Efficacy and tolerability of ixazomib, daratumumab and low dose dexamethasone (IDd) followed by ixazomib and daratumumab maintenance therapy until progression for a maximum of 2 years in unfit and frail newly diagnosed multiple myeloma patients; an open-label phase II trial
Completed
- Conditions
- Multiple Myeloma, unfit or frail patients, Ixazomib, Daratumumab
- Registration Number
- NL-OMON23842
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 132
Inclusion Criteria
•Previously untreated patients with a confirmed diagnosis of multiple myeloma according to IMWG criteria (see appendix A);
•Measurable disease according to the IMWG criteria;
(If plasmacytoma is the only measurable parameter, the patient is not allowed to be included in the study, because of difficult response evaluation)
Exclusion Criteria
•Non-secretory MM;
•Plasma cell leukemia;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method