Blood Cancer
EAA171 / OPTIMUM
Testing the Addition of Ixazomib/Placebo to Lenalidomide in Patients with Evidence of Residual Multiple Myeloma, OPTIMUM Trial
STATUS: Closed to Accrual and Intervention
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.
- STEP 0: PRE-REGISTRATION
- Patient must be >= 18 years of age
- Patient must be previously diagnosed with multiple myeloma (MM) and be on lenalidomide maintenance with >= 5mg daily for at least 6 months and no more than 18 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
- Patient must be able to undergo a diagnostic bone marrow aspirate following pre-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 to the submitting institution within three (3) business days of receipt of the bone marrow specimen
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Patient must not have primary refractory or progressive disease on a proteasome inhibitor-based regimen during induction therapy prior to stem cell transplant
- Patient 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
- Patient must not have uncontrolled psychiatric illness or social situations that would limit compliance with study requirements
- Patient must not have another malignancy requiring treatment or have received treatment within two 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
- Patient must have been able to maintain at least 5mg daily dose of lenalidomide without growth factor support
- 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
- Patient 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
- Patient must have 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 (ANC) >= 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 (ULN) (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 (ULN) (obtained =< 14 days prior to randomization)
- Patients must not have grade 2 or higher peripheral neuropathy or grade 1 peripheral neuropathy with pain per Common Terminology Criteria for Adverse Events (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 (such as 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) registered trademark program and be willing and able to comply with the requirements of Revlimid REMS registered trademark
- 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
United States
AR
Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
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AZ
Phoenix
Cancer Center at Saint Joseph's
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CA
Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
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Pacific Central Coast Health Center-San Luis Obispo
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Santa Maria
Mission Hope Medical Oncology - Santa Maria
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CO
Colorado Springs
Penrose-Saint Francis Healthcare
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Rocky Mountain Cancer Centers-Penrose
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Denver
Porter Adventist Hospital
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Durango
Mercy Medical Center
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Southwest Oncology PC
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Lakewood
Saint Anthony Hospital
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Littleton
Littleton Adventist Hospital
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Longmont
Longmont United Hospital
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Rocky Mountain Cancer Centers-Longmont
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Parker Adventist Hospital
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Saint Mary Corwin Medical Center
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IA
Ames
Mary Greeley Medical Center
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McFarland Clinic - Ames
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Boone
McFarland Clinic - Boone
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Carroll
Saint Anthony Regional Hospital
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Clive
Mercy Cancer Center-West Lakes
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Mission Cancer and Blood - West Des Moines
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Council Bluffs
Alegent Health Mercy Hospital
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Creston
Greater Regional Medical Center
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Des Moines
Broadlawns Medical Center
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Iowa Lutheran Hospital
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Iowa Methodist Medical Center
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Mercy Medical Center - Des Moines
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Mission Cancer and Blood - Laurel
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Fort Dodge
McFarland Clinic - Trinity Cancer Center
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Trinity Regional Medical Center
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McFarland Clinic - Jefferson
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Marshalltown
McFarland Clinic - Marshalltown
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Mercy Medical Center-West Lakes
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Methodist West Hospital
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IL
Aurora
Rush - Copley Medical Center
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Bloomington
Illinois CancerCare-Bloomington
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Canton
Illinois CancerCare-Canton
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Carbondale
Memorial Hospital of Carbondale
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Carterville
SIH Cancer Institute
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Carthage
Illinois CancerCare-Carthage
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Centralia
Centralia Oncology Clinic
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Carle at The Riverfront
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Decatur
Cancer Care Specialists of Illinois - Decatur
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Decatur Memorial Hospital
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Dixon
Illinois CancerCare-Dixon
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Effingham
Carle Physician Group-Effingham
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Crossroads Cancer Center
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Eureka
Illinois CancerCare-Eureka
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Galesburg
Illinois CancerCare-Galesburg
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Western Illinois Cancer Treatment Center
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Kewanee
Illinois CancerCare-Kewanee Clinic
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Macomb
Illinois CancerCare-Macomb
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Mattoon
Carle Physician Group-Mattoon/Charleston
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O'Fallon
Cancer Care Center of O'Fallon
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Ottawa
Illinois CancerCare-Ottawa Clinic
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Pekin
Illinois CancerCare-Pekin
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Peoria
Illinois CancerCare-Peoria
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Methodist Medical Center of Illinois
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Peru
Illinois CancerCare-Peru
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Valley Radiation Oncology
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Princeton
Illinois CancerCare-Princeton
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Springfield
Memorial Medical Center
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Southern Illinois University School of Medicine
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Springfield Clinic
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Urbana
Carle Cancer Center
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The Carle Foundation Hospital
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Washington
Illinois CancerCare - Washington
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Yorkville
Rush-Copley Healthcare Center
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KS
Wichita
Ascension Via Christi Hospitals Wichita
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Email: Keisha.humphries@ascension.org
Cancer Center of Kansas - Wichita
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Cancer Center of Kansas-Wichita Medical Arts Tower
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KY
Bardstown
Flaget Memorial Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org
Corbin
Commonwealth Cancer Center-Corbin
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Lexington
Saint Joseph Hospital East
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Saint Joseph Radiation Oncology Resource Center
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London
Saint Joseph London
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Louisville
Jewish Hospital
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Saints Mary and Elizabeth Hospital
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UofL Health Medical Center Northeast
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Shepherdsville
Jewish Hospital Medical Center South
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MA
Boston
Tufts Medical Center
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MI
Ann Arbor
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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University of Michigan Comprehensive Cancer Center
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Battle Creek
Bronson Battle Creek
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Brighton
Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Trinity Health Medical Center - Brighton
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Canton
Trinity Health IHA Medical Group Hematology Oncology - Canton
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Trinity Health Medical Center - Canton
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Chelsea
Chelsea Hospital
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Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Detroit
Henry Ford Health Saint John Hospital
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East China
Great Lakes Cancer Management Specialists-Doctors Park
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Flint
Genesee Cancer and Blood Disease Treatment Center
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Email: wstrong@ghci.org
Genesee Hematology Oncology PC
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Genesys Hurley Cancer Institute
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Grand Rapids
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Trinity Health Grand Rapids Hospital
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Grosse Pointe Woods
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
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Henry Ford Saint John Hospital - Academic
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Kalamazoo
Ascension Borgess Cancer Center
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Bronson Methodist Hospital
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West Michigan Cancer Center
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Livonia
Trinity Health Saint Mary Mercy Livonia Hospital
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Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
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Muskegon
Trinity Health Muskegon Hospital
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Email: crcwm-regulatory@crcwm.org
Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
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Reed City
Corewell Health Reed City Hospital
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Saint Joseph
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
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Traverse City
Munson Medical Center
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Warren
Great Lakes Cancer Management Specialists-Macomb Professional Building
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Macomb Hematology Oncology PC
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Saint John Macomb-Oakland Hospital
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Wyoming
University of Michigan Health - West
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Email: crcwm-regulatory@crcwm.org
Ypsilanti
Huron Gastroenterology PC
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Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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Email: MCRCwebsitecontactform@stjoeshealth.org
MN
Bemidji
Sanford Joe Lueken Cancer Center
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Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Burnsville
Fairview Ridges Hospital
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Email: mmcorc@healthpartners.com
Minnesota Oncology - Burnsville
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Email: mmcorc@healthpartners.com
Cambridge
Cambridge Medical Center
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Coon Rapids
Mercy Hospital
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Edina
Fairview Southdale Hospital
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Fridley
Unity Hospital
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Maple Grove
Fairview Clinics and Surgery Center Maple Grove
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Maplewood
Minnesota Oncology Hematology PA-Maplewood
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Saint John's Hospital - Healtheast
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Minneapolis
Abbott-Northwestern Hospital
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Health Partners Inc
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Hennepin County Medical Center
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Monticello
Monticello Cancer Center
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New Ulm
New Ulm Medical Center
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Princeton
Fairview Northland Medical Center
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Robbinsdale
North Memorial Medical Health Center
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Rochester
Mayo Clinic in Rochester
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Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
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Saint Paul
Regions Hospital
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United Hospital
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Shakopee
Saint Francis Regional Medical Center
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Stillwater
Lakeview Hospital
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Waconia
Ridgeview Medical Center
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Willmar
Rice Memorial Hospital
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Woodbury
Minnesota Oncology Hematology PA-Woodbury
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Wyoming
Fairview Lakes Medical Center
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MO
Cape Girardeau
Saint Francis Medical Center
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Southeast Cancer Center
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Farmington
Parkland Health Center - Farmington
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Jefferson City
MU Health Care Goldschmidt Cancer Center
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Email: swooden@mail.crmc.org
Saint Louis
Mercy Hospital Saint Louis
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Missouri Baptist Medical Center
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Sainte Genevieve
Sainte Genevieve County Memorial Hospital
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Sullivan
Missouri Baptist Sullivan Hospital
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Sunset Hills
BJC Outpatient Center at Sunset Hills
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ND
Bismarck
Sanford Bismarck Medical Center
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Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Fargo
Sanford Broadway Medical Center
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Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Sanford Roger Maris Cancer Center
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Email: OncologyClinicalTrialsFargo@sanfordhealth.org
NE
Grand Island
Nebraska Cancer Specialists/Oncology Hematology West PC
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Kearney
CHI Health Good Samaritan
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Email: ResearchInstituteInquiries@CommonSpirit.org
Lincoln
Saint Elizabeth Regional Medical Center
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Omaha
Alegent Health Bergan Mercy Medical Center
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Alegent Health Immanuel Medical Center
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Alegent Health Lakeside Hospital
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Creighton University Medical Center
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Papillion
Midlands Community Hospital
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OH
Belpre
Strecker Cancer Center-Belpre
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Email: sheree@columbusccop.org
Centerville
Miami Valley Hospital South
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Email: clinical.trials@daytonncorp.org
Chillicothe
Adena Regional Medical Center
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Email: sheree@columbusccop.org
Cincinnati
Bethesda North Hospital
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Good Samaritan Hospital - Cincinnati
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TriHealth Cancer Institute-Anderson
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TriHealth Cancer Institute-Westside
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Columbus
Columbus Oncology and Hematology Associates Inc
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Email: sheree@columbusccop.org
Doctors Hospital
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Email: sheree@columbusccop.org
Grant Medical Center
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Mount Carmel East Hospital
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Mount Carmel Health Center West
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Riverside Methodist Hospital
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The Mark H Zangmeister Center
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Dayton
Miami Valley Hospital
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Miami Valley Hospital North
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Delaware
Delaware Health Center-Grady Cancer Center
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Email: sheree@columbusccop.org
Grady Memorial Hospital
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Dublin
Dublin Methodist Hospital
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Email: sheree@columbusccop.org
Franklin
Atrium Medical Center-Middletown Regional Hospital
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Email: clinical.trials@daytonncorp.org
Gahanna
Central Ohio Breast and Endocrine Surgery
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Email: sheree@columbusccop.org
Grove City
Mount Carmel Grove City Hospital
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Lancaster
Fairfield Medical Center
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Lima
Saint Rita's Medical Center
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Mansfield
OhioHealth Mansfield Hospital
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Marietta
Marietta Memorial Hospital
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Marion
OhioHealth Marion General Hospital
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Mount Vernon
Knox Community Hospital
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Newark
Licking Memorial Hospital
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Newark Radiation Oncology
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Perrysburg
Mercy Health Perrysburg Cancer Center
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Portsmouth
Southern Ohio Medical Center
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Toledo
Mercy Health - Saint Anne Hospital
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Mercy Health - Saint Vincent Hospital
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Troy
Upper Valley Medical Center
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Westerville
Saint Ann's Hospital
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Zanesville
Genesis Healthcare System Cancer Care Center
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Email: sheree@columbusccop.org
OK
Oklahoma City
University of Oklahoma Health Sciences Center
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Email: ou-clinical-trials@ouhsc.edu
Tulsa
Oklahoma Cancer Specialists and Research Institute-Tulsa
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PA
Hershey
Penn State Milton S Hershey Medical Center
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Email: CTO@hmc.psu.edu
PR
San Juan
Centro Comprensivo de Cancer de UPR
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu
SC
Georgetown
Tidelands Georgetown Memorial Hospital
Contact: Site Public Contact
Email: broe@tidelandshealth.org
SD
Sioux Falls
Sanford Cancer Center Oncology Clinic
Contact: Site Public Contact
Email: OncologyClinicTrialsSF@sanfordhealth.org
Sanford USD Medical Center - Sioux Falls
Contact: Site Public Contact
Email: OncologyClinicalTrialsSF@SanfordHealth.org
TX
Bryan
Saint Joseph Regional Cancer Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
WA
Burien
Highline Medical Center-Main Campus
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Enumclaw
Saint Elizabeth Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Federal Way
Saint Francis Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Lakewood
Saint Clare Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Silverdale
Saint Michael Cancer Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Tacoma
Franciscan Research Center-Northwest Medical Plaza
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
WI
Appleton
ThedaCare Regional Cancer Center
Contact: Site Public Contact
Email: ResearchDept@thedacare.org
La Crosse
Mayo Clinic Health System-Franciscan Healthcare
Contact: Site Public Contact
Mukwonago
ProHealth D N Greenwald Center
Contact: Site Public Contact
Email: research.institute@phci.org
New Richmond
Cancer Center of Western Wisconsin
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Contact: Site Public Contact
Waukesha
ProHealth Waukesha Memorial Hospital
Contact: Site Public Contact
UW Cancer Center at ProHealth Care
Contact: Site Public Contact
Email: Chanda.miller@phci.org
PRIMARY OBJECTIVE: I. To evaluate whether escalating maintenance therapy with the addition of ixazomib citrate (ixazomib) to lenalidomide improves overall survival (OS) among patients who are minimal residual disease (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 (PFS) 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 OBJECTIVES: I. To measure treatment exposure and adherence. II. To estimate treatment duration, duration of response and time to progression. PATIENT-REPORTED OUTCOMES (PRO) OBJECTIVES: I. To quantify the extent to which the addition of ixazomib to lenalidomide maintenance contributes to neuropathy and associated physical and functional impairments. (Primary) II. To assess the impact of the addition of ixazomib to lenalidomide maintenance on disease control and associated physical and functional well-being. (Primary) III. To evaluate time to worsening and recovery rate related to neuropathy. (Secondary) IV. To evaluate time to improvement and response rate related to disease control. (Secondary) V. 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. (Exploratory) VI. To measure the likelihood of medication adherence and examine the relationship with treatment exposure. (Exploratory) VII. To assess correlation among patient reported outcome measures and association with clinical outcomes. (Exploratory) VIII. To tabulate PRO compliance and completion rates. (Exploratory) IMAGING OBJECTIVES: I. To evaluate the association between baseline fludeoxyglucose F-18 (18F-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. Patients also undergo bone marrow aspirate and/or biopsy and positron emission tomography (PET) and computed tomography (CT) scan at screening and on study as well as undergo collection of blood samples throughout the trial. 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. Patients also undergo bone marrow aspirate and/or biopsy and PET and CT scan at screening and on study as well as undergo collection of blood samples throughout the trial. 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.
Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.
The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.