Waldenstr?m`s Macroglobulinemia MedDRA version: 9.1 Level: LLT Classification code 10047801
Conditions
Interventions
Trade Name: REVLIMID
Pharmaceutical Form: Capsule, hard
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Sponsors
U.O.C. EMATOLOGIA - OSP. S. EUGENIO - ASL RM C
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Clinico-pathological diagnosis of Waldenstrom`s macroglobulinemia using consensus panel criteria • Baseline staging requirements • Age from 18 to 75 years • CD20 positive based on any previous bone marrow immunohistochemistry or flow cytometric analysis • Measurable disease • ECOG performance status of 0-2 • Absolute neutrophil count = 1000/ul • Platelet count = 50000 /ul • Hemoglobin > 10 g/dL • Calculated or measured creatinine clearance: = 30 mL/minute • Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Chemotherapy, steroid therapy, or radiation therapy within 30 days of study entry • Concurrent use of other anti-cancer agents or treatments • Pregnant or lactating women • Serious co-morbid disease • Uncontrolled bacterial, fungal or viral infection • Active second malignancy • Development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the feasibility and antitumor activity of lenalidomide and low-dose dexamethasone, followed by rituximab as pre-transplant induction, in newly-diagnosed WM patients candidate to high-dose chemotherapy;Secondary Objective: To describe safety and tolerability;Primary end point(s): • Progression-free survival at 3 years (60%) | — |
Countries
Italy
Outcome results
None listed