Multiple Myeloma
Conditions
Interventions
Induction treatment with Ixazomib, Thalidomide and Dexamethasone.
Following induction therapy half of the patients will receive 4 mg of Ixazomib
capsules as a maintenance therapy until progression an
Sponsors
HOVON
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Previously untreated patients with a confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria - 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). - Age * 66 years or patients * 65 years not eligible for ASCT - WHO performance status 0-3 for patients
Exclusion criteria
Exclusion criteria: - Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent - Systemic AL amyloidosis - Polyneuropathy, grade 3 or higher or grade 2 with pain on clinical examination during the screening period - Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months - Severe pulmonary dysfunction (Modified Medical Research Counsil dyspnea scale classification III-IV) - Significant hepatic dysfunction (total bilirubin * 1.5 x ULN or transaminases * 3 times normal level) except patients with Gilbert*s syndrome as defined by > 80% unconjugated bilirubin - Creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maintenance treatment - Progression free survival (PFS) from randomization, defined as time from randomization to progression or death from any cause, whichever comes first Induction treatment - Response rate defined as sCR, CR, VGPR or PR | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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 - PFS from registration - Overall survival (OS) from registration, measured until death from any cause. Patients alive will be censored at the date of last contact - OS from randomization. - Quality of response during maintenance, measured as improvement of response (from start maintenance till progression) - Time to maximum response, defined as time from registration to maximum response - Time to death from progression (after initial response), measured from time of first relapse/progression - Time to next treatment - PFS from the start of second line therapy - Quality of life as defined by the EORTC QLQ-C30 and QLQ-MY20 definitions. - Second Primary Malignancies | — |
Countries
Netherlands
Outcome results
None listed