Under construction – not a live service
Sign in
TerminatedPhase 4

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

Key facts

Who runs it
Takeda
Where
Anaheim, Atlanta, Baltimore, Bethesda, Bolivar, Cincinnati, Colorado Springs, Dallas, Fountain Valley, Henderson, Indianapolis, Kansas City, Pensacola, Philadelphia, San Antonio, Santa Ana, Shenandoah, Sioux Falls, Springfield, Tucson, and Tyler, United StatesSee the 21 sites
Trial code
Status
Terminated
Phase
Phase 4
People taking part
141 people enrolled
Started
13 Nov 2017
Ended
30 Mar 2026
Type of study
Interventional
Treatments tested
  • Ixazomib
  • Lenalidomide
  • Dexamethasone
Record updated
4 May 2026
Why it stopped
All participants on the study have concluded treatment, core study activities are complete, and the scientific goals of the study have been met.

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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)
  • Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment
  • 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
  • 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
  • Have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not
  • PD on first-line therapy
  • 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
  • Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus positive
  • Central nervous system involvement by MM
  • Has greater than or equal to (>=) Grade 2 peripheral neuropathy, or Grade 1 with pain on clinical examination during the screening period

Where in United States

  • Los Angeles Cancer Network/(Formerly -Pacific Cancer Medical Center)Anaheim, United StatesNo longer taking part
  • Winship Cancer Institute of Emory UniversityAtlanta, United StatesNo longer taking part
  • Saint Agnes HospitalBaltimore, United StatesNo longer taking part
  • American Oncology Partners of Maryland P.ABethesda, United StatesNo longer taking part
  • Central Care Cancer CenterBolivar, United StatesNo longer taking part
  • Tri-Health Cancer Institute-Medical Oncology and Hematology WestsideCincinnati, United StatesNo longer taking part
  • US Oncology ResearchColorado Springs, United StatesNo longer taking part
  • Texas Oncology-Presbyterian Cancer Center DallasDallas, United StatesNo longer taking part
  • Compassionate Care Research Group, Inc.Fountain Valley, United StatesNo longer taking part
  • Comprehensive Cancer Center of NevadaHenderson, United StatesNo longer taking part
  • Investigator Clinical Research - IndianaIndianapolis, United StatesNo longer taking part
  • Kansas City Veterans Affairs Medical CenterKansas City, United StatesNo longer taking part
  • Woodlands Medical Specialists- PensacolaPensacola, United StatesNo longer taking part
  • Fox Chase Cancer CenterPhiladelphia, United StatesNo longer taking part
  • Texas Oncology-San Antonio NorthwestSan Antonio, United StatesNo longer taking part
  • Innovative Clinical ResearchSanta Ana, United StatesNo longer taking part
  • Millennium Physicians AssociationShenandoah, United StatesNo longer taking part
  • Avera Cancer InstituteSioux Falls, United StatesNo longer taking part
  • Willamette Valley Cancer Institute and Research Center - SpringfieldSpringfield, United StatesNo longer taking part
  • Arizona Oncology AssociatesTucson, United StatesNo longer taking part
  • Texas Oncology - TylerTyler, United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mgTreatment being tested

    Ixazomib 4 milligram (mg), capsules, orally, once, on Days 1, 8 and 15 and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22 of a 28-day cycle for a maximum of 39 cycles until PD or unacceptable toxicity, whichever occurs first for up to 3 years.

    Treatment: Ixazomib, Lenalidomide, and Dexamethasone

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
An Open-Label, Single-Arm, Multicenter Study to Evaluate the Effectiveness and Safety of Ixazomib (NINLARO®) in Combination With Lenalidomide and Dexamethasone (IRD) in Patients With Multiple Myeloma Previously Receiving a Bortezomib-Based Induction Regimen (US MM-6)
Record updated
4 May 2026