A prospective phase I/II trial of the combination of ixazomib citrate, rituximab and dexamethasone in patients wit relapsed or rogressive Waldenström’s macroglobiulinemia. A HOVON / Greek Myeloma Study Group study
Completed
- Conditions
- Waldenström’s macroglobulinemia (WM)
- Registration Number
- NL-OMON27880
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data Center-CTCErasmus MC P.O. box 2040NL- 3000 CA RotterdamTel: +31 10 7041560Fax: +31 10 7041028e-mail: hdc@erasmusmc.nl
- Brief Summary
none
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 72
Inclusion Criteria
•A diagnosis of relapsed or progressive WM (lymphoplasmacytoid lymphoma in the bone marrow with an IgM M-protein)
•Age ≥ 18 years
Exclusion Criteria
•Bortezomib refractory (no PR/CR after treatment with bortezomib, and/or progression within 6 months of treatment with bortezomib)
•Rituximab refractory (progressive disease during treatment or within 6 months after last administration of rituximab)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: to assess the recommended phase II dose for the combination of oral ixazomib citrate and dexamethasone in patients with WM.<br /><br /><br><br>Phase II: to assess the efficacy (overall response rate) of ixazomib citrate in combination with rituximab and dexamethasone<br>
- Secondary Outcome Measures
Name Time Method