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

Last updated: March 16, 2026
Sponsor: Takeda
Overall Status: Active - Not Recruiting

Phase

4

Condition

Bone Neoplasm

Lymphoproliferative Disorders

Cancer/tumors

Treatment

Ixazomib

Lenalidomide

Dexamethasone

Clinical Study ID

NCT03173092
C16038
U1111-1192-7696
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Must have a diagnosis of a MM using current IMWG diagnostic criteria and havereceived 1 prior line of therapy.
  • Participants must have completed 3 cycles of a bortezomib-based inductionregimen (as defined by current NCCN guidelines) and have no evidence of diseaseprogression as defined by IMWG criteria.

  • Participants with light chain and free light chain (FLC) only may be enrolledif they meet all the criteria for a diagnosis of MM.

  • Participants must be considered by their physician eligible to receiving theIRD regimen.

  1. Must be transplant ineligible as determined by their physician, or if transplanteligible, not expect to undergo transplant for at least 24 months after studyenrollment. o Stem cell harvest and mobilization regimen is acceptable if clinically indicated,but must first be confirmed by the Takeda Medical Monitor.

  2. Eastern Cooperative Oncology Group (ECOG) performance status and/or otherperformance status 0, 1, or 2 at time of enrollment.

  3. 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 ofcontraception, at the same time, from the time of signing the informed consentform through 90 days after the last dose of study drug, OR

  • Agree to practice true abstinence when this is in line with the preferred andusual lifestyle of the participant (periodic abstinence [example, calendar,ovulation, symptothermal, post-ovulation methods] and withdrawal are notacceptable methods of contraception).

  1. 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 studytreatment 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 andusual lifestyle of the participant. (Periodic abstinence (example, calendar,ovulation, symptothermal, post-ovulation methods] and withdrawal are notacceptable methods of contraception).

Exclusion

Exclusion Criteria:

  1. Participation in other interventional clinical trials, including those with otherinvestigational agents not included in this trial, within 30 days of the start ofthis trial and throughout the duration of this trial. Non-interventional trials (that is, observational trials) are permitted at any time point.

  2. Failure to have fully recovered (that is, less than or equal to [<=] Grade 1toxicity) from the reversible effects of prior chemotherapy.

  3. Major surgery within 14 days before enrollment.

  4. Radiotherapy within 14 days before enrollment (if the involved field is small, 7days will be considered a sufficient interval between treatment and administrationof the ixazomib).

  5. Central nervous system involvement by MM.

  6. Infection requiring systemic antibiotic therapy or other serious infection within 14days before study enrollment.

  7. Evidence of current uncontrolled cardiovascular conditions, including uncontrolledhypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heartfailure, unstable angina, or myocardial infarction within the past 6 months.

  8. Systemic treatment, within 14 days before the first dose of ixazomib, with strongcytochrome P450 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin,carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John'swort.

  9. Ongoing or active systemic infection, active hepatitis B or C virus infection, orknown human immunodeficiency virus positive.

  10. Diagnosed or treated for another malignancy within 2 years before study enrollmentor previously diagnosed with another malignancy and have any evidence of residualdisease. Participants with nonmelanoma skin cancer or carcinoma in situ of any typeare not excluded if they have undergone complete resection.

  11. Has greater than or equal to (>=) Grade 2 peripheral neuropathy, or Grade 1 withpain on clinical examination during the screening period.

  12. Have previously been treated with ixazomib, or participated in a study with ixazomibwhether treated with ixazomib or not.

  13. PD on first-line therapy.

Study Design

Total Participants: 141
Treatment Group(s): 3
Primary Treatment: Ixazomib
Phase: 4
Study Start date:
November 13, 2017
Estimated Completion Date:
November 30, 2026

Study Description

The drug being tested in this study is called Ixazomib. Ixazomib is being tested to treat people who have MM. This study will look at the effectiveness and safety in participants who take the all-oral combination of ixazomib added to lenalidomide and dexamethasone.

The study will enroll approximately 160 participants. Participants will initially receive:

• Ixazomib 4 mg + lenalidomide 25 mg + dexamethasone 40 mg

Participants include MM participants who have received 3 cycles of a bortezomib-based induction regimen (as defined by current National Comprehensive Cancer Network [NCCN] guidelines) and have no evidence of PD following initial first-line therapy. All participants will be asked to take ixazomib 4 mg on Days 1, 8 and 15 and lenalidomide 25 mg from Day 1 through 21 and dexamethasone 40 mg on Days 1, 8, 15 and 22 in 28 day cycles until disease progression or unacceptable toxicity for up to 3 years.

Dose modifications of ixazomib, and/or lenalidomide and/or dexamethasone are allowed at the discretion of the physician.

This multi-center trial will be conducted in United States. It is anticipated that the treatment phase of this study will last up to 78 months, including 42 months for enrollment, and a 36-month IRD treatment period (39 cycles) with ixazomib and/or lenalidomide and/or dexamethasone for the last participant enrolled.

Participants will make multiple visits to the clinic as per their standard of care, and will be followed for PFS. After disease progression, participants will be followed-up for overall survival every 6 months until death or termination of the study by the sponsor.

Connect with a study center

  • Arizona Oncology Associates

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Arizona Oncology Associates, P.C.

    Tucson, Arizona 85704
    United States

    Site Not Available

  • CARTI Cancer Center

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Los Angeles Cancer Network/(Formerly -Pacific Cancer Medical Center)

    Anaheim, California 92801-1824
    United States

    Site Not Available

  • Pacific Cancer Medical Center

    Anaheim, California 92801
    United States

    Site Not Available

  • Compassionate Care Research Group, Inc.

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Innovative Clinical Research

    Santa Ana, California 92705
    United States

    Site Not Available

  • The Oncology Institute of Hope & Innovation

    Whittier, California 90603
    United States

    Site Not Available

  • US Oncology Research

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Woodlands Medical Specialists - Pensacola

    Pensacola, Florida 32503
    United States

    Site Not Available

  • Woodlands Medical Specialists- Pensacola

    Pensacola, Florida 32503
    United States

    Site Not Available

  • Grady Memorial Hospital

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia 30303-001
    United States

    Site Not Available

  • Illinois Cancer Specialists - Niles

    Niles, Illinois 60714
    United States

    Site Not Available

  • American Health Network

    Greenfield, Indiana 46140
    United States

    Site Not Available

  • Hematology Oncology Of Indiana

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Investigator Clinical Research - Indiana

    Indianapolis, Indiana 46260-2082
    United States

    Site Not Available

  • Oschner Medical Center

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Saint Agnes Hospital

    Baltimore, Maryland 21229
    United States

    Site Not Available

  • American Oncology Partners of Maryland P.A

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • Regional Cancer Care Associates

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Bloomfield Hills, Michigan 48302
    United States

    Site Not Available

  • Central Care Cancer Center

    Bolivar, Missouri 65613
    United States

    Site Not Available

  • Kansas City Veterans Affairs Medical Center

    Kansas City, Missouri 64128
    United States

    Site Not Available

  • St. Vincent Frontier Cancer Center

    Billings, Montana 59102
    United States

    Site Not Available

  • Comprehensive Cancer Center of Nevada

    Henderson, Nevada 89074
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Regional Cancer Care Associates

    East Brunswick, New Jersey 08816
    United States

    Site Not Available

  • San Juan Oncology Associates

    Farmington, New Mexico 87401
    United States

    Site Not Available

  • Queens Medical Associates, PC

    Fresh Meadows, New York 11366
    United States

    Site Not Available

  • Clinical Research Alliance

    New York, New York 11042
    United States

    Site Not Available

  • Tri-Health Cancer Institute-Medical Oncology and Hematology Westside

    Cincinnati, Ohio 45247
    United States

    Site Not Available

  • TriHealth Cancer Institute - Medical Oncology and Hematology Westside

    Cincinnati, Ohio 45247
    United States

    Site Not Available

  • Louis Stokes Cleveland VA Medical Center - Wade Park Campus Location

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • The Mark H. Zangmeister Cancer Center

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Willamette Valley Cancer Institute and Research Center - Springfield

    Springfield, Oregon 97477
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Veterans Affairs Tennessee Valley Healthcare System

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Texas Oncology - Austin Midtown

    Austin, Texas 78705
    United States

    Site Not Available

  • Texas Oncology - Presbyterian Cancer Center Dallas

    Dallas, Texas 75231
    United States

    Site Not Available

  • Texas Oncology- Presbyterian Cancer Center Dallas

    Dallas, Texas 75231
    United States

    Site Not Available

  • Texas Oncology - El Paso Cancer Treatment Center Grandview

    El Paso, Texas 79902
    United States

    Site Not Available

  • Cancer Center Associates

    Mesquite, Texas 75150
    United States

    Site Not Available

  • South Texas Veterans Health Care System

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Texas Oncology - San Antonio Northwest

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Texas Oncology-San Antonio Northwest

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Millennium Physicians Association

    Shenandoah, Texas 77380-3256
    United States

    Site Not Available

  • Texas Oncology - Tyler

    Tyler, Texas 75702
    United States

    Site Not Available

  • Texas Oncology -Tyler

    Tyler, Texas 75702
    United States

    Site Not Available

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