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

NCT03173092 | Terminated Phase 4 FDA Drug

• 2 other identifiers: C16038U1111-1192-7696
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 21

Brief 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.

Conditions

Multiple Myeloma

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Day 1 of each cycle (every 28 days) until disease progression for up to 3 years.

• Duration of Response

  Day 1 of each cycle (every 28 days) until disease progression for up to 3 years.

• Duration of Treatment (DoT)

  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

  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

  Up to 3 years

Study Arms (1)

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.

Drug: Ixazomib; Drug: Lenalidomide; Drug: Dexamethasone

Interventions

Ixazomib DRUG

Ixazomib capsules.

Also known as: NINLARO, MLN9708

Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg

Lenalidomide DRUG

Lenalidomide capsules.

Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg

Dexamethasone DRUG

Dexamethasone.

Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (21)

Arizona Oncology Associates

Tucson, Arizona, 85704, United States

Location

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

Anaheim, California, 92801-1824, United States

Location

Compassionate Care Research Group, Inc.

Fountain Valley, California, 92708, United States

Location

Innovative Clinical Research

Santa Ana, California, 92705, United States

Location

US Oncology Research

Colorado Springs, Colorado, 80907, United States

Location

Woodlands Medical Specialists- Pensacola

Pensacola, Florida, 32503, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30303-001, United States

Location

Investigator Clinical Research - Indiana

Indianapolis, Indiana, 46260-2082, United States

Location

Saint Agnes Hospital

Baltimore, Maryland, 21229, United States

Location

American Oncology Partners of Maryland P.A

Bethesda, Maryland, 20817, United States

Location

Central Care Cancer Center

Bolivar, Missouri, 65613, United States

Location

Kansas City Veterans Affairs Medical Center

Kansas City, Missouri, 64128, United States

Location

Comprehensive Cancer Center of Nevada

Henderson, Nevada, 89074, United States

Location

Tri-Health Cancer Institute-Medical Oncology and Hematology Westside

Cincinnati, Ohio, 45247, United States

Location

Willamette Valley Cancer Institute and Research Center - Springfield

Springfield, Oregon, 97477, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Texas Oncology- Presbyterian Cancer Center Dallas

Dallas, Texas, 75231, United States

Location

Texas Oncology-San Antonio Northwest

San Antonio, Texas, 78240, United States

Location

Millennium Physicians Association

Shenandoah, Texas, 77380-3256, United States

Location

Texas Oncology -Tyler

Tyler, Texas, 75702, United States

Location

Related Publications (1)

• 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.

  PMID: 37807952 DERIVED

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MeSH Terms

Conditions

Multiple Myeloma

Interventions

ixazomib; Lenalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 1, 2017
• Study Start: November 13, 2017
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (21)