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

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.


What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • STEP 0: PRE-REGISTRATION
  • Patients must be previously diagnosed with multiple myeloma and be on lenalidomide maintenance with >= 10 mg daily dose for at least 10 months and no more than 15 months after an early autologous stem cell transplantation (SCT =< 12 months of diagnosis). Patients should not be off lenalidomide maintenance therapy for more than 30 days prior to start of treatment on protocol
  • Patients must be able to undergo a diagnostic bone marrow aspirate following registration to step 0
    • NOTE: A bone marrow aspirate specimen must be submitted to Mayo Clinic Hematology Laboratory for central assessment of minimal residual disease (MRD) status to confirm patient's eligibility for step 1 randomization. Mayo Clinic will forward results =< within three (3) business days of receipt of the bone marrow specimen to the submitting institution
  • Patients must not have primary refractory or progressive disease on a proteasome inhibitor-based regimen during induction therapy prior to stem cell transplant
  • Patients must not be on other concurrent chemotherapy, or any ancillary therapy considered investigational
    • NOTE: Bisphosphonates are considered to be supportive care rather than therapy and are allowed while on protocol treatment
  • Patients must not have uncontrolled psychiatric illness or social situations that would limit compliance with study requirements
  • Patients must not have another malignancy requiring treatment or have received treatment within 2 years before pre-registration or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
  • Patients must have been able to maintain at least 10 mg dose of lenalidomide without growth factor support
  • 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
  • Patients must not be off lenalidomide maintenance therapy for more than 30 days prior to start of treatment on 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) are required to be 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 have an Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • 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
  • Patients must agree to register into the mandatory Risk Evaluation and Mitigation Strategies (REMS) program and be willing and able to comply with the requirements of REMS
  • Women must not be pregnant due to potential harm to the fetus from ixazomib and lenalidomide. All females of childbearing potential (FCBP) 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. FCBP must also agree to ongoing pregnancy testing while on treatment. A female of childbearing potential is any woman, 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)
  • Females of childbearing potential (FCBP) 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. Women 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 FCBP while participating in the study and for 90 days after the last dose of protocol treatment even if they have had a successful vasectomy. Men 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. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment

Additional Trial Information

Phase 3

Enrollment: 510 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

Cancer Center at St. Joseph's

Phoenix, AZ

Temporarily Suspended

Arkansas

CHI St. Vincent Cancer Center Hot Springs

Hot Springs, AR

Temporarily Suspended

California

Mission Hope Medical Oncology

Arroyo Grande, CA

Temporarily Suspended

Pacific Central Coast Health Center - San Luis Obispo

San Luis Obispo, CA

Temporarily Suspended

Mission Hope Cancer Center

Santa Maria, CA

Temporarily Suspended

Colorado

Littleton Adventist Hospital

Centennial, CO

Temporarily Suspended

Penrose-Saint Francis Healthcare

Colorado Springs, CO

Temporarily Suspended

Rocky Mountain Cancer Center Colorado Springs

Colorado Springs, CO

Temporarily Suspended

Porter Adventist Hospital

Denver, CO

Temporarily Suspended

Mercy Medical Center

Durango, CO

Temporarily Suspended

Southwest Oncology PC

Durango, CO

Temporarily Suspended

Saint Anthony Hospital

Lakewood, CO

Temporarily Suspended

Longmont United Hospital

Longmont, CO

Temporarily Suspended

Rocky Mountain Cancer Center Longmont

Longmont, CO

Temporarily Suspended

Parker Adventist Hospital

Parker, CO

Temporarily Suspended

Saint Mary Corwin Medical Center

Pueblo, CO

Temporarily Suspended

Illinois

Rush - Copley Medical Center

Aurora, IL

Temporarily Suspended

Illinois CancerCare (Bloomington)

Bloomington, IL

Open and Accepting

Illinois CancerCare (Canton)

Canton, IL

Open and Accepting

Memorial Hospital of Carbondale

Carbondale, IL

Temporarily Suspended

SIH Cancer Institute

Carterville, IL

Temporarily Suspended

Illinois CancerCare (Carthage)

Carthage, IL

Open and Accepting

Centralia Oncology Clinic

Centralia, IL

Open and Accepting

Carle Foundation Hospital (Vermilion)

Danville, IL

Open and Accepting

Cancer Care Specialists of Central Illinois

Decatur, IL

Open and Accepting

Decatur Memorial Hospital

Decatur, IL

Temporarily Suspended

Illinois CancerCare-Dixon

Dixon, IL

Open and Accepting

Crossroads Cancer Center

Effingham, IL

Open and Accepting

Carle Foundation Hospital (Effingham)

Effingham, IL

Open and Accepting

Illinois CancerCare (Eureka)

Eureka, IL

Open and Accepting

Illinois CancerCare (Galesburg)

Galesburg, IL

Open and Accepting

Western Illinois Cancer Treatment Center

Galesburg, IL

Temporarily Suspended

Illinois CancerCare (Kewanee)

Kewanee, IL

Open and Accepting

Illinois CancerCare (Macomb)

Macomb, IL

Open and Accepting

Carle Foundation Hospital (Mattoon)

Mattoon, IL

Open and Accepting

Cancer Care Center of O'Fallon

O'Fallon, IL

Open and Accepting

Illinois CancerCare (Ottawa)

Ottawa, IL

Open and Accepting

Illinois CancerCare (Pekin)

Pekin, IL

Open and Accepting

Illinois CancerCare

Peoria, IL

Open and Accepting

Methodist Medical Center of Illinois

Peoria, IL

Temporarily Suspended

Illinois CancerCare (Peru)

Peru, IL

Open and Accepting

Valley Radiation Oncology

Peru, IL

Temporarily Suspended

Illinois CancerCare (Princeton)

Princeton, IL

Open and Accepting

Southern Illinois University School of Medicine

Springfield, IL

Open and Accepting

Springfield Clinic

Springfield, IL

Open and Accepting

Memorial Medical Center

Springfield, IL

Temporarily Suspended

Carle Foundation Hospital

Urbana, IL

Temporarily Suspended

Rush - Copley Healthcare Center

Yorkville, IL

Temporarily Suspended

Iowa

Mary Greeley Medical Center

Ames, IA

Open and Accepting

McFarland Clinic PC

Ames, IA

Open and Accepting

McFarland Clinic PC (Boone)

Boone, IA

Open and Accepting

Medical Oncology and Hematology Associates (West Des Moines)

Clive, IA

Temporarily Suspended

Mercy Cancer Center (West Lakes)

Clive, IA

Temporarily Suspended

Alegent Health Mercy Hospital

Council Bluffs, IA

Temporarily Suspended

Greater Regional Medical Center

Creston, IA

Temporarily Suspended

Iowa Oncology Research Association CCOP

Des Moines, IA

Open and Accepting

Iowa Methodist Medical Center

Des Moines, IA

Open and Accepting

Medical Oncology and Hematology Associates (Des Moines)

Des Moines, IA

Open and Accepting

Broadlawns Medical Center

Des Moines, IA

Open and Accepting

Iowa Lutheran Hospital

Des Moines, IA

Temporarily Suspended

Medical Oncology and Hematology Associates (Laurel)

Des Moines, IA

Temporarily Suspended

Mercy Medical Center (Des Moines)

Des Moines, IA

Temporarily Suspended

McFarland Clinic PC (Trinity Cancer Center)

Fort Dodge, IA

Open and Accepting

Trinity Regional Medical Center

Fort Dodge, IA

Temporarily Suspended

McFarland Clinic PC (Jefferson)

Jefferson, IA

Open and Accepting

McFarland Clinic PC (Marshalltown)

Marshalltown, IA

Open and Accepting

Methodist West Hospital

West Des Moines, IA

Open and Accepting

Mercy Medical Center (West Lakes)

West Des Moines, IA

Temporarily Suspended

Kentucky

Flaget Memorial Hospital

Bardstown, KY

Temporarily Suspended

Commonwealth Cancer Center (Corbin)

Corbin, KY

Temporarily Suspended

Saint Joseph Hospital

Lexington, KY

Temporarily Suspended

Saint Joseph Hospital East

Lexington, KY

Temporarily Suspended

Saint Joseph (London)

London, KY

Temporarily Suspended

Jewish Hospital

Louisville, KY

Temporarily Suspended

Saints Mary and Elizabeth Hospital

Louisville, KY

Temporarily Suspended

Jewish Hospital Medical Center Northeast

Louisville, KY

Temporarily Suspended

Jewish Hospital Medical Center South

Shepherdsville, KY

Open and Accepting

Minnesota

Fairview Ridges Hospital

Burnsville, MN

Temporarily Suspended

Minnesota Oncology (Burnsville)

Burnsville, MN

Temporarily Suspended

Cambridge Medical Center

Cambridge, MN

Temporarily Suspended

Mercy Hospital

Coon Rapids, MN

Temporarily Suspended

Fairview Southdale Hospital

Edina, MN

Temporarily Suspended

Unity Hospital

Fridley, MN

Temporarily Suspended

Minnesota Oncology and Hematology PA (Maplewood)

Maplewood, MN

Temporarily Suspended

Saint John's Hospital - Healtheast

Maplewood, MN

Temporarily Suspended

Abbott-Northwestern Hospital

Minneapolis, MN

Temporarily Suspended

Hennepin County Medical Center

Minneapolis, MN

Temporarily Suspended

Health Partners Inc.

Minneapolis, MN

Temporarily Suspended

Monticello Cancer Center

Monticello, MN

Temporarily Suspended

New Ulm Medical Center

New Ulm, MN

Temporarily Suspended

Fairview Northland Medical Center

Princeton, MN

Temporarily Suspended

North Memorial Medical Health Center

Robbinsdale, MN

Temporarily Suspended

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting

Saint Francis Regional Medical Center

Shakopee, MN

Temporarily Suspended

Park Nicollet Clinic (Saint Louis Park)

St. Louis Park, MN

Temporarily Suspended

Regions Hospital

St. Paul, MN

Temporarily Suspended

United Hospital

St. Paul, MN

Temporarily Suspended

Lakeview Hospital

Stillwater, MN

Temporarily Suspended

Ridgeview Medical Center

Waconia, MN

Temporarily Suspended

Rice Memorial Hospital

Willmar, MN

Temporarily Suspended

Minnesota Oncology and Hematology PA (Woodbury)

Woodbury, MN

Temporarily Suspended

Fairview Lakes Medical Center

Wyoming, MN

Temporarily Suspended

Missouri

Saint Francis Medical Center (Cape Girardeau)

Cape Girardeau, MO

Open and Accepting

Southeast Cancer Center

Cape Girardeau, MO

Temporarily Suspended

Parkland Health Center (Farmington)

Farmington, MO

Temporarily Suspended

Capital Region Medical Center (Goldschmidt Cancer Center)

Jefferson City, MO

Temporarily Suspended

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, MO

Temporarily Suspended

Missouri Baptist Medical Cancer Center

St. Louis, MO

Temporarily Suspended

Missouri Baptist Sullivan Hospital

Sullivan, MO

Temporarily Suspended

Missouri Baptist Outpatient Center (Sunset Hills)

Sunset Hills, MO

Temporarily Suspended

Nebraska

CHI Health Saint Francis Medical Center

Grand Island, NE

Temporarily Suspended

CHI Health Good Samaritan Hospital

Kearney, NE

Temporarily Suspended

Saint Elizabeth Regional Medical Center

Lincoln, NE

Temporarily Suspended

Alegent Health Immanuel Medical Center

Omaha, NE

Temporarily Suspended

Alegent Health Bergan Mercy Medical Center

Omaha, NE

Temporarily Suspended

Alegent Health Lakeside Hospital

Omaha, NE

Temporarily Suspended

CHI Health Creighton University Medical Center

Omaha, NE

Temporarily Suspended

CHI Health Midlands

Papillion, NE

Temporarily Suspended

Ohio

Bethesda North Hospital

Blue Ash, OH

Temporarily Suspended

TriHealth Cancer Institute (Good Samaritan Hospital)

Cincinnati, OH

Temporarily Suspended

Dublin Methodist Hospital

Dublin, OH

Temporarily Suspended

TriHealth Cancer Institute (Anderson)

Forestville, OH

Temporarily Suspended

Mount Carmel Grove City Hospital

Grove City, OH

Temporarily Suspended

Saint Rita's Medical Center

Lima, OH

Temporarily Suspended

OhioHealth Mansfield Hospital

Mansfield, OH

Temporarily Suspended

Newark Radiation Oncology

Newark, OH

Temporarily Suspended

Saint Vincent Mercy Medical Center

Toledo, OH

Temporarily Suspended

Mercy Saint Anne Hospital

Toledo, OH

Temporarily Suspended

TriHealth Cancer Institute (Westside)

White Oak, OH

Temporarily Suspended

Oklahoma

Oklahoma Cancer Specialists and Research Institute (Tulsa)

Tulsa, OK

Temporarily Suspended

Texas

St. Joseph Regional Cancer Center

Bryan, TX

Temporarily Suspended

Washington

Harrison Medical Center

Bremerton, WA

Temporarily Suspended

Highline Medical Center (Main Campus)

Burien, WA

Temporarily Suspended

Saint Elizabeth Hospital

Enumclaw, WA

Temporarily Suspended

Saint Francis Hospital

Federal Way, WA

Temporarily Suspended

Saint Clare Hospital - CHI Franciscan Health

Lakewood, WA

Temporarily Suspended

CHI Franciscan Health (Northwest Medical Plaza)

Tacoma, WA

Temporarily Suspended

Wisconsin

Mayo Clinic Health System - Franciscan Healthcare

La Crosse , WI

Temporarily Suspended

D. N. Greenwald Center

Mukwonago, WI

Temporarily Suspended

Cancer Center of Western Wisconsin

New Richmond, WI

Open and Accepting

Oconomowoc Memorial Hospital-ProHealth Care Inc

Oconomowoc, WI

Temporarily Suspended

Waukesha Memorial Hospital - ProHealth Care

Waukesha, WI

Temporarily Suspended

UW Cancer Center at ProHealth Care

Waukesha, WI

Temporarily Suspended
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