Spots Global Cancer Trial Database for A Study of Ixazomib (NINLARO®) in Combination With Lenalidomide and Dexamethasone (IRD) for the Treatment of Participants With Multiple Myeloma (MM)
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Trial Identification
Brief Title: A Study of Ixazomib (NINLARO®) in Combination With Lenalidomide and Dexamethasone (IRD) for the Treatment of Participants With Multiple Myeloma (MM)
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)
Study ID: NCT03173092
Conditions
Study Description
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.
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology Associates, P.C., Tucson, Arizona, United States
CARTI Cancer Center, Little Rock, Arkansas, United States
Pacific Cancer Medical Center, Anaheim, California, United States
Compassionate Care Research Group, Inc., Fountain Valley, California, United States
The Oncology Institute of Hope & Innovation, Whittier, California, United States
US Oncology Research, Colorado Springs, Colorado, United States
Woodlands Medical Specialists - Pensacola, Pensacola, Florida, United States
Grady Memorial Hospital, Atlanta, Georgia, United States
Illinois Cancer Specialists - Niles, Niles, Illinois, United States
American Health Network, Greenfield, Indiana, United States
Hematology Oncology Of Indiana, Indianapolis, Indiana, United States
Oschner Medical Center, New Orleans, Louisiana, United States
Saint Agnes Hospital, Baltimore, Maryland, United States
Regional Cancer Care Associates, Bethesda, Maryland, United States
Karmanos Cancer Institute, Bloomfield Hills, Michigan, United States
Central Care Cancer Center, Bolivar, Missouri, United States
Kansas City Veterans Affairs Medical Center, Kansas City, Missouri, United States
St. Vincent Frontier Cancer Center, Billings, Montana, United States
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
San Juan Oncology Associates, Farmington, New Mexico, United States
TriHealth Cancer Institute - Medical Oncology and Hematology Westside, Cincinnati, Ohio, United States
Willamette Valley Cancer Institute and Research Center - Springfield, Springfield, Oregon, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Veterans Affairs Tennessee Valley Healthcare System, Nashville, Tennessee, United States
Texas Oncology - Austin Midtown, Austin, Texas, United States
Texas Oncology - Presbyterian Cancer Center Dallas, Dallas, Texas, United States
Texas Oncology - El Paso Cancer Treatment Center Grandview, El Paso, Texas, United States
Cancer Center Associates, Mesquite, Texas, United States
South Texas Veterans Health Care System, San Antonio, Texas, United States
Texas Oncology - San Antonio Northwest, San Antonio, Texas, United States
Millennium Physicians Association, Shenandoah, Texas, United States
Texas Oncology - Tyler, Tyler, Texas, United States
Contact Details
Name: Study Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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