An Effectiveness and Safety Study of Ixazomib in Combination With Lenalidomide and Dexamethasone (IRD) in Participants With Multiple Myeloma Previously Receiving a Bortezomib-Based Triplet Induction Regimen

Overview

The drug being tested in this study is called Ixazomib. Ixazomib is being tested to treat people who have multiple myeloma (MM). This study will look at the effectiveness and safety in participants who take ixazomib in addition to lenalidomide and dexamethasone.

Participants will initially receive: Ixazomib 4 mg + lenalidomide 25 mg + dexamethasone 40 mg. Participants previously received a bortezomib-based triplet induction regimen, which included intravenous (IV) or subcutaneous (SC) bortezomib (biweekly or weekly) and IV or oral cyclophosphamide or oral lenalidomide and dexamethasone.

All participants will be asked to take ixazomib 4 mg on Days 1, 4 and 8 and lenalidomide 25 mg from Day 1 through 21 and dexamethasone 40 mg on Days 1, 4, 8 and 21 in 28 day cycles until disease progression or unacceptable toxicity for up to 2 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 36 months, including 12 months for enrollment, and a 24-month ixazomib in combination of lenalidomide and dexamethasone (IRD) treatment period (26 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.

SparkCures ID 925
Trial Phase Phase 4
Enrollment 160 Patients
Treatments
Trial Sponsors
  • Takeda Oncology
NCT Identifier

NCT03173092

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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.
  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.

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Arizona Oncology Associates PC Tucson - Rudasill - Medical Oncology

Tucson, AZ

Comprehensive Cancer Centers of Nevada (Henderson)

Henderson, NV

Texas Oncology San Antonio Northeast

San Antonio, TX

Cancer Center Associates

Mesquite, TX

Texas Oncology (Presbyterian Hospital)

Dallas, TX

Veterans Affairs Tennessee Valley Healthcare System

Nasvhille, TN

Willamette Valley Cancer Institute and Research Center RiverBend Pavilion in Springfield

Springfield, OR

TriHealth Cancer Institute (Westside)

White Oak, OH

Regional Cancer Care Associates

East Brunswick, NJ

Compassionate Cancer Care

Fountain Valley, CA

Kansas City VA Medical Center

Kansas City, MO

Central Care Cancer Center

Bolivar, MO

American Oncology Partners of Maryland, PA

Bethesda, MD

Saint Agnes Hospital Saint Agnes Healthcare

Baltimore, MD

Investigative Clinical Research Of Indiana, LLC

Indianapolis, IN

Woodlands Medical Specialists

Pensacola, FL

Innovative Clinical Research Institute

Whittier, CA

Texas Oncology

Tyler, TX

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

Pacific Cancer Medical Center Inc.

Anaheim, CA

Queens Medical Associates, PC

Fresh Meadows, NY

Clinical Research Alliance

Lake Success, NY

Cleveland VA Medical Center

Cleveland, OH

Avera Cancer Institute

Sioux Falls, SD

Millennium Physicians

Shenandoah, TX

Arizona
Arizona Oncology Associates PC Tucson - Rudasill - Medical Oncology

Tucson, AZ

California
Pacific Cancer Medical Center Inc.

Anaheim, CA

Compassionate Cancer Care

Fountain Valley, CA

Innovative Clinical Research Institute

Whittier, CA

Colorado
Florida
Woodlands Medical Specialists

Pensacola, FL

Indiana
Investigative Clinical Research Of Indiana, LLC

Indianapolis, IN

Maryland
Saint Agnes Hospital Saint Agnes Healthcare

Baltimore, MD

American Oncology Partners of Maryland, PA

Bethesda, MD

Missouri
Central Care Cancer Center

Bolivar, MO

Kansas City VA Medical Center

Kansas City, MO

Nevada
Comprehensive Cancer Centers of Nevada (Henderson)

Henderson, NV

New Jersey
Regional Cancer Care Associates

East Brunswick, NJ

New York
Queens Medical Associates, PC

Fresh Meadows, NY

Clinical Research Alliance

Lake Success, NY

Ohio
Cleveland VA Medical Center

Cleveland, OH

TriHealth Cancer Institute (Westside)

White Oak, OH

Oregon
Willamette Valley Cancer Institute and Research Center RiverBend Pavilion in Springfield

Springfield, OR

Pennsylvania
South Dakota
Avera Cancer Institute

Sioux Falls, SD

Tennessee
Veterans Affairs Tennessee Valley Healthcare System

Nasvhille, TN

Texas
Texas Oncology (Presbyterian Hospital)

Dallas, TX

Cancer Center Associates

Mesquite, TX

Texas Oncology San Antonio Northeast

San Antonio, TX

Millennium Physicians

Shenandoah, TX

Texas Oncology

Tyler, TX

Resources

There are no resources, links or videos to display for this clinical trial.