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New drug cocktail aims to keep multiple myeloma in check

NCT ID NCT03173092

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether adding the drug ixazomib to lenalidomide and dexamethasone can help people with multiple myeloma stay in remission longer after their first round of chemotherapy. About 141 adults who had already completed 3 cycles of a bortezomib-based regimen took part. The goal was to see how long it took for the cancer to progress or for death to occur.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

141 people

The number who actually took part.

Started

Nov 2017

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. 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. 3. Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2 at time of enrollment. 4. 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). 5. 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). Exclusion Criteria: 1. 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. 2. Failure to have fully recovered (that is, less than or equal to \[\<=\] Grade 1 toxicity) 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, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib). 5. Central nervous system involvement by MM. 6. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment. 7. 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. 8. 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. 9. Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus positive. 10. 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. 11. Has greater than or equal to (\>=) Grade 2 peripheral neuropathy, or Grade 1 with pain on clinical examination during the screening period. 12. Have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not. 13. PD on first-line therapy.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

Contacts and locations

Locations

  • American Oncology Partners of Maryland P.A

    Bethesda, Maryland, 20817, United States

  • Arizona Oncology Associates

    Tucson, Arizona, 85704, United States

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105, United States

  • Central Care Cancer Center

    Bolivar, Missouri, 65613, United States

  • Compassionate Care Research Group, Inc.

    Fountain Valley, California, 92708, United States

  • Comprehensive Cancer Center of Nevada

    Henderson, Nevada, 89074, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Innovative Clinical Research

    Santa Ana, California, 92705, United States

  • Investigator Clinical Research - Indiana

    Indianapolis, Indiana, 46260-2082, United States

  • Kansas City Veterans Affairs Medical Center

    Kansas City, Missouri, 64128, United States

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

    Anaheim, California, 92801-1824, United States

  • Millennium Physicians Association

    Shenandoah, Texas, 77380-3256, United States

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229, United States

  • Texas Oncology -Tyler

    Tyler, Texas, 75702, United States

  • Texas Oncology- Presbyterian Cancer Center Dallas

    Dallas, Texas, 75231, United States

  • Texas Oncology-San Antonio Northwest

    San Antonio, Texas, 78240, United States

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

    Cincinnati, Ohio, 45247, United States

  • US Oncology Research

    Colorado Springs, Colorado, 80907, United States

  • Willamette Valley Cancer Institute and Research Center - Springfield

    Springfield, Oregon, 97477, United States

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30303-001, United States

  • Woodlands Medical Specialists- Pensacola

    Pensacola, Florida, 32503, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.