Phase
Condition
Bone Neoplasm
Lymphoproliferative Disorders
Cancer/tumors
Treatment
Ixazomib
Lenalidomide
Dexamethasone
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Must have a diagnosis of a MM using current IMWG diagnostic criteria and havereceived 1 prior line of therapy.
Participants must have completed 3 cycles of a bortezomib-based inductionregimen (as defined by current NCCN guidelines) and have no evidence of diseaseprogression as defined by IMWG criteria.
Participants with light chain and free light chain (FLC) only may be enrolledif they meet all the criteria for a diagnosis of MM.
Participants must be considered by their physician eligible to receiving theIRD regimen.
Must be transplant ineligible as determined by their physician, or if transplanteligible, not expect to undergo transplant for at least 24 months after studyenrollment. 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 otherperformance 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 ofcontraception, at the same time, from the time of signing the informed consentform through 90 days after the last dose of study drug, OR
Agree to practice true abstinence when this is in line with the preferred andusual lifestyle of the participant (periodic abstinence [example, calendar,ovulation, symptothermal, post-ovulation methods] and withdrawal are notacceptable 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 studytreatment 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 andusual lifestyle of the participant. (Periodic abstinence (example, calendar,ovulation, symptothermal, post-ovulation methods] and withdrawal are notacceptable methods of contraception).
Exclusion
Exclusion Criteria:
Participation in other interventional clinical trials, including those with otherinvestigational agents not included in this trial, within 30 days of the start ofthis 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 1toxicity) 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, 7days will be considered a sufficient interval between treatment and administrationof the ixazomib).
Central nervous system involvement by MM.
Infection requiring systemic antibiotic therapy or other serious infection within 14days before study enrollment.
Evidence of current uncontrolled cardiovascular conditions, including uncontrolledhypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heartfailure, unstable angina, or myocardial infarction within the past 6 months.
Systemic treatment, within 14 days before the first dose of ixazomib, with strongcytochrome P450 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin,carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John'swort.
Ongoing or active systemic infection, active hepatitis B or C virus infection, orknown human immunodeficiency virus positive.
Diagnosed or treated for another malignancy within 2 years before study enrollmentor previously diagnosed with another malignancy and have any evidence of residualdisease. Participants with nonmelanoma skin cancer or carcinoma in situ of any typeare not excluded if they have undergone complete resection.
Has greater than or equal to (>=) Grade 2 peripheral neuropathy, or Grade 1 withpain on clinical examination during the screening period.
Have previously been treated with ixazomib, or participated in a study with ixazomibwhether treated with ixazomib or not.
PD on first-line therapy.
Study Design
Study Description
Connect with a study center
Arizona Oncology Associates
Tucson, Arizona 85704
United StatesSite Not Available
Arizona Oncology Associates, P.C.
Tucson, Arizona 85704
United StatesSite Not Available
CARTI Cancer Center
Little Rock, Arkansas 72205
United StatesSite Not Available
Los Angeles Cancer Network/(Formerly -Pacific Cancer Medical Center)
Anaheim, California 92801-1824
United StatesSite Not Available
Pacific Cancer Medical Center
Anaheim, California 92801
United StatesSite Not Available
Compassionate Care Research Group, Inc.
Fountain Valley, California 92708
United StatesSite Not Available
Innovative Clinical Research
Santa Ana, California 92705
United StatesSite Not Available
The Oncology Institute of Hope & Innovation
Whittier, California 90603
United StatesSite Not Available
US Oncology Research
Colorado Springs, Colorado 80907
United StatesSite Not Available
Woodlands Medical Specialists - Pensacola
Pensacola, Florida 32503
United StatesSite Not Available
Woodlands Medical Specialists- Pensacola
Pensacola, Florida 32503
United StatesSite Not Available
Grady Memorial Hospital
Atlanta, Georgia 30303
United StatesSite Not Available
Winship Cancer Institute of Emory University
Atlanta, Georgia 30303-001
United StatesSite Not Available
Illinois Cancer Specialists - Niles
Niles, Illinois 60714
United StatesSite Not Available
American Health Network
Greenfield, Indiana 46140
United StatesSite Not Available
Hematology Oncology Of Indiana
Indianapolis, Indiana 46260
United StatesSite Not Available
Investigator Clinical Research - Indiana
Indianapolis, Indiana 46260-2082
United StatesSite Not Available
Oschner Medical Center
New Orleans, Louisiana 70121
United StatesSite Not Available
Saint Agnes Hospital
Baltimore, Maryland 21229
United StatesSite Not Available
American Oncology Partners of Maryland P.A
Bethesda, Maryland 20817
United StatesSite Not Available
Regional Cancer Care Associates
Bethesda, Maryland 20817
United StatesSite Not Available
Karmanos Cancer Institute
Bloomfield Hills, Michigan 48302
United StatesSite Not Available
Central Care Cancer Center
Bolivar, Missouri 65613
United StatesSite Not Available
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri 64128
United StatesSite Not Available
St. Vincent Frontier Cancer Center
Billings, Montana 59102
United StatesSite Not Available
Comprehensive Cancer Center of Nevada
Henderson, Nevada 89074
United StatesSite Not Available
Comprehensive Cancer Centers of Nevada
Henderson, Nevada 89052
United StatesSite Not Available
Regional Cancer Care Associates
East Brunswick, New Jersey 08816
United StatesSite Not Available
San Juan Oncology Associates
Farmington, New Mexico 87401
United StatesSite Not Available
Queens Medical Associates, PC
Fresh Meadows, New York 11366
United StatesSite Not Available
Clinical Research Alliance
New York, New York 11042
United StatesSite Not Available
Tri-Health Cancer Institute-Medical Oncology and Hematology Westside
Cincinnati, Ohio 45247
United StatesSite Not Available
TriHealth Cancer Institute - Medical Oncology and Hematology Westside
Cincinnati, Ohio 45247
United StatesSite Not Available
Louis Stokes Cleveland VA Medical Center - Wade Park Campus Location
Cleveland, Ohio 44106
United StatesSite Not Available
The Mark H. Zangmeister Cancer Center
Columbus, Ohio 43213
United StatesSite Not Available
Willamette Valley Cancer Institute and Research Center - Springfield
Springfield, Oregon 97477
United StatesSite Not Available
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United StatesSite Not Available
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United StatesSite Not Available
Veterans Affairs Tennessee Valley Healthcare System
Nashville, Tennessee 37212
United StatesSite Not Available
Texas Oncology - Austin Midtown
Austin, Texas 78705
United StatesSite Not Available
Texas Oncology - Presbyterian Cancer Center Dallas
Dallas, Texas 75231
United StatesSite Not Available
Texas Oncology- Presbyterian Cancer Center Dallas
Dallas, Texas 75231
United StatesSite Not Available
Texas Oncology - El Paso Cancer Treatment Center Grandview
El Paso, Texas 79902
United StatesSite Not Available
Cancer Center Associates
Mesquite, Texas 75150
United StatesSite Not Available
South Texas Veterans Health Care System
San Antonio, Texas 78229
United StatesSite Not Available
Texas Oncology - San Antonio Northwest
San Antonio, Texas 78240
United StatesSite Not Available
Texas Oncology-San Antonio Northwest
San Antonio, Texas 78240
United StatesSite Not Available
Millennium Physicians Association
Shenandoah, Texas 77380-3256
United StatesSite Not Available
Texas Oncology - Tyler
Tyler, Texas 75702
United StatesSite Not Available
Texas Oncology -Tyler
Tyler, Texas 75702
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.