(A Phase 2) STUDY TO DETERMINE THE EFFICACY AND SAFETY OF LENALIDOMIDE AND LOW-DOSE DEXAMETHASONE (Rd) FOLLOWED BY RITUXIMAB, AUTOGRAFT AND LENALIDOMIDE MAINTENANCE IN NEWLY DIAGNOSED WALDESTROM MACROGLOBULINEMIA SUBJECTS - ND
- Conditions
- Waldenstr?m`s MacroglobulinemiaMedDRA version: 9.1Level: LLTClassification code 10047801
- Registration Number
- EUCTR2010-020868-38-IT
- Lead Sponsor
- .O.C. EMATOLOGIA - OSP. S. EUGENIO - ASL RM C
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
• 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 < 1.5 mg/dL • AST and ALT < 2.5 x ULN • Disease free of prior malignancies fir 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast • Female patient is either post-menopausal for 24 consecutive months or surgically sterilized or agree to continuous abstinence from heterosexual sexual contact or willing to use two acceptable method of birth control at the same time (one highly effective method and one additional effective method) (Highly Effective Methods: Intrauterine device -IUD-; Hormonal -birth control pills, injections, implants-; tubal ligation; partner’s vasectomy; Additional Effective Methods: Latex condom; Diaphragm; Cervical Cap) for 4 weeks prior to beginning study drug therapy, during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of lenalidomide therapy. • Negative serum Beta-human chorionic gonadotropin (?Beta-HCG) pregnancy test both 24 hours prior to beginning of therapy and then at 4 weeks intervals in women with regular menstrual cycles or every 2 weeks in women with irregular menstrual cycles during study treatment for subjects of childbearing potential. • Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of lenalidomide therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
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) yes
F.1.3.1 Number of subjects for this age range
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method