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
- Conditions
- immunocytomalymphoplasmacytic lymphomaWaldenstroms Macroglobulinemia10018865
- Registration Number
- NL-OMON30654
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 5
Clinicopathological diagnosis of Waldenstrom*s macroglobulinemia as defined by consensus panel one of the Second International Workshop on Waldenstrom*s macroglobulinemia. All patients with the diagnosis of WM will be evaluable for response according to the response criteria.
No prior systemic treatment for WM. Prior plasmapheresis to control hyperviscosity, is allowed.
Prior systemic treatment with WM (plasmapheresis is allowed)
Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
Patient has hypersensitivity to dexamethasone, bortezomib, boron or mannitol.
Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Cardiac amyloidosis.
Peripheral neuropathy or neuropathic pain grade 2 or higher as defined by NCI CTCAE version 3.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary efficity parameters are the lab. results in comparison with the<br /><br>baseline result.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Number of adverse events and side effects.</p><br>