Phase II Study of combination Bortezomib, Dexamethasone, and Rituximab in previously untreated Patients with Waldenstrom?s Macroglobulinemia: A multicenter Trial of the European Myeloma Network - ND
- Conditions
- Waldenstrom macroglobulinemiaMedDRA version: 9.1Level: LLTClassification code 10047714Term: Von Waldenstrom macroglobulinaemia
- Registration Number
- EUCTR2006-003563-31-IT
- Lead Sponsor
- E.M.N. - EUROPEAN MYELOMA NETWORK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 61
Inclusion Criteria
- diagnosis of Waldenstrom macroglobulinemia - CD 20 positive disease - Karnowsky performance status >60 - PLT >50000/uL, neutrophils >750/uL - ALT <3 x url, bilirubin <2 x url - creatinine clearance >30 ML/min
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
Exclusion Criteria
- previous therapy for Waldenstrom macroglobulinemia - cardiac amyloidosis - peripheral neuropathy - pregnant or nursing women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the response rate [the combined complete response (CR) + partial response (PR) + minimal response (MR)] following treatment with BDR in patients with previously untreated WM.;Secondary Objective: To determine time to progression following treatment with BDR To assess the safety and tolerability of BDR in patients with WM.;Primary end point(s): - hematologic response
- Secondary Outcome Measures
Name Time Method