Ixazomib citrate-thalidomide-low dose dexamethasone induction followed by maintenance therapy with ixazomib citrate or placebo in newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplantation; a randomized phase II trial.
Recruiting
- Conditions
- Multipel Myeloom, Ixazomib, elderly patients
- Registration Number
- NL-OMON29252
- Lead Sponsor
- Stichting HOVO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 142
Inclusion Criteria
Previously untreated patients with a confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria (see appendix A)
- Measurable disease according to the IMWG criteria (see appendix A)
Exclusion Criteria
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
- Systemic AL amyloidosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maintenance treatment<br /><br>- Progression free survival (PFS) from randomization, defined as time from randomization to progression or death from any cause, whichever comes first <br /><br>Induction treatment<br /><br>- Response rate defined as sCR, CR, VGPR or PR<br>
- Secondary Outcome Measures
Name Time Method - Safety and toxicity as defined by type, frequency and severity of adverse events as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4<br /><br>- PFS from registration<br /><br>- Overall survival (OS) from registration, measured until death from any cause. Patients alive will be censored at the date of last contact<br /><br>- OS from randomization.<br /><br>- Quality of response during maintenance, measured as improvement of response (from start maintenance till progression)<br /><br>- Time to maximum response, defined as time from registration to maximum response<br /><br>- Time to death from progression (after initial response), measured from time of first relapse/progression<br /><br>- Time to next treatment<br /><br>- PFS from the start of second line therapy<br /><br>- Quality of life as defined by the EORTC QLQ-C30 and QLQ-MY20 definitions.<br /><br>- Second Primary Malignancies<br>