MULTIPLE MYELOMA (MM) PATIENTS WHO EXPERIENCE BIOCHEMICAL (EARLY TREATMENT) OR CLINICAL RELAPSE (LATE TREATMENT) DURING LENALIDOMIDE MAINTENANCE TREATMENT MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: IMNOVID - 1 MG - CAPSULA RIGIDA - UDO ORALE - BLISTER (PVC/PCTFE) - 21 CAPSULE
Product Name: Pomalidomide
Product Code: [CC-4047]
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Po
Sponsors
Fondazione EMN Italy Onlus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients >18 years and 200 mg/24 hours; only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels must be >10 mg/dL.- Less than 10% of oligo- or non-secretory MM patients with free light chains will be admitted to this study in order to maximize interpretation of benefit results. • Patient receiving lenalidomide maintenance therapy as part of first line treatment (concomitant use of prednisone is accepted) and has experienced a biochemical relapse, with evidence of progressive disease defined as an increase of 25% from lowest response value in any one or more of the following: serum M-component (absolute increase must be =0.5 g/100 ml) and/or urine M-component (absolute increase must be =200 mg per 24 hours); only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels must be >10 mg/dL (17). • Patient who received as first line treatment a bortezomib-based therapy, including lenalidomide maintenance during the same line of therapy, can be included in the trial. • Patient has a life-expectancy > 3 months • Patient has not a currently active malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, and has not invasive malignancies within the past 5 years • No history of allergic reactions attributed to study agents • Patient has the following laboratory values within 28 days before baseline day 1 of the cycle 1: a) absolute neutrophil count (ANC) > 1 x 10^9/L b) platelet count > 75 x 10^9/L c) haemoglobin > 8 g/dl. d) aspartate transaminase (AST): =65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
Exclusion criteria: • Pregnant or lactating females. • Patient with Creatinine Clearance (CrCl) < 45 mL/minute • Patient with peripheral neuropathy = Grade 2 • Subject with any one of the following: • Congestive heart failure (NY Heart Association Class III or IV) • Myocardial infarction within 12 months prior to starting study treatment • Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris • Any significant medical disease or conditions (e.g. pulmonary disease, infection) that, in the investigator’s opinion, may interfere with protocol adherence or subject’s ability to give informed consent or could place the subject at unacceptable risk. • Clinical active infectious hepatitis type A, B, C or HIV. • Acute active infection requiring antibiotics or infiltrative pulmonary disease. • Contraindication to any of the required drugs or supportive treatments. • Known allergy to any of the study medications, their analogues, or excipients in the various formulations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: o Compare the efficacy of pom-dex versus pom-cyclo-dex in terms of OS o Evaluate the best treatment strategy (EARLY TREATMENT at biochemical relapse versus LATE TREATMENT at onset of CRAB symptoms/significant paraprotein increase) in terms of OS ;Secondary Objective: o Compare the best therapy, pom-dex vs pom-cyclo-dex in terms of PFS o Compare the best strategy, EARLY TREATMENT versus LATE TREATMENT, in terms of PFS2 o Evaluate quality of life (QoL) and health related costs in the two therapies, pom-dex versus pom-cyclo-dex, and in the two strategies, EARLY TREATMENT versus LATE TREATMENT. o Explore the presence of clinically meaningful interactions between therapies and strategies o Determine whether tumor response, PFS, PFS2 and OS might significantly change in particular subgroups of patients defined by prognostic factors (such as International Staging System, chromosomal abnormalities) and by performance status o Evaluate the safety and tolerability of the strategy and of the combination pom-dex and pom-cyclo-dex ;Primary end point(s): The primary endpoint for both comparisons is Overall Survival (OS), defined as the time from the date of random disclosure to the date of death from any cause;Timepoint(s) of evaluation of this end point: Timepoint of evaluation of this end point is at 5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to clinical progression, defined as the time from random assignment to the early or late strategy to the date of onset of CRAB symptoms or death. - PFS, defined as the time from random disclosure to the date of disease progression or death (16). - PFS2, defined as time from random disclosure to the date of disease progression while on the subsequent line of treatment or death from any cause (18). - Objective overall response rate - Quality of life, measured with EORTC-QLQ-C30 and QLQ-MY24 at baseline, every 2 months during the first year, and then every 6 months. - Health related costs - Incidence of hematologic and non-hematologic adverse events (AEs) ;Timepoint(s) of evaluation of this end point: Timepoint of evaluation of these end points is at 4 years. | — |
Countries
Italy
Contacts
Public ContactClinical Trial Office
Clinical Trial Office
Outcome results
None listed