Blood Cancer

EAA171 / OPTIMUM



Testing the Addition of Ixazomib to Lenalidomide in Patients with Evidence of Residual Multiple Myeloma, OPTIMUM 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.
  • 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 patientโ€™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

United States
AR
Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

AZ
Phoenix
Cancer Center at Saint Joseph's
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: CancerInstitute@DignityHealth.org

CA
Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Santa Maria
Mission Hope Medical Oncology - Santa Maria
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

CO
Colorado Springs
Penrose-Saint Francis Healthcare
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Penrose
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Denver
Porter Adventist Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Durango
Mercy Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Southwest Oncology PC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Lakewood
Saint Anthony Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Littleton
Littleton Adventist Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Longmont
Longmont United Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Longmont
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Parker
Parker Adventist Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

Pueblo
Saint Mary Corwin Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchTracking@Centura.Org

IA
Ames
Mary Greeley Medical Center
Status: ACTIVE
Contact: Site Public Contact

McFarland Clinic PC - Ames
Status: ACTIVE
Contact: Site Public Contact
Email: ksoder@mcfarlandclinic.com

Boone
McFarland Clinic PC-Boone
Status: ACTIVE
Contact: Site Public Contact

Carroll
Saint Anthony Regional Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: sbenson@iora.org

Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Mercy Cancer Center-West Lakes
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Council Bluffs
Alegent Health Mercy Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Creston
Greater Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Des Moines
Broadlawns Medical Center
Status: ACTIVE
Contact: Site Public Contact

Iowa Lutheran Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Iowa Methodist Medical Center
Status: ACTIVE
Contact: Site Public Contact

Medical Oncology and Hematology Associates-Des Moines
Status: ACTIVE
Contact: Site Public Contact

Mercy Medical Center - Des Moines
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Mission Cancer and Blood - Laurel
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Trinity Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Jefferson
McFarland Clinic PC-Jefferson
Status: ACTIVE
Contact: Site Public Contact

Marshalltown
McFarland Clinic PC-Marshalltown
Status: ACTIVE
Contact: Site Public Contact

West Des Moines
Mercy Medical Center-West Lakes
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Methodist West Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

IL
Aurora
Rush - Copley Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

Bloomington
Illinois CancerCare-Bloomington
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Canton
Illinois CancerCare-Canton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Carbondale
Memorial Hospital of Carbondale
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.research@sih.net

Carterville
SIH Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: clinical.research@sih.net

Carthage
Illinois CancerCare-Carthage
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Centralia
Centralia Oncology Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Dixon
Illinois CancerCare-Dixon
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Effingham
Carle Physician Group-Effingham
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Eureka
Illinois CancerCare-Eureka
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Galesburg
Illinois CancerCare-Galesburg
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Kewanee
Illinois CancerCare-Kewanee Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Macomb
Illinois CancerCare-Macomb
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

O'Fallon
Cancer Care Center of O'Fallon
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Ottawa
Illinois CancerCare-Ottawa Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Pekin
Illinois CancerCare-Pekin
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peoria
Illinois CancerCare-Peoria
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peru
Illinois CancerCare-Peru
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Valley Radiation Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Princeton
Illinois CancerCare-Princeton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Springfield
Memorial Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: pallante.beth@mhsil.com

Southern Illinois University School of Medicine
Status: ACTIVE
Contact: Site Public Contact

Springfield Clinic
Status: ACTIVE
Contact: Site Public Contact

Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

The Carle Foundation Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Research@carle.com

Washington
Illinois CancerCare - Washington
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Yorkville
Rush-Copley Healthcare Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

KS
Wichita
Ascension Via Christi Hospitals Wichita
Status: ACTIVE
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Cancer Center of Kansas - Wichita
Status: ACTIVE
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Cancer Center of Kansas-Wichita Medical Arts Tower
Status: ACTIVE
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

KY
Bardstown
Flaget Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Corbin
Commonwealth Cancer Center-Corbin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Lexington
Saint Joseph Hospital East
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Radiation Oncology Resource Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

London
Saint Joseph London
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Louisville
Jewish Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Saints Mary and Elizabeth Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

UofL Health Medical Center Northeast
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctoinfo@louisville.edu

Shepherdsville
Jewish Hospital Medical Center South
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

MA
Boston
Tufts Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: ContactUsCancerCenter@TuftsMedicalCenter.org

MI
Ann Arbor
Saint Joseph Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Battle Creek
Bronson Battle Creek
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Brighton
Saint Joseph Mercy Brighton
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Brighton
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Canton
Saint Joseph Mercy Canton
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Canton
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Chelsea
Saint Joseph Mercy Chelsea
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Detroit
Ascension Saint John Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

East China
Great Lakes Cancer Management Specialists-Doctors Park
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

Flint
Genesee Cancer and Blood Disease Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Email: wstrong@ghci.org

Genesee Hematology Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Email: wstrong@ghci.org

Genesys Hurley Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Email: wstrong@ghci.org

Grand Rapids
Mercy Health Saint Mary's
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Spectrum Health at Butterworth Campus
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Grosse Pointe Woods
Academic Hematology Oncology Specialists
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

Kalamazoo
Ascension Borgess Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Livonia
Trinity Health Saint Mary Mercy Livonia Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

Muskegon
Mercy Health Mercy Campus
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Status: ACTIVE
Contact: Site Public Contact
Email: connie.szczepanek@crcwm.org

Reed City
Spectrum Health Reed City Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Saint Joseph
Marie Yeager Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

Traverse City
Munson Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Warren
Great Lakes Cancer Management Specialists-Macomb Professional Building
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

Macomb Hematology Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

Saint John Macomb-Oakland Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: karen.forman@ascension.org

Wyoming
Metro Health Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Ypsilanti
Huron Gastroenterology PC
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Status: ACTIVE
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

MN
Bemidji
Sanford Joe Lueken Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Burnsville
Fairview Ridges Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minnesota Oncology - Burnsville
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Cambridge
Cambridge Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Coon Rapids
Mercy Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Edina
Fairview Southdale Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Fridley
Unity Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint John's Hospital - Healtheast
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minneapolis
Abbott-Northwestern Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Health Partners Inc
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Hennepin County Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Monticello
Monticello Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

New Ulm
New Ulm Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Princeton
Fairview Northland Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Robbinsdale
North Memorial Medical Health Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Site Public Contact

Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint Paul
Regions Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

United Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Shakopee
Saint Francis Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Stillwater
Lakeview Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Waconia
Ridgeview Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Willmar
Rice Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Wyoming
Fairview Lakes Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

MO
Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: sfmc@sfmc.net

Southeast Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Farmington
Parkland Health Center - Farmington
Status: ACTIVE
Contact: Site Public Contact

Jefferson City
Capital Region Southwest Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: swooden@mail.crmc.org

Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact

Missouri Baptist Medical Center
Status: ACTIVE
Contact: Site Public Contact

Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact

Sullivan
Missouri Baptist Sullivan Hospital
Status: ACTIVE
Contact: Site Public Contact

Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: ACTIVE
Contact: Site Public Contact

ND
Bismarck
Sanford Bismarck Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Fargo
Sanford Broadway Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

NE
Grand Island
CHI Health Saint Francis
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Kearney
CHI Health Good Samaritan
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Lincoln
Saint Elizabeth Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Omaha
Alegent Health Bergan Mercy Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Immanuel Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Lakeside Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Creighton University Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Papillion
Midlands Community Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

OH
Belpre
Strecker Cancer Center-Belpre
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

Chillicothe
Adena Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

Cincinnati
Bethesda North Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Good Samaritan Hospital - Cincinnati
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Anderson
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Westside
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Columbus
Columbus Oncology and Hematology Associates Inc
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

Doctors Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

Grant Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

Mount Carmel East Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

Mount Carmel Health Center West
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

Riverside Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

The Mark H Zangmeister Center
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

Delaware
Delaware Health Center-Grady Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

Grady Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

Dublin
Dublin Methodist Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: sheree@columbusccop.org

Gahanna
Central Ohio Breast and Endocrine Surgery
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: sheree@columbusccop.org

Grove City
Mount Carmel Grove City Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: sheree@columbusccop.org

Lancaster
Fairfield Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

Lima
Saint Rita's Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Mansfield
OhioHealth Mansfield Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: sheree@columbusccop.org

Marietta
Marietta Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

Marion
OhioHealth Marion General Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

Mount Vernon
Knox Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

Newark
Licking Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

Newark Radiation Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: sheree@columbusccop.org

Perrysburg
Mercy Health Perrysburg Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: sheree@columbusccop.org

Portsmouth
Southern Ohio Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

Toledo
Mercy Health - Saint Anne Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: sheree@columbusccop.org

Saint Vincent Mercy Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: sheree@columbusccop.org

Westerville
Saint Ann's Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

Zanesville
Genesis Healthcare System Cancer Care Center
Status: ACTIVE
Contact: Site Public Contact
Email: sheree@columbusccop.org

OK
Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu

Tulsa
Oklahoma Cancer Specialists and Research Institute-Tulsa
Status: ACTIVE
Contact: Site Public Contact

PA
Hershey
Penn State Milton S Hershey Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: CTO@hmc.psu.edu

SC
Georgetown
Tidelands Georgetown Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: broe@tidelandshealth.org

SD
Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: OncologyClinicTrialsSF@sanfordhealth.org

Sanford USD Medical Center - Sioux Falls
Status: ACTIVE
Contact: Site Public Contact
Email: OncologyClinicalTrialsSF@SanfordHealth.org

TX
Bryan
Saint Joseph Regional Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

WI
Appleton
ThedaCare Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: ResearchDept@thedacare.org

La Crosse
Mayo Clinic Health System-Franciscan Healthcare
Status: ACTIVE
Contact: Site Public Contact

Mukwonago
ProHealth D N Greenwald Center
Status: ACTIVE
Contact: Site Public Contact
Email: research.institute@phci.org

New Richmond
Cancer Center of Western Wisconsin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact

Waukesha
ProHealth Waukesha Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact

UW Cancer Center at ProHealth Care
Status: ACTIVE
Contact: Site Public Contact
Email: Chanda.miller@phci.org

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.

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.


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