, hard INN or Proposed INN: LENALIDOMIDE CAS Number: 191732-72-6 Concentration unit: mg milligram(s) Concentration type: up to Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patient has achieved at least a Very Good Partial Response before starting maintenance treatment - Availability of a bone marrow sample at diagnosed stored in the institution tissue bank to create patient-specific probes derived from IgH rearrangement Are the trial subjects under 18? yes Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ll

Design outcomes

Primary

Measure	Time frame
Main Objective: 1.To evaluate the activity of Lenalidomide on tumour load during maintenance phase analysing; 2.To verify whether molecular remissions obtained during maintenance therapy with Lenalidomide-based regimen are associated with a prolonged PFS.;Secondary Objective: 1. To verify whether MRD negativity obtained with Lenalidomide-based regimen maintenance is transient or persistent; 2. To verify whether molecular relapse always anticipates clinical relapse (MRD as early biomarker of relapse); 3. To investigate the role of MRD monitoring in peripheral blood compared with bone marrow; 4. To determine whether molecular remission is associated with longer Overall Survival.;Primary end point(s): 1.Rate of conversion from MRD positive to MRD negative during maintenance therapy; 2.Rate of patients with a reducing or increasing tumour load during therapy; 3.Rate of molecular relapse.;Timepoint(s) of evaluation of this end point: 3 years	—

Measure

Time frame

Main Objective: 1.To evaluate the activity of Lenalidomide on tumour load during maintenance phase analysing; 2.To verify whether molecular remissions obtained during maintenance therapy with Lenalidomide-based regimen are associated with a prolonged PFS.;Secondary Objective: 1. To verify whether MRD negativity obtained with Lenalidomide-based regimen maintenance is transient or persistent; 2. To verify whether molecular relapse always anticipates clinical relapse (MRD as early biomarker of relapse); 3. To investigate the role of MRD monitoring in peripheral blood compared with bone marrow; 4. To determine whether molecular remission is associated with longer Overall Survival.;Primary end point(s): 1.Rate of conversion from MRD positive to MRD negative during maintenance therapy; 2.Rate of patients with a reducing or increasing tumour load during therapy; 3.Rate of molecular relapse.;Timepoint(s) of evaluation of this end point: 3 years

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Secondary

Measure	Time frame
Secondary end point(s): 1. To verify wheter MRD negativity obtained with Lenalidomide-based regimen maintenance is transient or persistent 2. To verify wheter molecular relapse always anticipates clinical relapse (MRD as early biomarker of relapse) 3. To investigate the role of MRD monitoring in peripheral blood compared with bone marrow 4. To determine wheter molecular remmission is associated with longer OS;Timepoint(s) of evaluation of this end point: 3 years	—

Measure

Time frame

Secondary end point(s): 1. To verify wheter MRD negativity obtained with Lenalidomide-based regimen maintenance is transient or persistent 2. To verify wheter molecular relapse always anticipates clinical relapse (MRD as early biomarker of relapse) 3. To investigate the role of MRD monitoring in peripheral blood compared with bone marrow 4. To determine wheter molecular remmission is associated with longer OS;Timepoint(s) of evaluation of this end point: 3 years

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Countries

Italy

Contacts

Public ContactServizio informazione sperimentazio

Ufficio studi clinici

gismm2001@yahoo.com+390116336107

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026