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Multiple MyelomaPhase 2NCT02253316

Phase II Study of IRD (Ixazomib, Lenalidomide, Dexamethasone) Post Autologous Stem Cell Transplantation Followed by Maintenance Ixazomib or Lenalidomide for Multiple Myeloma

A Phase 2 study testing Ixazomib, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Washington University School of Medicine at 10 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this research study is to evaluate a treatment regimen called IRD which will be given to participants after their stem cell transplant in an effort to help prolong the amount of time the participants are disease-free after transplant. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Ixazomib, Lenalidomide and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
236 participants
Where
10 sitesUnited States
Study dates
20 Jan 2015to 31 Aug 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Each patient must meet all of the following inclusion criteria to begin IRD Consolidation:
  • Between the ages of 18 and 70 years of age (inclusive) at time of enrollment
  • Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
  • Confirmed diagnosis of symptomatic multiple myeloma. (Patients with multiple myeloma with secondary amyloidosis are eligible.)
  • Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within 2-16 months of the first dose of initial therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2
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  • Adequate organ function as defined below:
  • Absolute neutrophil count (ANC) >= 1,000 mm^3 Platelet count >= 75,000/mm^3; platelet transfusions to help patient meet eligibility criteria are not allowed within 7 days before study enrollment Total bilirubin <= 1.5 x upper limit of normal range (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3 x ULN Calculated creatinine clearance >= 30 mL/min
  • Women of childbearing potential must follow pregnancy testing requirements as outlined in the Revlimid REMS program material. This is defined as either committing to continued abstinence from heterosexual intercourse or beginning TWO acceptable methods of contraception (one highly effective method and one additional effective method AT THE SAME TIME) at least 28 days prior to the start of lenalidomide, for the duration of study participation, and for 28 days following the last dose of lenalidomide. Women of childbearing potential must also agree to ongoing pregnancy testing.
  • Men must agree to use a latex condom during sexual contact with a woman of childbearing potential even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
  • All study participants must be registered into the mandatory Revlimind REMS program and be willing to comply with its requirements. Per standard Revlimid REMS program requirements, all physicians who prescribe lenalidomide for research subjects enrolled into this trial, must be registered in, and must comply with, all requirements of the Revlimid REMS program.

Who cannot join

  • Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
  • Female patients who are lactating or have a positive serum pregnancy test during the screening period
  • Evidence of MM disease progression any time prior to enrollment. Progression from smoldering/asymptomatic MM to symptomatic MM is not exclusionary.
  • Tandem autologous transplantation
  • History of plasma cell leukemia or MM CNS involvement
  • Administration or planned administration of any other concomitant chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy which would be considered a treatment of multiple myeloma until Day +28 post-transplant through discontinuation from study. Patients may be on corticosteroids if they are being given for disorders other than multiple myeloma (e.g., adrenal insufficiency, rheumatoid arthritis, etc.)
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  • Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
  • Prior organ transplant requiring immunosuppressive therapy
  • Active hepatitis A, B or C virus infection, or known human immunodeficiency virus (HIV) positive
  • Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
  • Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib
  • Concurrent hematologic or non-hematologic malignancy requiring treatment (other than multiple myeloma and secondary amyloidosis)
  • Cardiac syncope, uncompensated NYHA Class 3 or 4 congestive heart failure, myocardial infarction within the previous six months, unstable angina pectoris, clinically significant repetitive ventricular arrhythmias despite antiarrhythmic treatment, severe orthostatic hypotension, or clinically important autonomic disease
  • Grade >= 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period
  • Major surgery within 14 days prior to enrollment
  • Infection requiring systemic antibiotic therapy or other serious infection within 14 days prior to enrollment
  • Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days prior to enrollment and throughout the duration of this trial

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Emory University - Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • City of Hope

    Duarte, California, 91010

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of California, San Francisco

    San Francisco, California, 94143

  • Washington University School of Medicine

    St Louis, Missouri, 62864

Other trials in United States

About this study

Official title: A Phase II Study of IRD (Ixazomib, Lenalidomide, & Dexamethasone) for Consolidation Therapy Post Autologous Stem Cell Transplantation Followed by Maintenance Ixazomib or Lenalidomide for Multiple Myeloma

The purpose of this research study is to evaluate a treatment regimen called IRD which will be given to participants after their stem cell transplant in an effort to help prolong the amount of time the participants are disease-free after transplant. IRD is a three-drug regimen consisting of ixazomib, lenalidomide (also called Revlimid), and dexamethasone. After 4 cycles of IRD, the participants will be randomized to receive maintenance therapy either with ixazomib or lenalidomide.

Read the detailed description

Based on the further need to improve progression-free survival and overall survival post-autologous stem cell transplantation (ASCT) for multiple myeloma and the benefits seen of consolidation/maintenance treatment with immunomodulatory drugs thalidomide and lenalidomide and the proteasome inhibitor bortezomib, the natural next step is to evaluate combination regimens of immunomodulatory drugs and proteasome inhibitors as consolidation/maintenance post-ASCT. The regimen consisting of ixazomib, lenalidomide, and dexamethasone (IRD) has been shown to have low toxicity, and the availability of an oral formulation of ixazomib allows for easier administration when compared to bortezomib.

In this study, following consolidation with IRD, patients will be randomized to maintenance therapy with lenalidomide or ixazomib in order to collect pilot data comparing the toxicity and efficacy of maintenance therapy with immunomodulatory drugs and proteasome inhibitors.

09/23/2019: Following interim analysis 3 performed in August 2019, patients who were still in screening or in the consolidation phase of the trial were allowed to proceed with the consolidation study treatment. Following completion of consolidation, all patients were enrolled into the lenalidomide arm with the exception of those who discontinued lenalidomide during the consolidation phase due to toxicity. Patients who discontinued lenalidomide were allowed to be enrolled into the ixazomib arm following approval from the site-specific principal investigator and study-wide principal investigator. For patients previously randomized to ixazomib maintenance and continuing treatment, the patient and the respective treating physician were allowed to determine if the patient should remain on ixazomib or transition to the lenalidomide arm. Patients who were previously on lenalidomide maintenance and transitioned onto ixazomib due to toxicity were allowed to continue ixazomib maintenance. Patients who were on lenalidomide maintenance were continued unaltered. Once patients transitioned out of maintenance (to either transition lenalidomide or transition ixazomib), the patients were only followed for safety.

09/30/2021: Following analysis 4 in 2021, the consensus agreement was to allow patients to continue ixazomib at the discretion of the treating physician and with patient consent after being informed of the trial data. Those that continued transition ixazomib were only followed for safety.

Being tested
Ixazomib, Lenalidomide, Dexamethasone
Keywords
Multiple Myeloma, Autologous Stem Cell Transplantation, Ixazomib, Lenalidomide, Dexamethasone
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IxazomibBiological

    Also called [14C]-ixazomib, [14C]-MLN9708

  • LenalidomideDrug

    Also called Revlimid

  • DexamethasoneDrug

    Also called Aeroseb-Dex, Alba-Dex, Decaderm, Decadrol

Study groups in NCT02253316
Study groupRoleWhat they receive
Consolidation: Ixazomib, Lenalidomide, & DexamethasoneExperimentalConsolidation therapy will begin between Day 80 and Day 120 following ASCT and will consist of four 28-day cycles of IRD (ixazomib, lenalidomide, \& dexamethasone). Barring dose modifications for toxicity, 4 mg of ixazomib and 40 mg of dexamethasone will be administered on Days 1, 8, and 15, and 15 mg of lenalidomide will be administered on daily on Days 1-21.
Receives: Biological: Ixazomib; Drug: Lenalidomide; Drug: Dexamethasone
Maintenance Arm 1: IxazomibExperimentalIxazomib will be administered on Days 1, 8, and 15 of a 28-day cycle at a starting dose of 4 mg until patient progresses or experiences an unacceptable toxicity.
Receives: Biological: Ixazomib
Maintenance Arm 2: LenalidomideExperimentalLenalidomide will be administered daily continuously for a 28-day cycle at a starting dose of 10 mg. If lenalidomide is tolerated well (i.e. no dose modification required) during the first three cycles, lenalidomide dose will be increased to 15 mg daily and will continue until patient progresses or experiences an unacceptable toxicity.
Receives: Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Improvement in Minimal Residual Disease (MRD)

    For the purposes of this study, a patient will be considered as having minimal residual disease if a positive result (1x10E06) is obtained using the Adaptive Clonoseq MRD testing.

    Measured: After 4 cycles of IRD consolidation treatment (approximately Day 112 of consolidation treatment)

Secondary outcomes (14)

  1. MRD-negative Rate After ASCT

    For the purposes of this study, a patient will be considered as having minimal residual disease if a positive result (1x10E06) is obtained using the Adaptive Clonoseq MRD testing

    Measured: Prior to beginning consolidation treatment (Day -28 to Day 0)

  2. Toxicity of IRD Consolidation

    For the purposes of this study, toxicity will be defined as inability to receive 4 cycles of IRD consolidation due to toxicity.

    Measured: After 4 cycles of IRD consolidation treatment (approximately Day 112 of consolidation treatment)

  3. Response Rate of IRD Consolidation

    For the purposes of this study, response rate is defined as the improvement in complete response rate. Response will be determined by the International Myeloma Working Group (IMWG) Uniform Response Criteria.

    Measured: After 4 cycles of IRD consolidation treatment (approximately Day 112 of consolidation treatment)

  4. Progression-free Survival of IRD Consolidation

    Progression-free survival (PFS) will be defined as time from ASCT to progression, relapse, or death, whichever occurs first, and those event-free survivors will be censored at withdrawal or study closeout.

    Measured: Up to 18 months after completion of maintenance therapy (Up to 5 years after starting the study)

  5. Overall Survival of IRD Consolidation

    Overall survival (OS) will be defined as time from ASCT to death due to any causes, and survivors will be censored at withdrawal or study closeout.

    Measured: Up to 18 months after completion of maintenance therapy (Up to 5 years after starting the study)

  6. Compare Toxicity Between the Two Maintenance Arms

    The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

    Measured: 30 days after the completion of maintenance treatment (estimated to be Day 1125 of maintenance treatment)

  7. Compare Response Rate Between the Two Maintenance Arms

    • Response will be determined by the International Myeloma Working Group (IMWG) Uniform Response Criteria. Response includes stringent complete response (sCR) and complete response (CR).
    • sCR requires all of the following:
    • CR as defined below
    • Normal free light chain ratio (0.26-1.65)
    • Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence
    • CR requires all of the following:
    • Disappearance of monoclonal protein by both protein electrophoresis and immunofixation studies from the blood and urine
    • If serum and urine monoclonal protein are unmeasurable, Normal free light chain ratio (0.26-1.65)
    • <5% plasma cells in the bone marrow
    • Disappearance of soft tissue plasmacytoma

    Measured: Through completion of maintenance treatment (estimated to be day 1095 of maintenance treatment)

  8. Compare Progression-free Survival Between the Two Maintenance Arms

    Progression-free survival (PFS) will be defined as time from ASCT to progression, relapse, or death, whichever occurs first, and those event-free survivors will be censored at withdrawal or study closeout.

    Measured: Up to 18 months after completion of maintenance therapy (Up to 5 years after starting the study)

  9. Compare Overall Survival Between the Two Maintenance Arms

    Overall survival (OS) will be defined as time from ASCT to death due to any causes, and survivors will be censored at withdrawal or study closeout.

    Measured: Up to 18 months after completion of maintenance therapy (Up to 5 years after starting the study)

  10. Rate of MRD-positive to MRD-negative Conversion Between the Two Maintenance Arms

    Measured: Cycle 13 Day 1 of maintenance treatment (Approximately Day 364 of maintenance treatment)

  11. Association of Progression-free Survival With MRD-negativity

    Progression-free survival (PFS) will be defined as time from ASCT to progression, relapse, or death, whichever occurs first, and those event-free survivors will be censored at withdrawal or study closeout.

    Measured: Up to 18 months after completion of maintenance therapy (Up to 5 years after starting the study)

  12. Association of Progression-free Survival With MRD-positivity

    Progression-free survival (PFS) will be defined as time from ASCT to progression, relapse, or death, whichever occurs first, and those event-free survivors will be censored at withdrawal or study closeout.

    Measured: Up to 18 months after completion of maintenance therapy (Up to 5 years after starting the study)

  13. Association of Overall Survival With MRD-negativity

    Overall survival (OS) will be defined as time from ASCT to death due to any causes, and survivors will be censored at withdrawal or study closeout.

    Measured: Up to 18 months after completion of maintenance therapy (Up to 5 years after starting the study)

  14. Association of Overall Survival With MRD-positivity

    Overall survival (OS) will be defined as time from ASCT to death due to any causes, and survivors will be censored at withdrawal or study closeout.

    Measured: Up to 18 months after completion of maintenance therapy (Up to 5 years after starting the study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2014 (estimated)
  2. Study start20 Jan 2015
  3. Primary completion5 Feb 2020
  4. Study completion31 Aug 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
236 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02253316
Sponsor's protocol ID
201411060
Status last verified
Oct 2026
First submitted
24 Sep 2014
Last updated
5 Nov 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ixazomib, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Washington University School of Medicine at 10 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 11 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Improvement in Minimal Residual Disease (MRD) (time frame: After 4 cycles of IRD consolidation treatment (approximately Day 112 of consolidation treatment)). 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 NCT02253316.

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 5 Nov 2026.

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