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

PHASE3CompletedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

February 16, 2022

Primary Completion Date

August 6, 2023

Study Completion Date

January 31, 2025

Conditions
Multiple Myeloma
Interventions
PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Bone Marrow Aspirate

Undergo bone marrow aspirate

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Ixazomib Citrate

Given PO

DRUG

Lenalidomide

Given PO

OTHER

Placebo Administration

Given PO

PROCEDURE

Positron Emission Tomography

Undergo PET scan

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Trial Locations (222)

29440

Tidelands Georgetown Memorial Hospital, Georgetown

40004

Flaget Memorial Hospital, Bardstown

40165

Jewish Hospital Medical Center South, Shepherdsville

40202

Jewish Hospital, Louisville

40215

Saints Mary and Elizabeth Hospital, Louisville

40245

UofL Health Medical Center Northeast, Louisville

40504

Saint Joseph Radiation Oncology Resource Center, Lexington

40509

Saint Joseph Hospital East, Lexington

40701

Commonwealth Cancer Center-Corbin, Corbin

40741

Saint Joseph London, London

43015

Delaware Health Center-Grady Cancer Center, Delaware

Grady Memorial Hospital, Delaware

43016

Dublin Methodist Hospital, Dublin

43050

Knox Community Hospital, Mount Vernon

43055

Licking Memorial Hospital, Newark

Newark Radiation Oncology, Newark

43081

Saint Ann's Hospital, Westerville

43123

Mount Carmel Grove City Hospital, Grove City

43130

Fairfield Medical Center, Lancaster

43213

Mount Carmel East Hospital, Columbus

43214

Columbus Oncology and Hematology Associates Inc, Columbus

Riverside Methodist Hospital, Columbus

43215

Grant Medical Center, Columbus

43219

The Mark H Zangmeister Center, Columbus

43222

Mount Carmel Health Center West, Columbus

43228

Doctors Hospital, Columbus

43230

Central Ohio Breast and Endocrine Surgery, Gahanna

43302

OhioHealth Marion General Hospital, Marion

43551

Mercy Health - Perrysburg Hospital, Perrysburg

43608

Mercy Health - Saint Vincent Hospital, Toledo

43623

Mercy Health - Saint Anne Hospital, Toledo

43701

Genesis Healthcare System Cancer Care Center, Zanesville

44903

OhioHealth Mansfield Hospital, Mansfield

45220

Good Samaritan Hospital - Cincinnati, Cincinnati

45242

Bethesda North Hospital, Cincinnati

45247

TriHealth Cancer Institute-Westside, Cincinnati

45255

TriHealth Cancer Institute-Anderson, Cincinnati

45373

Upper Valley Medical Center, Troy

45409

Miami Valley Hospital, Dayton

45415

Miami Valley Hospital North, Dayton

45459

Miami Valley Hospital South, Centerville

45601

Adena Regional Medical Center, Chillicothe

45662

Southern Ohio Medical Center, Portsmouth

45714

Strecker Cancer Center-Belpre, Belpre

45750

Marietta Memorial Hospital, Marietta

45801

Saint Rita's Medical Center, Lima

48044

Henry Ford Saint John Hospital - Macomb Medical, Macomb

48054

Henry Ford River District Hospital, East China Township

48093

Henry Ford Health Warren Hospital, Warren

Henry Ford Warren Hospital - GLCMS, Warren

Macomb Hematology Oncology PC, Warren

48106

Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor

Huron Gastroenterology PC, Ypsilanti

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

48114

Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton

Trinity Health Medical Center - Brighton, Brighton

48118

Chelsea Hospital, Chelsea

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea

48154

Trinity Health Saint Mary Mercy Livonia Hospital, Livonia

48188

Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton

Trinity Health Medical Center - Canton, Canton

48197

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti

48236

Henry Ford Health Saint John Hospital, Detroit

Henry Ford Saint John Hospital - Academic, Grosse Pointe Woods

Henry Ford Saint John Hospital - Van Elslander, Grosse Pointe Woods

48312

Bhadresh Nayak MD PC-Sterling Heights, Sterling Heights

48503

Cancer Hematology Centers - Flint, Flint

Genesee Hematology Oncology PC, Flint

Genesys Hurley Cancer Institute, Flint

49007

Bronson Methodist Hospital, Kalamazoo

West Michigan Cancer Center, Kalamazoo

49009

Ascension Borgess Cancer Center, Kalamazoo

49017

Bronson Battle Creek, Battle Creek

49085

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph

49444

Trinity Health Muskegon Hospital, Muskegon

Cancer and Hematology Centers of Western Michigan - Norton Shores, Norton Shores

49503

Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids

Trinity Health Grand Rapids Hospital, Grand Rapids

49519

University of Michigan Health - West, Wyoming

49677

Corewell Health Reed City Hospital, Reed City

49684

Munson Medical Center, Traverse City

50010

Mary Greeley Medical Center, Ames

McFarland Clinic - Ames, Ames

50036

McFarland Clinic - Boone, Boone

50129

McFarland Clinic - Jefferson, Jefferson

50158

McFarland Clinic - Marshalltown, Marshalltown

50266

Mercy Medical Center-West Lakes, West Des Moines

50309

Iowa Methodist Medical Center, Des Moines

Mission Cancer and Blood - Des Moines, Des Moines

50314

Broadlawns Medical Center, Des Moines

Mercy Medical Center - Des Moines, Des Moines

Mission Cancer and Blood - Laurel, Des Moines

50316

Iowa Lutheran Hospital, Des Moines

50325

Mercy Cancer Center-West Lakes, Clive

Mission Cancer and Blood - West Des Moines, Clive

50501

McFarland Clinic - Trinity Cancer Center, Fort Dodge

Trinity Regional Medical Center, Fort Dodge

50801

Greater Regional Medical Center, Creston

51401

Saint Anthony Regional Hospital, Carroll

51503

Alegent Health Mercy Hospital, Council Bluffs

53066

ProHealth Oconomowoc Memorial Hospital, Oconomowoc

53149

ProHealth D N Greenwald Center, Mukwonago

53188

ProHealth Waukesha Memorial Hospital, Waukesha

UW Cancer Center at ProHealth Care, Waukesha

54017

Cancer Center of Western Wisconsin, New Richmond

54911

ThedaCare Regional Cancer Center, Appleton

55008

Cambridge Medical Center, Cambridge

55082

Lakeview Hospital, Stillwater

55092

Fairview Lakes Medical Center, Wyoming

55101

Regions Hospital, Saint Paul

55102

United Hospital, Saint Paul

55109

Minnesota Oncology Hematology PA-Maplewood, Maplewood

Saint John's Hospital - Healtheast, Maplewood

55125

Minnesota Oncology Hematology PA-Woodbury, Woodbury

55337

Fairview Ridges Hospital, Burnsville

Minnesota Oncology - Burnsville, Burnsville

55362

Monticello Cancer Center, Monticello

55369

Fairview Clinics and Surgery Center Maple Grove, Maple Grove

55371

Fairview Northland Medical Center, Princeton

55379

Saint Francis Regional Medical Center, Shakopee

55387

Ridgeview Medical Center, Waconia

55407

Abbott-Northwestern Hospital, Minneapolis

55415

Hennepin County Medical Center, Minneapolis

55416

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park

55422

North Memorial Medical Health Center, Robbinsdale

55432

Unity Hospital, Fridley

55433

Mercy Hospital, Coon Rapids

55435

Fairview Southdale Hospital, Edina

55454

Health Partners Inc, Minneapolis

55905

Mayo Clinic in Rochester, Rochester

56073

New Ulm Medical Center, New Ulm

56201

Rice Memorial Hospital, Willmar

56601

Sanford Joe Lueken Cancer Center, Bemidji

57104

Sanford Cancer Center Oncology Clinic, Sioux Falls

58122

Sanford Broadway Medical Center, Fargo

Sanford Roger Maris Cancer Center, Fargo

58501

Sanford Bismarck Medical Center, Bismarck

60504

Rush - Copley Medical Center, Aurora

60560

Rush-Copley Healthcare Center, Yorkville

61021

Illinois CancerCare-Dixon, Dixon

61350

Illinois CancerCare-Ottawa Clinic, Ottawa

61354

Illinois CancerCare-Peru, Peru

Valley Radiation Oncology, Peru

61356

Illinois CancerCare-Princeton, Princeton

61401

Illinois CancerCare-Galesburg, Galesburg

Western Illinois Cancer Treatment Center, Galesburg

61443

Illinois CancerCare-Kewanee Clinic, Kewanee

61455

Illinois CancerCare-Macomb, Macomb

61520

Illinois CancerCare-Canton, Canton

61530

Illinois CancerCare-Eureka, Eureka

61554

Illinois CancerCare-Pekin, Pekin

61571

Illinois CancerCare - Washington, Washington

61615

Illinois CancerCare-Peoria, Peoria

61636

Methodist Medical Center of Illinois, Peoria

61704

Illinois CancerCare-Bloomington, Bloomington

61801

Carle Cancer Center, Urbana

The Carle Foundation Hospital, Urbana

61832

Carle at The Riverfront, Danville

61938

Carle Physician Group-Mattoon/Charleston, Mattoon

62269

Cancer Care Center of O'Fallon, O'Fallon

62321

Illinois CancerCare-Carthage, Carthage

62401

Carle Physician Group-Effingham, Effingham

Crossroads Cancer Center, Effingham

62526

Cancer Care Specialists of Illinois - Decatur, Decatur

Decatur Memorial Hospital, Decatur

62702

Southern Illinois University School of Medicine, Springfield

Springfield Clinic, Springfield

62781

Springfield Memorial Hospital, Springfield

62801

Centralia Oncology Clinic, Centralia

62902

Memorial Hospital of Carbondale, Carbondale

62918

SIH Cancer Institute, Carterville

63080

Missouri Baptist Sullivan Hospital, Sullivan

63127

BJC Outpatient Center at Sunset Hills, Sunset Hills

63131

Missouri Baptist Medical Center, St Louis

63141

Mercy Hospital Saint Louis, St Louis

63640

Parkland Health Center - Farmington, Farmington

63670

Sainte Genevieve County Memorial Hospital, Sainte Genevieve

63703

Saint Francis Medical Center, Cape Girardeau

Southeast Cancer Center, Cape Girardeau

65109

MU Health Care Goldschmidt Cancer Center, Jefferson City

67208

Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita

67214

Ascension Via Christi Hospitals Wichita, Wichita

Cancer Center of Kansas - Wichita, Wichita

68046

Midlands Community Hospital, Papillion

68122

Alegent Health Immanuel Medical Center, Omaha

68124

Alegent Health Bergan Mercy Medical Center, Omaha

68130

Alegent Health Lakeside Hospital, Omaha

68131

Creighton University Medical Center, Omaha

68510

Saint Elizabeth Regional Medical Center, Lincoln

68803

Nebraska Cancer Specialists/Oncology Hematology West PC, Grand Island

68847

CHI Health Good Samaritan, Kearney

71913

CHI Saint Vincent Cancer Center Hot Springs, Hot Springs

73104

University of Oklahoma Health Sciences Center, Oklahoma City

74146

Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa

77802

Saint Joseph Regional Cancer Center, Bryan

80122

Littleton Adventist Hospital, Littleton

80138

Parker Adventist Hospital, Parker

80210

AdventHealth Porter, Denver

80228

Saint Anthony Hospital, Lakewood

80501

Longmont United Hospital, Longmont

Rocky Mountain Cancer Centers-Longmont, Longmont

80907

Penrose-Saint Francis Healthcare, Colorado Springs

Rocky Mountain Cancer Centers-Penrose, Colorado Springs

81004

Saint Mary Corwin Medical Center, Pueblo

81301

Mercy Medical Center, Durango

Southwest Oncology PC, Durango

85004

Cancer Center at Saint Joseph's, Phoenix

93401

Pacific Central Coast Health Center-San Luis Obispo, San Luis Obispo

93420

Mission Hope Medical Oncology - Arroyo Grande, Arroyo Grande

93444

Mission Hope Medical Oncology - Santa Maria, Santa Maria

98003

Saint Francis Hospital, Federal Way

98022

Saint Elizabeth Hospital, Enumclaw

98166

Highline Medical Center-Main Campus, Burien

98383

Saint Michael Cancer Center, Silverdale

98405

Franciscan Research Center-Northwest Medical Plaza, Tacoma

98499

Saint Clare Hospital, Lakewood

50266-7700

Methodist West Hospital, West Des Moines

02111

Tufts Medical Center, Boston

45005-1066

Atrium Medical Center-Middletown Regional Hospital, Franklin

17033-0850

Penn State Milton S Hershey Medical Center, Hershey

57117-5134

Sanford USD Medical Center - Sioux Falls, Sioux Falls

00927

Centro Comprensivo de Cancer de UPR, San Juan

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH