AzTrials
AzTrials

Amorphous, Eosinophilic, and Acellular DepositPhase 2NCT03499808

S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis

A Phase 2 study testing Isatuximab and Laboratory Biomarker Analysis in people with Amorphous, Eosinophilic, and Acellular Deposit and Constipation, run by SWOG Cancer Research Network at 345 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This phase II trial studies how well isatuximab works in treating patients with primary amyloidosis that has come back or does not respond to treatment. Monoclonal antibodies, such as isatuximab, may interfere with the ability of cancer cells to grow and spread. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Isatuximab and Laboratory Biomarker Analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
345 sitesUnited States
Study dates
6 Jun 2018to 19 Sep 2023
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must have relapsed or refractory primary systemic AL amyloidosis, histologically-confirmed by positive Congo red stain with green by birefringence on polarized light microscopy, OR characteristic appearance by electron microscopy AND confirmatory AL amyloid typing (mass spectrometry-based proteomic analysis or immunofluorescence)
  • Patient must have measurable disease within 28 days prior to registration; serum beta2 microglobulin, serum quantitative immunoglobulins (immunoglobulin [Ig]G, IgA, and IgM), serum free kappa and lambda, and serum protein electrophoresis (SPEP) with M-protein quantification must be obtained within 14 days prior to registration
  • Patient must demonstrate a difference in the involved serum free light chains (kappa or lambda) versus the uninvolved serum free light chain of >= 4.5 mg/dL within 14 days prior to registration
  • Patient must have objective organ involvement defined by ONE (or more) of the following; all disease for involved organs must be assessed and documented on the AL baseline tumor assessment form
  • Kidney: albuminuria greater than or equal to 500 mg per day on a 24-hour urine specimen within 35 days prior to registration, OR prior kidney biopsy (at time of diagnosis) showing amyloid deposition
  • Heart: mean left ventricular wall thickness on echocardiogram greater than or equal to 12 mm in the absence of hypertension or valvular heart disease, OR N-terminal fragment brain natriuretic protein (NT-pro) brain natriuretic peptide (BNP) greater than 332 ng/mL provided that patient does not have impaired renal function (as defined by calculated creatinine clearance less than 25 mL/min) within 14 days prior to registration, OR prior cardiac biopsy (at time of diagnosis) showing amyloid deposition with past documented or presently noted clinical symptoms and signs supportive of a diagnosis of heart failure in the absence of an alternative explanation for heart failure
Show all 40Show fewer
  • Liver: hepatomegaly (total liver span > 15 cm) as demonstrated by computed tomography (CT) or magnetic resonance imaging (MRI) within 35 days prior to registration OR elevated alkaline phosphatase (ALP) greater than 1.5 times the upper limit of normal within 14 days prior to registration, OR prior liver biopsy (at time of diagnosis) showing amyloid deposition
  • Gastrointestinal tract: prior biopsy showing amyloid deposition AND symptoms such as GI bleeding or persistent diarrhea (> 4 loose stools/day on most days over a consecutive 28-day period)
  • Autonomic or peripheral nervous system: orthostatic blood pressure, symptoms of nausea, early satiety, diarrhea or constipation, abnormal sensory and/or motor findings on neurologic exam, or gastric atony by gastric emptying scan; Note: pulse and blood pressure must be recorded with the patient supine (lying down), and then again after at least 1 minute, but less than 3 minutes of standing; this assessment must be repeated on 2 separate occasions (at least 1 day apart; e.g. day -3 and day -1) within a 28-day screening period
  • Soft tissue: macroglossia, or soft tissue deposits (including lymphadenopathy, recurrent peri-orbital purpura, peri-articular, skin or other soft tissue) requiring therapy
  • Patients must not have active symptomatic multiple myeloma, as defined by 2015 International Myeloma Working Group (IMWG) criteria (hypercalcemia, renal failure, anemia, and bone [CRAB] criteria; bone marrow plasmacytosis > 60%); kappa: lambda ratio > 100 is acceptable only if the clinical symptoms and sign are attributable only to amyloidosis and not multiple myeloma (hemoglobin [Hgb] < 8 g/dL)
  • Patient must be relapsed or refractory to at least one prior line of therapy (such as: transplant, radiation, or chemotherapy)
  • Patients must have completed other systemic therapy >= 14 days or investigational drug >= 28 days prior to registration, surgery (other than biopsies) >= 21 days prior to registration, and any autologous stem cell transplant (ASCT) >= 100 days prior to registration
  • Patients must not have received any or supplements which have been known to have some anti-amyloidogenic effect (such as: doxycycline; curcumin; prednisone; dexamethasone; epigallocatechin gallate [EGCG]) within 14 days prior to registration
  • Patients must not have any known allergies to isatuximab or other monoclonal antibody therapies
  • Patients must not have received daratumumab within 56 days prior to registration nor have been refractory to daratumumab
  • Patients must not be eligible for autologous stem cell transplantation
  • Patients must have a complete medical history and physical exam within 14 days prior to registration
  • Within 14 days prior to registration: Total bilirubin =< 2.0 x IULN (institutional upper limit of the norm) AND
  • Within 14 days prior to registration: Serum glutamic-oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) and serum glutamate pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) =< 4.0 x IULN
  • Creatinine clearance (CrCl) >= 25 mL/min, as measured by a 24-hour urine collection or as estimated by the Cockcroft and Gault formula; the serum creatinine value used in the calculation must have been obtained within 35 days prior to registration
  • Patients must have bone marrow aspirate, including fluorescence in situ hybridization (FISH) (including: del 17p; t11;14; t4;14, t14;16; and del 13q) and cytogenetic testing (normal ? XY; and all abnormalities) within 35 days prior to registration; central pathology analysis will not be required, however the local pathology report and FISH/cytogenetic data must be submitted in Medidata RAVE
  • Within 14 days prior to registration: Absolute neutrophil count (ANC) >= 1,000 cells/mcl without growth factor support, AND
  • Within 14 days prior to registration: Platelets >= 75,000 cells/mcl
  • Patients must have hemoglobin >= 8 g/dL within 14 days prior to registration; patients may have received transfusion if greater than 7 days prior to registration
  • New York Heart Association (NYHA) < class IV heart failure
  • Left ventricular ejection fraction (LVEF) by echocardiogram (ECHO) >= 35% within 35 days prior to registration; and
  • NT-proBNP =< 8500 ng/L within 14 days prior to registration
  • Patients must have a Zubrod performance status =< 2
  • Patients must not have any clinically significant uncontrolled systemic illness, including but not limited to uncontrolled, active infection requiring intravenous antibiotics, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmias, uncontrolled hypertension, or uncontrolled diabetes mellitus
  • Uncontrolled diabetes: patients who have a diagnosis of diabetes must have an glycosylated hemoglobin (HbA1C) < 7% within 14 days prior to registration; the same criterion will be used in patients with confirmed diagnosis of diabetes mellitus who have been on a stable dietary or therapeutic regimen for this condition in the last three months
  • Uncontrolled blood pressure and hypertension: all blood pressure measurements within the 14 days prior to registration must be systolic blood pressure (SBP) =< 160 and diastolic blood pressure (DBP) =< 100; an exception can be made by a healthcare provider for a patient with a single blood pressure elevation who upon rechecking has a normal blood pressure
  • Females of childbearing potential must have a negative baseline pregnancy test within 14 days prior to registration; this may be either a serum or urine pregnancy test, with a sensitivity of at least 50 mIU/mL; females of childbearing potential (FCBP) must also agree: (1) to have a pregnancy test prior to the start of each treatment cycle and (2) to either commit to continued abstinence from heterosexual intercourse or to use effective contraception while receiving study drug and for at least 12 weeks after receiving the last dose of study drug; females are considered to be of ?childbearing potential? if they have had menses at any time in the preceding 24 consecutive months; in addition to routine contraceptive methods, ?effective contraception? also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, she is responsible for beginning contraceptive measures
  • Patients with evidence of hepatitis B virus (HBV) are eligible provided there is minimal hepatic injury and the patient has undetectable HBV on suppressive HBV therapy; patient must be willing to maintain adherence to HBV therapy; patients with previously treated and eradicated hepatitis C virus (HCV) who have minimal hepatic injury are eligible
  • Patients who are known to be human immunodeficiency virus (HIV)-positive at registration are eligible if at time of registration they meet all other protocol eligibility criteria in addition to the following:
  • Patient has undetectable HIV viral load by standard polymerase chain reaction (PCR) clinical assay
  • Patient is willing to maintain adherence to combination antiretroviral therapy
  • Patient has no history of acquired immunodeficiency syndrome (AIDS) defining condition (other than CD4 cell count < 200 mm^3)
  • Patient is otherwise likely to have a near normal lifespan if not for the presence of relapsed/refractory amyloid
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least two years

Who cannot join

None listed.

Trial locations and contacts

345 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Saint Alphonsus Medical Center-Baker City

    Baker City, Oregon, 97814

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Flaget Memorial Hospital

    Bardstown, Kentucky, 40004

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Waldo County General Hospital

    Belfast, Maine, 04915

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford

    Biddeford, Maine, 04005

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Harrison Medical Center

    Bremerton, Washington, 98310

  • Lafayette Family Cancer Center-EMMC

    Brewer, Maine, 04412

  • United Hospital Center

    Bridgeport, West Virginia, 26330

  • IHA Hematology Oncology Consultants-Brighton

    Brighton, Michigan, 48114

  • Saint Joseph Mercy Brighton

    Brighton, Michigan, 48114

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • IHA Hematology Oncology Consultants-Canton

    Canton, Michigan, 48188

  • Saint Joseph Mercy Canton

    Canton, Michigan, 48188

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • Caro Cancer Center

    Caro, Michigan, 48723

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Memorial Hospital

    Chattanooga, Tennessee, 37404

  • IHA Hematology Oncology Consultants-Chelsea

    Chelsea, Michigan, 48118

  • Saint Joseph Mercy Chelsea

    Chelsea, Michigan, 48118

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wyoming, 82001

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Oncology and Hematology Care Southeast

    Clackamas, Oregon, 97015

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Medical Center

    Coeur d'Alene, Idaho, 83814

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Carle on Vermilion

    Danville, Illinois, 61832

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Denver Health Medical Center

    Denver, Colorado, 80204

  • National Jewish Health-Main Campus

    Denver, Colorado, 80206

  • The Women's Imaging Center

    Denver, Colorado, 80209

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • SCL Health Saint Joseph Hospital

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Rose Medical Center

    Denver, Colorado, 80220

  • Western Surgical Care

    Denver, Colorado, 80220

  • Smilow Cancer Hospital-Derby Care Center

    Derby, Connecticut, 06418

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236

  • Mercy Medical Center

    Durango, Colorado, 81301

  • Southwest Oncology PC

    Durango, Colorado, 81301

  • Great Lakes Cancer Management Specialists-Doctors Park

    East China Township, Michigan, 48054

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

  • Comprehensive Cancer Care and Research Institute of Colorado LLC

    Englewood, Colorado, 80113

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Saint Elizabeth Hospital

    Enumclaw, Washington, 98022

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Smilow Cancer Hospital Care Center-Fairfield

    Fairfield, Connecticut, 06824

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Genesee Cancer and Blood Disease Treatment Center

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Mountain States Tumor Institute - Fruitland

    Fruitland, Idaho, 83619

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

  • Mountain Blue Cancer Care Center

    Golden, Colorado, 80401

  • National Jewish Health-Western Hematology Oncology

    Golden, Colorado, 80401

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81501

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • East Carolina University

    Greenville, North Carolina, 27834

  • Academic Hematology Oncology Specialists

    Grosse Pointe Woods, Michigan, 48236

  • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

    Grosse Pointe Woods, Michigan, 48236

  • Michigan Breast Specialists-Grosse Pointe Woods

    Grosse Pointe Woods, Michigan, 48236

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Lehigh Valley Hospital-Hazleton

    Hazleton, Pennsylvania, 18201

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Pulmonary Medicine Center of Chattanooga-Hixson

    Hixson, Tennessee, 37343

  • CHI Saint Vincent Cancer Center Hot Springs

    Hot Springs, Arkansas, 71913

  • Centerpoint Medical Center LLC

    Independence, Missouri, 64057

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Onslow Memorial Hospital

    Jacksonville, North Carolina, 28546

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

  • Capital Region Southwest Campus

    Jefferson City, Missouri, 65109

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Heartland Hematology and Oncology

    Kearney, Nebraska, 68845

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Providence Regional Cancer System-Lacey

    Lacey, Washington, 98503

  • Good Samaritan Medical Center

    Lafayette, Colorado, 80026

  • Rocky Mountain Cancer Centers-Lakewood

    Lakewood, Colorado, 80228

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Saint Clare Hospital

    Lakewood, Washington, 98499

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Kansas Institute of Medicine Cancer and Blood Center

    Lenexa, Kansas, 66219

  • Minimally Invasive Surgery Hospital

    Lenexa, Kansas, 66219

  • Saint Joseph Radiation Oncology Resource Center

    Lexington, Kentucky, 40504

  • Saint Joseph Hospital East

    Lexington, Kentucky, 40509

  • Saint Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120

  • Littleton Adventist Hospital

    Littleton, Colorado, 80122

  • Hope Cancer Clinic

    Livonia, Michigan, 48154

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Saint Joseph London

    London, Kentucky, 40741

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • Rocky Mountain Cancer Centers-Longmont

    Longmont, Colorado, 80501

  • PeaceHealth Saint John Medical Center

    Longview, Washington, 98632

  • Jewish Hospital

    Louisville, Kentucky, 40202

  • Saints Mary and Elizabeth Hospital

    Louisville, Kentucky, 40215

  • Jewish Hospital Medical Center Northeast

    Louisville, Kentucky, 40245

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Great Lakes Cancer Management Specialists-Macomb Medical Campus

    Macomb, Michigan, 48044

  • Michigan Breast Specialists-Macomb Township

    Macomb, Michigan, 48044

  • Fairview Maple Grove Medical Center

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Saint Mary's Oncology/Hematology Associates of Marlette

    Marlette, Michigan, 48453

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • WVUH-Berkely Medical Center

    Martinsburg, West Virginia, 25401

  • Fremont - Rideout Cancer Center

    Marysville, California, 95901

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Marjorie Weinberg Cancer Center at Loyola-Gottlieb

    Melrose Park, Illinois, 60160

  • Idaho Urologic Institute-Meridian

    Meridian, Idaho, 83642

  • Saint Luke's Mountain States Tumor Institute - Meridian

    Meridian, Idaho, 83642

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Community Medical Hospital

    Missoula, Montana, 59804

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

  • Saint Alphonsus Medical Center-Nampa

    Nampa, Idaho, 83686

  • Saint Luke's Mountain States Tumor Institute - Nampa

    Nampa, Idaho, 83686

  • Smilow Cancer Center/Yale-New Haven Hospital

    New Haven, Connecticut, 06510

  • Yale University

    New Haven, Connecticut, 06520

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • Yale-New Haven Hospital North Haven Medical Center

    North Haven, Connecticut, 06473

  • Stephens Memorial Hospital

    Norway, Maine, 04268

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Hematology and Oncology Consultants PC

    Omaha, Nebraska, 68122

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Alegent Health Lakeside Hospital

    Omaha, Nebraska, 68130

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • Saint Alphonsus Medical Center-Ontario

    Ontario, Oregon, 97914

  • Memorial GYN Plus

    Ooltewah, Tennessee, 37363

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Smilow Cancer Hospital-Orange Care Center

    Orange, Connecticut, 06477

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Saint Luke's South Hospital

    Overland Park, Kansas, 66213

  • Midlands Community Hospital

    Papillion, Nebraska, 68046

  • Parker Adventist Hospital

    Parker, Colorado, 80138

  • Rocky Mountain Cancer Centers-Parker

    Parker, Colorado, 80138

  • Camden Clark Medical Center

    Parkersburg, West Virginia, 26101

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • 21st Century Oncology-Pontiac

    Pontiac, Michigan, 48341

  • Hope Cancer Center

    Pontiac, Michigan, 48341

  • Newland Medical Associates-Pontiac

    Pontiac, Michigan, 48341

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Kootenai Cancer Center

    Post Falls, Idaho, 83854

  • Harrison HealthPartners Hematology and Oncology-Poulsbo

    Poulsbo, Washington, 98370

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Fairview Northland Medical Center

    Princeton, Minnesota, 55371

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004

  • Rocky Mountain Cancer Centers - Pueblo

    Pueblo, Colorado, 81008

  • Saint Charles Health System-Redmond

    Redmond, Oregon, 97756

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • Great Lakes Cancer Management Specialists-Rochester Hills

    Rochester Hills, Michigan, 48309

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Ascension Saint Mary's Hospital

    Saginaw, Michigan, 48601

  • Oncology Hematology Associates of Saginaw Valley PC

    Saginaw, Michigan, 48604

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64507

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

  • Kootenai Cancer Clinic

    Sandpoint, Idaho, 83864

  • MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford

    Sanford, Maine, 04073

  • Pacific Gynecology Specialists

    Seattle, Washington, 98104

  • Swedish Medical Center-Ballard Campus

    Seattle, Washington, 98107

  • Kaiser Permanente Washington

    Seattle, Washington, 98112

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122-4307

  • Swedish Medical Center-Cherry Hill

    Seattle, Washington, 98122-5711

  • PeaceHealth United General Medical Center

    Sedro-Woolley, Washington, 98284

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Providence Regional Cancer System-Shelton

    Shelton, Washington, 98584

  • Jewish Hospital Medical Center South

    Shepherdsville, Kentucky, 40165

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Memorial Medical Center

    Springfield, Illinois, 62781

Other trials in United States

About this study

Official title: A Phase II Study of Isatuximab (SAR650984) (NSC-795145) for Patients With Previously Treated AL Amyloidosis

This phase II trial studies how well isatuximab works in treating patients with primary amyloidosis that has come back or does not respond to treatment. Monoclonal antibodies, such as isatuximab, may interfere with the ability of cancer cells to grow and spread.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the efficacy as measured by the confirmed overall hematologic response rate (partial response or better) of isatuximab in relapsed/refractory systemic light chain (AL) amyloidosis.

SECONDARY OBJECTIVES:

  1. To evaluate toxicities in the treatment of relapsed/refractory AL amyloidosis with isatuximab.

II. To evaluate time to hematologic response. III. To evaluate duration of response. IV. To evaluate progression-free survival (PFS). V. To evaluate overall survival (OS).

TERTIARY OBJECTIVES:

  1. To evaluate efficacy of isatuximab in relapsed/refractory immunoglobulin amyloid light chain (AL) amyloidosis as measured by organ specific response rates (cardiac, renal, gastrointestinal [GI], liver, soft tissue, nerve), in the subset of patients that can be evaluated for organ response.

II. To evaluate time to organ response in the subset of patients that can be evaluated for organ response.

OUTLINE:

Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up within 30 days and then every at least every 6 months for up to 4 years.

Being tested
Isatuximab, Laboratory Biomarker Analysis
Medical subject headings
Constipation, Diarrhea, Gastrointestinal Hemorrhage, Hepatomegaly, Lymphadenopathy, Macroglossia, Nausea, Immunoglobulin Light-chain Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IsatuximabBiological

    Also called Hu 38SB19, SAR 650984, SAR650984

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT03499808
Study groupRoleWhat they receive
Treatment (isatuximab)ExperimentalPatients receive isatuximab IV on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Isatuximab; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess Efficacy by Confirmed Overall Hematologic Response

    To assess the efficacy as measured by the confirmed overall hematologic response rate (partial response, very good partial response, complete response) of isatuximab in relapsed/ refractory systemic light chain (AL) amyloidosis. Measured as rate of partial response or better.

    Partial response is defined as a dFLC decrease of ≥ 50%, but remaining > 4.0 mg/dL.

    Very good partial response is defined as the difference between involved and uninvolved FLCs [dFLC] < 4.0 mg/dL.

    Complete response is defined as laboratory values within the normal range free light chain (FLC) ratio (0.25 - 1.65) and negative serum and urine immunofixation.

    Measured: From date of enrollment until progression or death due to any cause, whichever occurs first, assessed up to 4 years

Secondary outcomes (5)

  1. To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab.

    Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Measured: From date of enrollment until progression or death due to any cause, whichever occurs first, assessed up to 4 years

  2. Overall Survival (24 Month Estimate)

    Overall survival is measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. While OS was assessed up to 4 years, 4 year estimates were not reached. We are reporting the 24 month estimate (how many participants reached survival time of at least 24 months).

    Measured: From date of enrollment up to 2 years

  3. Duration of Response (24 Month Estimate)

    Duration of response is measure as time between hematologic response and hematologic progression.

    Hematologic progression is defined as 50% increase from nadir.

    While duration of response was assessed up to 4 years, 4 year estimates were not reached. We are reporting the 24 month estimate (how many participants achieved 24 month duration of response)

    Measured: Up to 2 years

  4. Time to Hematologic Response

    To evaluate time to hematologic response. Partial response is defined as a dFLC decrease of ≥ 50%, but remaining > 4.0 mg/dL.

    Very good partial response is defined as the difference between involved and uninvolved FLCs [dFLC] < 4.0 mg/dL.

    Complete response is defined as laboratory values within the normal range free light chain (FLC) ratio (0.25 - 1.65) and negative serum and urine immunofixation.

    Measured: From registration to time of confirmed hematologic progression

  5. Progression-free Survival (24 Month Estimate)

    To evaluate progression-free survival (24 month estimate)

    Hematologic progression is defined as 50% increase from nadir, or from baseline (if there was no response) in any ONE OR MORE of the following:

    1. Serum M-protein: 50% increase in Serum M protein to a value greater than 0.5 g/dL.
    2. Urine M protein: 50% increase in Urine M protein to a value greater than 200 mg/day (a visible peak must be present)
    3. Free light chain increase of 50% to a value greater than 10 mg/dL

    Measured: From registration to time of confirmed hematologic progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2018
  2. Study start6 Jun 2018
  3. Primary completion30 Aug 2023
  4. Study completion19 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03499808
Sponsor's protocol ID
S1702
Other IDs
NCI-2017-01375, S1702, S1702, U10CA180888
Status last verified
Feb 2025
First submitted
9 Apr 2018
Last updated
9 Sep 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Parker TL, Rosenthal A, Sanchorawala V, Landau HJ, Campagnaro EL, Kapoor P, Neparidze N, Girnius S, Hagen P, Scott EC, Hoering A, Durie BGM, Orlowski RZ. Isatuximab for relapsed and/or refractory AL amyloidosis: results of a prospective phase 2 trial (SWOG S1702). Blood. 2025 Nov 20;146(21):2507-2516. doi: 10.1182/blood.2024027962.

    PubMed 40925099

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