Multiple MyelomaPhase 4NCT03173092
A Study of Ixazomib (NINLARO®) in Combination With Lenalidomide and Dexamethasone (IRD) for the Treatment of Participants With Multiple Myeloma (MM)
A Phase 4 study testing Ixazomib, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Takeda at 21 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Ixazomib, Lenalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 21 sitesUnited States
- Study dates
- 13 Nov 2017to 30 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 join
- 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.
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- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Los Angeles Cancer Network/(Formerly -Pacific Cancer Medical Center)
Anaheim, California, 92801-1824
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30303-001
Saint Agnes Hospital
Baltimore, Maryland, 21229
American Oncology Partners of Maryland P.A
Bethesda, Maryland, 20817
Central Care Cancer Center
Bolivar, Missouri, 65613
Tri-Health Cancer Institute-Medical Oncology and Hematology Westside
Cincinnati, Ohio, 45247
US Oncology Research
Colorado Springs, Colorado, 80907
Texas Oncology- Presbyterian Cancer Center Dallas
Dallas, Texas, 75231
Compassionate Care Research Group, Inc.
Fountain Valley, California, 92708
Comprehensive Cancer Center of Nevada
Henderson, Nevada, 89074
Investigator Clinical Research - Indiana
Indianapolis, Indiana, 46260-2082
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128
Woodlands Medical Specialists- Pensacola
Pensacola, Florida, 32503
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Texas Oncology-San Antonio Northwest
San Antonio, Texas, 78240
Innovative Clinical Research
Santa Ana, California, 92705
Millennium Physicians Association
Shenandoah, Texas, 77380-3256
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Willamette Valley Cancer Institute and Research Center - Springfield
Springfield, Oregon, 97477
Arizona Oncology Associates
Tucson, Arizona, 85704
Texas Oncology -Tyler
Tyler, Texas, 75702
About this study
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)
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.
Read the detailed 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.
- Conditions
- Multiple Myeloma
- Being tested
- Ixazomib, Lenalidomide, Dexamethasone
- Keywords
- Drug therapy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxazomibDrug
Also called NINLARO, MLN9708
Ixazomib capsules.
LenalidomideDrug
Lenalidomide capsules.
DexamethasoneDrug
Dexamethasone.
| Study group | Role | What they receive |
|---|---|---|
| Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Experimental | 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. Receives: Drug: Ixazomib; Drug: Lenalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS is defined as time from date of first administration of study drug regimen to date of first documentation of progressive disease (PD) based on local laboratory results and investigator's assessment using modified International Myeloma Working Group (IMWG) response criteria or death due to any cause, whichever occurs first.
Measured: From date of first study drug administration until disease progression or death due to any cause, whichever occurs first (Up to 2 years).
Secondary outcomes (6)
Percentage of Participants with Partial Response (PR), Very Good Partial Response (VGPR) and Complete Response (CR)
Response is based on investigator's assessment using modified IMWG criteria.
Measured: Day 1 of each cycle (every 28 days) until disease progression for up to 3 years.
Duration of Response
Duration of response is defined as the time from the date of first documentation of a PR or better to the date of first documentation of PD for responders.
Measured: Day 1 of each cycle (every 28 days) until disease progression for up to 3 years.
Duration of Treatment (DoT)
DoT is defined as the time from the date of the first administration of the study drug regimen (IRD) to the date of the last administration of any of the 3 study drugs in the regimen.
Measured: From the date of the first study drug administration to the date of the last administration of any of the 3 study drugs (Up to 3 years).
Duration of Ixazomib Therapy
Duration of ixazomib therapy is defined as the time from the date of the first administration of ixazomib therapy to the date of the last administration of ixazomib therapy.
Measured: From the date of the first ixazomib administration to the date of the last ixazomib administration (Up to 3 years).
Relative Dose Intensity (RDI) for Each Study Drug
RDI for each study drug is defined as 100*(Total amount of dose taken)/(Total prescribed dose of treated cycles), where total prescribed dose equals [dose prescribed at enrollment * number of prescribed doses per cycle * the number of treated cycles].
Measured: Up to 3 years
Duration of Proteasome Inhibitor Therapy
Duration of proteasome inhibitor therapy is defined as the time from the date of the first administration of bortezomib based therapy to the date of the last administration of the study drug (ixazomib).
Measured: Up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start13 Nov 2017
- Primary completion30 Mar 2026
- Study completion30 Mar 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173092
- Sponsor's protocol ID
- C16038
- Other IDs
- U1111-1192-7696
- Status last verified
- Apr 2026
- First submitted
- 30 May 2017
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Publications
Rifkin RM, Costello CL, Birhiray RE, Kambhampati S, Richter J, Abonour R, Lee HC, Stokes M, Ren K, Stull DM, Cherepanov D, Bogard K, Noga SJ, Girnius S. In-class transition from bortezomib-based therapy to IRd is an effective approach in newly diagnosed multiple myeloma. Future Oncol. 2024 Jan;20(3):131-143. doi: 10.2217/fon-2023-0272. Epub 2023 Oct 9.
PubMed 37807952
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03173092
- Acronym / sponsor ID
- C16038
- Conditions
- Multiple Myeloma
- Keywords
- Drug therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: All participants on the study have concluded treatment, core study activities are complete, and the scientific goals of the study have been met.
- Enrolment
- 141 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Experimental | Drug: Ixazomib, Drug: Lenalidomide, Drug: DexamethasoneIxazomib 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
- 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:
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IxazomibAlso: NINLARO, MLN9708Ixazomib capsules. | Drug | Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg |
| LenalidomideLenalidomide capsules. | Drug | Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg |
| DexamethasoneDexamethasone. | Drug | Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg |
Primary outcome
Progression Free Survival (PFS)
Time frame: From date of first study drug administration until disease progression or death due to any cause, whichever occurs first (Up to 2 years).
PFS is defined as time from date of first administration of study drug regimen to date of first documentation of progressive disease (PD) based on local laboratory results and investigator's assessment using modified International Myeloma Working Group (IMWG) response criteria or death due to any cause, whichever occurs first.
6 secondary outcomes
Percentage of Participants with Partial Response (PR), Very Good Partial Response (VGPR) and Complete Response (CR)
Time frame: Day 1 of each cycle (every 28 days) until disease progression for up to 3 years.
Duration of Response
Time frame: Day 1 of each cycle (every 28 days) until disease progression for up to 3 years.
Duration of Treatment (DoT)
Time frame: From the date of the first study drug administration to the date of the last administration of any of the 3 study drugs (Up to 3 years).
Duration of Ixazomib Therapy
Time frame: From the date of the first ixazomib administration to the date of the last ixazomib administration (Up to 3 years).
Relative Dose Intensity (RDI) for Each Study Drug
Time frame: Up to 3 years
Duration of Proteasome Inhibitor Therapy
Time frame: Up to 3 years.
Results and safety
The study was stopped early (reason given: All participants on the study have concluded treatment, core study activities are complete, and the scientific goals of the study have been met.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 37807952Rifkin RM, Costello CL, Birhiray RE, Kambhampati S, Richter J, Abonour R, Lee HC, Stokes M, Ren K, Stull DM, Cherepanov D, Bogard K, Noga SJ, Girnius S. In-class transition from bortezomib-based therapy to IRd is an effective approach in newly diagnosed multiple myeloma. Future Oncol. 2024 Jan;20(3):131-143. doi: 10.2217/fon-2023-0272. Epub 2023 Oct 9.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ixazomib, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Takeda at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: All participants on the study have concluded treatment, core study activities are complete, and the scientific goals of the study have been met.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: From date of first study drug administration until disease progression or death due to any cause, whichever occurs first (Up to 2 years).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03173092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.