A Study of Ixazomib (NINLARO®) in Combination With Lenalidomide and Dexamethasone (IRD) for the T… (NCT03173092) | Clinical Trial Compass
TerminatedPhase 4
A Study of Ixazomib (NINLARO®) in Combination With Lenalidomide and Dexamethasone (IRD) for the Treatment of Participants With Multiple Myeloma (MM)
Stopped: All participants on the study have concluded treatment, core study activities are complete, and the scientific goals of the study have been met.
United States141 participantsStarted 2017-11-13
Plain-language summary
The main aim is to evaluate the effect of Ixazomib in combination with lenalidomide and dexamethasone on Multiple Myeloma disease progression at 2 years in participants who previously received a bortezomib-based induction regimen.
The study will enroll approximately 160 participants, who are enrolled after completing 3 cycles of chemotherapy (Bortezomib-Based Induction Regimen). They are then treated with Ixazomib in addition to lenalidomide and dexamethasone.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Must have a diagnosis of a MM using current IMWG diagnostic criteria and have received 1 prior line of therapy.
✓. Must be transplant ineligible as determined by their physician, or if transplant eligible, not expect to undergo transplant for at least 24 months after study enrollment.
✓. Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2 at time of enrollment.
✓. Female participants who:
✓. Male participants, even if surgically sterilized (that is, status post-vasectomy), must agree to one of the following:
Exclusion criteria
✕. Participation in other interventional clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial. Non-interventional trials (that is, observational trials) are permitted at any time point.
✕. Failure to have fully recovered (that is, less than or equal to \[\<=\] Grade 1 toxicity) from the reversible effects of prior chemotherapy.
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: From date of first study drug administration until disease progression or death due to any cause, whichever occurs first (Up to 2 years).
✕. Radiotherapy within 14 days before enrollment (if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib).
✕. Central nervous system involvement by MM.
✕. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment.
✕. 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.
✕. Systemic treatment, within 14 days before the first dose of ixazomib, with strong cytochrome P450 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort.