Skip to main content

Testing the Addition of Ixazomib to Lenalidomide in Patients with Evidence of Residual Multiple Myeloma, OPTIMUM Trial

Trial Status: Active

This phase III trial studies how well lenalidomide in combination with ixazomib works compared to lenalidomide alone in treating patients with evidence of residual multiple myeloma after stem cell transplantation. Lenalidomide may help shrink or slow the growth of multiple myeloma. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide and ixazomib together may work better than giving lenalidomide alone in treating patients with evidence of residual multiple myeloma after a stem cell transplantation.

Inclusion Criteria

  • STEP 0: PRE-REGISTRATION
  • Patient must be previously diagnosed with multiple myeloma (MM) and be on lenalidomide maintenance with >= 10mg daily dose (>= 5 mg for patients with creatinine clearance 30-60 mL/min) for at least 10 months and no more than 15 months after an early autologous stem cell transplantation (SCT =< 12 months of diagnosis). Patient must not be off lenalidomide maintenance therapy for more than 30 days prior to start of treatment on Step 1 of this protocol
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • Patients must be able to undergo a diagnostic bone marrow aspirate following registration to Step 0 * NOTE: A bone marrow aspirate specimen must be submitted to Mayo Clinic Hematology Laboratory for central assessment of minimal residual disease (MRD) status to confirm patient’s eligibility for Step 1 randomization. Mayo Clinic will forward results =< within three (3) business days of receipt of the bone marrow specimen to the submitting institution
  • Patients must not have primary refractory or progressive disease on a proteasome inhibitor-based regimen during induction therapy prior to stem cell transplant
  • Patients must not be on other concurrent chemotherapy, or any ancillary therapy considered investigational * NOTE: Bisphosphonates are considered to be supportive care rather than therapy and are allowed while on protocol treatment
  • Patients must not have uncontrolled psychiatric illness or social situations that would limit compliance with study requirements
  • Patients must not have another malignancy requiring treatment or have received treatment within 2 years before pre-registration or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
  • Patients must have been able to maintain at least 10 mg dose of lenalidomide without growth factor support (at least 5 mg for patients with creatinine clearance 30-60 mL/min)
  • Patients must not have known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib or lenalidomide including difficulty swallowing
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • Patients must not have known hepatitis B surface antigen-positive status or known or suspected active hepatitis C infection, but testing specifically for the trial is not required
  • STEP 1 RANDOMIZATION
  • Patient must meet Step 0 eligibility criteria at the time of Step 1 randomization
  • Patient must not be off lenalidomide maintenance therapy for more than 30 days prior to start of treatment on Step 1 of this protocol
  • Patients must have evidence of residual disease by central MRD testing or by presence of monoclonal protein in serum or urine
  • Serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum free light chain (FLC) performed =< 28 days prior to randomization * NOTE: UPEP (on a 24-hour collection) is required, no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is >= 200 mg/24 hour (hr). Please note that if both serum and urine M-components are present, both must be followed in order to evaluate response
  • Hemoglobin >= 8 g/dL (obtained =< 14 days prior to randomization)
  • Untransfused platelet count >= 75,000 cells/mm^3 (obtained =< 14 days prior to randomization)
  • Absolute neutrophil count >= 1000 cells/mm^3 (obtained =< 14 days prior to randomization)
  • Calculated creatinine clearance >= 30 mL/min (obtained =< 14 days prior to randomization)
  • Total bilirubin =< 1.5 times the upper limit of normal (obtained =< 14 days prior to randomization)
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) and serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 times the upper limit of normal (obtained =< 14 days prior to randomization)
  • Patients must not have grade 2 or higher peripheral neuropathy or grade 1 peripheral neuropathy with pain per CTCAE
  • Patients must not have uncontrolled intercurrent illness
  • Patients must not have grade 2 or higher diarrhea per CTCAE in the absence of antidiarrheals
  • Patients must not have been on systemic treatment, within 14 days before the first dose of ixazomib, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort
  • Patient must agree to register into the mandatory Revlimid Risk Evaluation and Mitigation Strategies (REMS) program and be willing and able to comply with the requirements of Revlimid REMS
  • Patient must not be pregnant due to potential harm to the fetus from ixazomib and lenalidomide. All patients of childbearing potential must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to the first dose of lenalidomide and again within 24 hours prior to the first dose of lenalidomide. Patients of childbearing potential must also agree to ongoing pregnancy testing while on treatment. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Patients of childbearing potential must either abstain from sexual intercourse for the duration of their participation in the study or agree to use TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting study treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 90 days after the last dose of protocol treatment. Patients must also agree to not breastfeed during this same time period. Men must agree to either abstain from sexual intercourse for the duration of their participation in the study or use a latex condom during sexual contact with a partner of childbearing potential while participating in the study and for 90 days after the last dose of protocol treatment even if they have had a successful vasectomy. Patients must also agree to abstain from donating sperm while on study treatment and for 28 days after the last dose of protocol treatment even if they have had a successful vasectomy. All patients must agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment

Arizona

Phoenix
Cancer Center at Saint Joseph's
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 602-406-0777

Arkansas

Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 855-313-2409

California

Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 805-219-4673
San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 805-219-4673
Santa Maria
Mission Hope Medical Oncology - Santa Maria
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 805-219-4673

Colorado

Colorado Springs
Penrose-Saint Francis Healthcare
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 719-776-6550
Rocky Mountain Cancer Centers-Penrose
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 719-776-6550
Denver
Porter Adventist Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 719-776-6550
Durango
Mercy Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 719-776-6550
Southwest Oncology PC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 719-776-6550
Lakewood
Saint Anthony Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 719-776-6550
Littleton
Littleton Adventist Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 719-776-6550
Longmont
Longmont United Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 719-776-6550
Rocky Mountain Cancer Centers-Longmont
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 719-776-6550
Parker
Parker Adventist Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 719-776-6550
Pueblo
Saint Mary Corwin Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 719-776-6550

Illinois

Aurora
Rush - Copley Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 630-978-6212
Bloomington
Illinois CancerCare-Bloomington
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Canton
Illinois CancerCare-Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Carbondale
Memorial Hospital of Carbondale
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 618-457-5200
Carterville
SIH Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 618-985-3333
Carthage
Illinois CancerCare-Carthage
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Centralia
Centralia Oncology Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4762
Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Decatur Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-876-4762
Dixon
Illinois CancerCare-Dixon
Status: ACTIVE
Contact: Site Public Contact
Phone: 815-285-7800
Effingham
Carle Physician Group-Effingham
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Eureka
Illinois CancerCare-Eureka
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Galesburg
Illinois CancerCare-Galesburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Western Illinois Cancer Treatment Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-344-2831
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Macomb
Illinois CancerCare-Macomb
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
O'Fallon
Cancer Care Center of O'Fallon
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Pekin
Illinois CancerCare-Pekin
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peoria
Illinois CancerCare-Peoria
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Methodist Medical Center of Illinois
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 309-243-3605
Peru
Illinois CancerCare-Peru
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Valley Radiation Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 815-664-4141
Princeton
Illinois CancerCare-Princeton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Springfield
Memorial Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 217-788-3528
Southern Illinois University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-444-7541
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
The Carle Foundation Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Washington
Illinois CancerCare - Washington
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Yorkville
Rush-Copley Healthcare Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 630-978-6212

Iowa

Ames
Mary Greeley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
McFarland Clinic PC - Ames
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-239-4734
Boone
McFarland Clinic PC-Boone
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
Carroll
Saint Anthony Regional Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-689-7658
Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-643-2196
Mercy Cancer Center-West Lakes
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-643-2196
Council Bluffs
Alegent Health Mercy Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 402-717-1510
Creston
Greater Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-643-2196
Des Moines
Broadlawns Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2200
Iowa Lutheran Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-241-8704
Iowa Methodist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2921
Medical Oncology and Hematology Associates-Laurel
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-643-2196
Mercy Medical Center - Des Moines
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-643-2196
Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
Trinity Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-574-8302
Jefferson
McFarland Clinic PC-Jefferson
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
Marshalltown
McFarland Clinic PC-Marshalltown
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
West Des Moines
Mercy Medical Center-West Lakes
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-643-2196
Methodist West Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 515-343-1000

Kentucky

Bardstown
Flaget Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 859-629-7169
Corbin
Commonwealth Cancer Center-Corbin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 859-629-7169
Lexington
Saint Joseph Hospital East
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 859-629-7169
Saint Joseph Radiation Oncology Resource Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 859-629-7169
London
Saint Joseph London
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 859-629-7169
Louisville
Jewish Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 859-629-7169
Jewish Hospital Medical Center Northeast
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 859-629-7169
Saints Mary and Elizabeth Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 859-629-7169
Shepherdsville
Jewish Hospital Medical Center South
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 859-629-7169

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-333-5000
Burnsville
Fairview Ridges Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Minnesota Oncology - Burnsville
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Cambridge
Cambridge Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Coon Rapids
Mercy Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Edina
Fairview Southdale Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Fridley
Unity Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Saint John's Hospital - Healtheast
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Minneapolis
Abbott-Northwestern Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Health Partners Inc
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Hennepin County Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Monticello
Monticello Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
New Ulm
New Ulm Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Princeton
Fairview Northland Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Robbinsdale
North Memorial Medical Health Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Saint Paul
Regions Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
United Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Shakopee
Saint Francis Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Stillwater
Lakeview Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Waconia
Ridgeview Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Willmar
Rice Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Wyoming
Fairview Lakes Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Southeast Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-651-5550
Farmington
Parkland Health Center - Farmington
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Jefferson City
Capital Region Southwest Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-632-4814
Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7066
Missouri Baptist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Sullivan
Missouri Baptist Sullivan Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569

Nebraska

Grand Island
CHI Health Saint Francis
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 855-313-2409
Kearney
CHI Health Good Samaritan
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-865-7963
Lincoln
Saint Elizabeth Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 855-313-2409
Omaha
Alegent Health Bergan Mercy Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 402-717-1510
Alegent Health Immanuel Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 402-717-1510
Alegent Health Lakeside Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 402-717-1510
Creighton University Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 402-717-1510
Papillion
Midlands Community Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 402-717-1510

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Fargo
Sanford Broadway Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Sanford Roger Maris Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-234-6161

Ohio

Belpre
Strecker Cancer Center-Belpre
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-523-3977
Chillicothe
Adena Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-779-7585
Cincinnati
Bethesda North Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 513-853-1300
Good Samaritan Hospital - Cincinnati
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 513-853-1300
TriHealth Cancer Institute-Anderson
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 513-853-1300
TriHealth Cancer Institute-Westside
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 513-853-1300
Columbus
Columbus Oncology and Hematology Associates Inc
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Doctors Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-3275
Grant Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-4475
Mount Carmel East Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Mount Carmel Health Center West
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-234-5433
Riverside Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-4475
The Mark H Zangmeister Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Delaware
Delaware Health Center-Grady Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-615-0227
Grady Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-615-2403
Dublin
Dublin Methodist Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-752-9119
Gahanna
Central Ohio Breast and Endocrine Surgery
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2745
Grove City
Mount Carmel Grove City Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-779-7585
Lancaster
Fairfield Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-687-8863
Lima
Saint Rita's Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 419-226-9617
Mansfield
OhioHealth Mansfield Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 419-526-8018
Marietta
Marietta Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-523-3977
Marion
OhioHealth Marion General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Mount Vernon
Knox Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-393-9000
Newark
Licking Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-348-4000
Newark Radiation Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Perrysburg
Mercy Health Perrysburg Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Portsmouth
Southern Ohio Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Toledo
Mercy Health - Saint Anne Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Saint Vincent Mercy Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Westerville
Saint Ann's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-234-5433
Zanesville
Genesis Healthcare System Cancer Care Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-454-5232

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777
Tulsa
Oklahoma Cancer Specialists and Research Institute-Tulsa
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 918-505-3200

South Carolina

Georgetown
Tidelands Georgetown Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 843-545-5600

South Dakota

Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320

Texas

Bryan
Saint Joseph Regional Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 855-313-2409

Washington

Bremerton
Harrison Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-426-6882
Burien
Highline Medical Center-Main Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-426-6882
Enumclaw
Saint Elizabeth Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-426-6882
Federal Way
Saint Francis Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-426-6882
Lakewood
Saint Clare Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-426-6882
Tacoma
Franciscan Research Center-Northwest Medical Plaza
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-426-6882

Wisconsin

La Crosse
Mayo Clinic Health System-Franciscan Healthcare
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 855-776-0015
Mukwonago
ProHealth D N Greenwald Center
Status: ACTIVE
Contact: Site Public Contact
New Richmond
Cancer Center of Western Wisconsin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 952-993-1517
Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-7878
Waukesha
ProHealth Waukesha Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-7632
UW Cancer Center at ProHealth Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-5539

PRIMARY OBJECTIVE:

I. To determine whether escalating maintenance therapy with the addition of ixazomib citrate (ixazomib) to lenalidomide improves overall survival among patients who are MRD positive after approximately 1 year of lenalidomide maintenance following an early stem cell transplant (=< 12 months from diagnosis).

SECONDARY OBJECTIVES:

I. To establish whether progression-free survival is superior with the addition of ixazomib to lenalidomide maintenance.

II. To evaluate best response on treatment and compare response rates between arms.

III. To evaluate the safety profile of ixazomib added to lenalidomide and compare toxicity rates between arms.

EXPLORATORY CLINICAL OBJECTIVES:

I. To measure treatment exposure and adherence.

II. To estimate treatment duration, duration of response and time to progression.

PATIENT-REPORTED OUTCOMES OBJECTIVES:

I. To determine the extent and timing of neuropathy associated with the addition of ixazomib to lenalidomide maintenance on patient reported health-related quality of life outcomes.

II. To assess the impact and timing of disease control with the addition of ixazomib to lenalidomide maintenance on patient reported health-related quality of life outcomes.

III. To evaluate attributes of select patient reported treatment-emergent symptomatic adverse events (Patient-Reported Outcomes - Common Terminology Criteria for Adverse Events [PRO-CTCAE]) longitudinally and compare responses with provider-reported adverse events.

IV. To measure the likelihood of medication adherence and examine the relationship with treatment exposure.

V. To assess correlation among patient reported outcome measures and association with clinical outcomes.

VI. To tabulate PRO compliance and completion rates.

IMAGING OBJECTIVES:

I. To evaluate the association between baseline fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) and patient outcomes.

II. To compare overall survival (OS) with the addition of ixazomib to lenalidomide among baseline 18F-FDG PET/CT-positive and 18F-FDG PET/CT -negative subgroups.

III. To compare the change in quantitative 18F-FDG PET/CT parameters over time with the addition of ixazomib to lenalidomide.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-28 and ixazomib citrate PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive lenalidomide PO QD on days 1-28 and a placebo PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months if < 2 years from study entry, every 6 months if 2-5 years from study entry, then every 12 months for up to 10 years from study entry.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
ECOG-ACRIN Cancer Research Group

Principal Investigator
Shaji K. Kumar

  • Primary ID EAA171
  • Secondary IDs NCI-2019-02790
  • Clinicaltrials.gov ID NCT03941860