A Study of Ixazomib (NINLARO®) in Combination With Lenalidomide and Dexamethasone (IRD) for the Treatment of Participants With Multiple Myeloma (MM)

Stopped early · Phase 4

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT03173092

Run by

Takeda

People needed

141

Starts

2017-11-13

Expected to finish

2026-03-30

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have a diagnosis of a MM using current IMWG diagnostic criteria and have received 1 prior line of therapy.
• Participants must have completed 3 cycles of a bortezomib-based induction regimen (as defined by current NCCN guidelines) and have no evidence of disease progression as defined by IMWG criteria.
• Participants with light chain and free light chain (FLC) only may be enrolled if they meet all the criteria for a diagnosis of MM.
• Participants must be considered by their physician eligible to receiving the IRD regimen.
• 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.
• o Stem cell harvest and mobilization regimen is acceptable if clinically indicated, but must first be confirmed by the Takeda Medical Monitor.
• Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2 at time of enrollment.
• Female participants who:
• Are postmenopausal for at least 1 year before the screening visit, OR
• Are surgically sterile, OR
• If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR
• Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence [example, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).
• Male participants, even if surgically sterilized (that is, status post-vasectomy), must agree to one of the following:
• Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
• Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence (example, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).

You may not qualify if…

• 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.
• Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus positive.
• 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. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
• Has greater than or equal to (>=) Grade 2 peripheral neuropathy, or Grade 1 with pain on clinical examination during the screening period.
• Have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not.
• PD on first-line therapy.

Where it is running

• Arizona Oncology Associates — Tucson, Arizona, United States
• Los Angeles Cancer Network/(Formerly -Pacific Cancer Medical Center) — Anaheim, California, United States
• Compassionate Care Research Group, Inc. — Fountain Valley, California, United States
• Innovative Clinical Research — Santa Ana, California, United States
• US Oncology Research — Colorado Springs, Colorado, United States
• Woodlands Medical Specialists- Pensacola — Pensacola, Florida, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• Investigator Clinical Research - Indiana — Indianapolis, Indiana, United States
• Saint Agnes Hospital — Baltimore, Maryland, United States
• American Oncology Partners of Maryland P.A — Bethesda, Maryland, United States
• Central Care Cancer Center — Bolivar, Missouri, United States
• Kansas City Veterans Affairs Medical Center — Kansas City, Missouri, United States
• Comprehensive Cancer Center of Nevada — Henderson, Nevada, United States
• Tri-Health Cancer Institute-Medical Oncology and Hematology Westside — Cincinnati, Ohio, United States
• Willamette Valley Cancer Institute and Research Center - Springfield — Springfield, Oregon, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Avera Cancer Institute — Sioux Falls, South Dakota, United States
• Texas Oncology- Presbyterian Cancer Center Dallas — Dallas, Texas, United States
• Texas Oncology-San Antonio Northwest — San Antonio, Texas, United States
• Millennium Physicians Association — Shenandoah, Texas, United States
• Texas Oncology -Tyler — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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