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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Email: ResearchInstituteInquiries@CommonSpirit.org

AZ
Phoenix
Cancer Center at Saint Joseph's
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Email: CancerInstitute@DignityHealth.org

CA
Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
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Email: ResearchInstituteInquiries@CommonSpirit.org

San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
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Email: ResearchInstituteInquiries@CommonSpirit.org

Santa Maria
Mission Hope Medical Oncology - Santa Maria
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Email: ResearchInstituteInquiries@CommonSpirit.org

CO
Colorado Springs
Penrose-Saint Francis Healthcare
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Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Penrose
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Email: ResearchTracking@Centura.Org

Denver
Porter Adventist Hospital
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Email: ResearchTracking@Centura.Org

Durango
Mercy Medical Center
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Email: ResearchTracking@Centura.Org

Southwest Oncology PC
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Email: ResearchTracking@Centura.Org

Lakewood
Saint Anthony Hospital
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Email: ResearchTracking@Centura.Org

Littleton
Littleton Adventist Hospital
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Email: ResearchTracking@Centura.Org

Longmont
Longmont United Hospital
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Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Longmont
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Email: ResearchTracking@Centura.Org

Parker
Parker Adventist Hospital
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Email: ResearchTracking@Centura.Org

Pueblo
Saint Mary Corwin Medical Center
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Email: ResearchTracking@Centura.Org

IA
Ames
Mary Greeley Medical Center
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McFarland Clinic - Ames
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Email: ksoder@mcfarlandclinic.com

Boone
McFarland Clinic - Boone
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Carroll
Saint Anthony Regional Hospital
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Email: sbenson@iora.org

Clive
Medical Oncology and Hematology Associates-West Des Moines
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Mercy Cancer Center-West Lakes
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Email: cancerresearch@mercydesmoines.org

Council Bluffs
Alegent Health Mercy Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org

Creston
Greater Regional Medical Center
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Email: cancerresearch@mercydesmoines.org

Des Moines
Broadlawns Medical Center
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Iowa Lutheran Hospital
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Iowa Methodist Medical Center
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Medical Oncology and Hematology Associates-Des Moines
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Mercy Medical Center - Des Moines
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Email: cancerresearch@mercydesmoines.org

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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Jefferson
McFarland Clinic - Jefferson
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Marshalltown
McFarland Clinic - Marshalltown
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West Des Moines
Mercy Medical Center-West Lakes
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Email: cancerresearch@mercydesmoines.org

Methodist West Hospital
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IL
Aurora
Rush - Copley Medical Center
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Email: Cancer.Research@rushcopley.com

Bloomington
Illinois CancerCare-Bloomington
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Email: andersonj@illinoiscancercare.com

Canton
Illinois CancerCare-Canton
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Email: andersonj@illinoiscancercare.com

Carbondale
Memorial Hospital of Carbondale
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Email: clinical.research@sih.net

Carterville
SIH Cancer Institute
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Email: clinical.research@sih.net

Carthage
Illinois CancerCare-Carthage
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Email: andersonj@illinoiscancercare.com

Centralia
Centralia Oncology Clinic
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Email: morganthaler.jodi@mhsil.com

Danville
Carle at The Riverfront
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Email: Research@carle.com

Decatur
Cancer Care Specialists of Illinois - Decatur
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Email: morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
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Email: morganthaler.jodi@mhsil.com

Dixon
Illinois CancerCare-Dixon
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Effingham
Carle Physician Group-Effingham
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Email: Research@carle.com

Crossroads Cancer Center
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Email: morganthaler.jodi@mhsil.com

Eureka
Illinois CancerCare-Eureka
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Email: andersonj@illinoiscancercare.com

Galesburg
Illinois CancerCare-Galesburg
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Email: andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
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Kewanee
Illinois CancerCare-Kewanee Clinic
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Email: andersonj@illinoiscancercare.com

Macomb
Illinois CancerCare-Macomb
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Email: andersonj@illinoiscancercare.com

Mattoon
Carle Physician Group-Mattoon/Charleston
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Email: Research@carle.com

O'Fallon
Cancer Care Center of O'Fallon
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Email: morganthaler.jodi@mhsil.com

Ottawa
Illinois CancerCare-Ottawa Clinic
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Email: andersonj@illinoiscancercare.com

Pekin
Illinois CancerCare-Pekin
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Email: andersonj@illinoiscancercare.com

Peoria
Illinois CancerCare-Peoria
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Email: andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
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Email: andersonj@illinoiscancercare.com

Peru
Illinois CancerCare-Peru
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Email: andersonj@illinoiscancercare.com

Valley Radiation Oncology
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Princeton
Illinois CancerCare-Princeton
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Email: andersonj@illinoiscancercare.com

Springfield
Memorial Medical Center
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Email: pallante.beth@mhsil.com

Southern Illinois University School of Medicine
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Springfield Clinic
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Urbana
Carle Cancer Center
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Email: Research@carle.com

The Carle Foundation Hospital
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Email: Research@carle.com

Washington
Illinois CancerCare - Washington
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Email: andersonj@illinoiscancercare.com

Yorkville
Rush-Copley Healthcare Center
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Email: Cancer.Research@rushcopley.com

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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Email: Keisha.humphries@ascension.org

Cancer Center of Kansas-Wichita Medical Arts Tower
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Email: Keisha.humphries@ascension.org

KY
Bardstown
Flaget Memorial Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org

Corbin
Commonwealth Cancer Center-Corbin
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Email: ResearchInstituteInquiries@CommonSpirit.org

Lexington
Saint Joseph Hospital East
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Email: ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Radiation Oncology Resource Center
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Email: ResearchInstituteInquiries@CommonSpirit.org

London
Saint Joseph London
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Email: ResearchInstituteInquiries@CommonSpirit.org

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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Email: ctoinfo@louisville.edu

Shepherdsville
Jewish Hospital Medical Center South
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MA
Boston
Tufts Medical Center
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Email: ContactUsCancerCenter@TuftsMedicalCenter.org

MI
Ann Arbor
Saint Joseph Mercy Hospital
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Email: MCRCwebsitecontactform@stjoeshealth.org

University of Michigan Comprehensive Cancer Center
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Battle Creek
Bronson Battle Creek
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Email: crcwm-regulatory@crcwm.org

Brighton
Saint Joseph Mercy Brighton
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Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Email: MCRCwebsitecontactform@stjoeshealth.org

Canton
Saint Joseph Mercy Canton
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Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Canton
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Email: MCRCwebsitecontactform@stjoeshealth.org

Chelsea
Saint Joseph Mercy Chelsea
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Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Email: MCRCwebsitecontactform@stjoeshealth.org

Detroit
Ascension Saint John Hospital
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Email: karen.forman@ascension.org

East China
Great Lakes Cancer Management Specialists-Doctors Park
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Email: karen.forman@ascension.org

Flint
Genesee Cancer and Blood Disease Treatment Center
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Email: wstrong@ghci.org

Genesee Hematology Oncology PC
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Email: wstrong@ghci.org

Genesys Hurley Cancer Institute
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Email: wstrong@ghci.org

Grand Rapids
Spectrum Health at Butterworth Campus
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Email: crcwm-regulatory@crcwm.org

Trinity Health Grand Rapids Hospital
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Email: crcwm-regulatory@crcwm.org

Grosse Pointe Woods
Academic Hematology Oncology Specialists
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Email: karen.forman@ascension.org

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
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Email: karen.forman@ascension.org

Kalamazoo
Ascension Borgess Cancer Center
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Email: crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
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Email: crcwm-regulatory@crcwm.org

West Michigan Cancer Center
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Email: crcwm-regulatory@crcwm.org

Livonia
Trinity Health Saint Mary Mercy Livonia Hospital
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Email: MCRCwebsitecontactform@stjoeshealth.org

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

Muskegon
Trinity Health Muskegon Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

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

Reed City
Corewell Health Reed City Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Saint Joseph
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

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

Traverse City
Munson Medical Center
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Email: crcwm-regulatory@crcwm.org

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

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

Saint John Macomb-Oakland Hospital
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Email: karen.forman@ascension.org

Wyoming
University of Michigan Health - West
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

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

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

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

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

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

Cambridge
Cambridge Medical Center
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Email: mmcorc@healthpartners.com

Coon Rapids
Mercy Hospital
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Email: mmcorc@healthpartners.com

Edina
Fairview Southdale Hospital
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Email: mmcorc@healthpartners.com

Fridley
Unity Hospital
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Email: mmcorc@healthpartners.com

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

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

Saint John's Hospital - Healtheast
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Email: mmcorc@healthpartners.com

Minneapolis
Abbott-Northwestern Hospital
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Email: mmcorc@healthpartners.com

Health Partners Inc
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Email: mmcorc@healthpartners.com

Hennepin County Medical Center
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Email: mmcorc@healthpartners.com

Monticello
Monticello Cancer Center
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Email: mmcorc@healthpartners.com

New Ulm
New Ulm Medical Center
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Email: mmcorc@healthpartners.com

Princeton
Fairview Northland Medical Center
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Email: mmcorc@healthpartners.com

Robbinsdale
North Memorial Medical Health Center
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Email: mmcorc@healthpartners.com

Rochester
Mayo Clinic in Rochester
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Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
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Email: mmcorc@healthpartners.com

Saint Paul
Regions Hospital
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Email: mmcorc@healthpartners.com

United Hospital
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Email: mmcorc@healthpartners.com

Shakopee
Saint Francis Regional Medical Center
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Email: mmcorc@healthpartners.com

Stillwater
Lakeview Hospital
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Email: mmcorc@healthpartners.com

Waconia
Ridgeview Medical Center
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Email: mmcorc@healthpartners.com

Willmar
Rice Memorial Hospital
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Email: mmcorc@healthpartners.com

Woodbury
Minnesota Oncology Hematology PA-Woodbury
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Email: mmcorc@healthpartners.com

Wyoming
Fairview Lakes Medical Center
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Email: mmcorc@healthpartners.com

MO
Cape Girardeau
Saint Francis Medical Center
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Email: sfmc@sfmc.net

Southeast Cancer Center
Contact: Site Public Contact

Farmington
Parkland Health Center - Farmington
Contact: Site Public Contact

Jefferson City
Capital Region Southwest Campus
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Email: swooden@mail.crmc.org

Saint Louis
Mercy Hospital Saint Louis
Contact: Site Public Contact

Missouri Baptist Medical Center
Contact: Site Public Contact

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

Sullivan
Missouri Baptist Sullivan Hospital
Contact: Site Public Contact

Sunset Hills
BJC Outpatient Center at Sunset Hills
Contact: Site Public Contact

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

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

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

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

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

Lincoln
Saint Elizabeth Regional Medical Center
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Email: ResearchInstituteInquiries@CommonSpirit.org

Omaha
Alegent Health Bergan Mercy Medical Center
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Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Immanuel Medical Center
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Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Lakeside Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org

Creighton University Medical Center
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Email: ResearchInstituteInquiries@CommonSpirit.org

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

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

Centerville
Miami Valley Hospital South
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

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

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

Good Samaritan Hospital - Cincinnati
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Email: ResearchInstituteInquiries@CommonSpirit.org

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

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

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

Doctors Hospital
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Email: sheree@columbusccop.org

Grant Medical Center
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Email: sheree@columbusccop.org

Mount Carmel East Hospital
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Email: sheree@columbusccop.org

Mount Carmel Health Center West
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Email: sheree@columbusccop.org

Riverside Methodist Hospital
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Email: sheree@columbusccop.org

The Mark H Zangmeister Center
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Email: sheree@columbusccop.org

Dayton
Miami Valley Hospital
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Email: clinical.trials@daytonncorp.org

Miami Valley Hospital North
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

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

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

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

Franklin
Atrium Medical Center-Middletown Regional Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

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

Grove City
Mount Carmel Grove City Hospital
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Email: sheree@columbusccop.org

Lancaster
Fairfield Medical Center
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Email: sheree@columbusccop.org

Lima
Saint Rita's Medical Center
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Mansfield
OhioHealth Mansfield Hospital
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Email: sheree@columbusccop.org

Marietta
Marietta Memorial Hospital
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Email: sheree@columbusccop.org

Marion
OhioHealth Marion General Hospital
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Email: sheree@columbusccop.org

Mount Vernon
Knox Community Hospital
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Email: sheree@columbusccop.org

Newark
Licking Memorial Hospital
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Email: sheree@columbusccop.org

Newark Radiation Oncology
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Email: sheree@columbusccop.org

Perrysburg
Mercy Health Perrysburg Cancer Center
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Email: sheree@columbusccop.org

Portsmouth
Southern Ohio Medical Center
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Email: sheree@columbusccop.org

Toledo
Mercy Health - Saint Anne Hospital
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Email: sheree@columbusccop.org

Saint Vincent Mercy Medical Center
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Email: sheree@columbusccop.org

Troy
Upper Valley Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

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

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

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

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

PA
Hershey
Penn State Milton S Hershey Medical Center
Contact: Site Public Contact
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

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.


EAA171 / OPTIMUM (Closed)
ECOG-ACRIN Cancer Research Group