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
- Conditions
- Multiple Myeloma10018865
- Registration Number
- NL-OMON50234
- Lead Sponsor
- HOVO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 71
- 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 <75 years and WHO performance status
0-2 for patients * 75 years
- Absolute neutrophil count (ANC) * 1.0 x109/l and platelet count * 75x109/l ,
unless related to bone marrow infiltration by malignant plasmacells .
- Written informed consent.
- Patient gives consent for extra bone marrow and blood sampling.
- Negative pregnancy test at study entry or at least 1 year post-menopausal or
surgically sterile before study entry
- Patients must use adequate contraception as specified in the protocol (all
men and all women of childbearing potential)
- 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 <30 ml/min or Calculated Glomerular Filtration Rate
[ml/min/1.73m2] <30
- Systemic treatment, within 14 days before the first dose of ixazomib, with
strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine,
phenytoin, phenobarbital), or use of Ginkgo biloba or St. John*s wort.
- Pre-treatment with cytostatic drug, IMIDs or proteasome inhibitors.
Radiotherapy or a short course of steroids (e.g. 4 day treatment of
dexamethasone 40 mg/day or equivalent) are allowed. Radiotherapy should not be
given within 14 days before enrollment. In case of radiotherapy, if the
involved field is small, 7 days will be considered a sufficient interval
between treatment and administration of the ixazomib citrate
- Not able and/or not willing to use adequate contraception
- Female patients who are lactating or have a positive serum pregnancy test
during the screening period,
- Major surgery within 14 days before enrollment.
- Central nervous system involvement.
- Ongoing or active systemic infection, active hepatitis B or C virus
infection, or known human immunodeficiency virus (HIV) positive.
- Known GI disease or GI procedure that could interfere with the oral
absorption or tolerance of ixazomib citraat including difficulty swallowing.
- Diagnosed or treated for another malignancy within 2 years before study
enrollment or previously diagnosed with another malignancy and have any
evidence of residual disease. Patients with nonmelanoma skin cancer or
carcinoma in situ of any type are not excluded if they have undergone complete
resection.
- Participation in other clinical trials, including those with other
investigational agents not included in this trial, within 21days of the start
of this trial and throughout the duration of this trial.
- Any serious medical or psychiatric illness, or familial, sociological and
geographical condition potentially hampering compliance with the study protocol
and follow-up schedule
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Maintenance treatment<br /><br>- Progression free survival (PFS) from randomization, defined as time from<br /><br>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</p><br>
- Secondary Outcome Measures
Name Time Method