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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — do you know why it was stopped, and does that affect whether ixazomib with lenalidomide and dexamethasone is still considered a viable option for my situation?
2Since this was a Phase 4 study measuring progression-free survival, what do the results from this trial and other completed studies actually show about how long people with multiple myeloma typically respond to this three-drug combination before the disease progresses?
3Because the trial is no longer recruiting, could I still access ixazomib combined with lenalidomide and dexamethasone outside of a clinical trial, and would that be appropriate for my stage of multiple myeloma?
4Are there other active clinical trials or standard treatment regimens you would recommend comparing against this combination, especially given that this study was terminated and may not have generated complete safety and efficacy data?
5How would the demands of this three-drug regimen — including the oral ixazomib, lenalidomide, and dexamethasone schedule — fit into my daily life, and what side effects should I be most prepared to discuss before deciding on any treatment path?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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).
. 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.
. Major surgery within 14 days before enrollment.
. 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.