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S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis

Sponsor
Southwest Oncology Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03499808
Collaborator
National Cancer Institute (NCI) (NIH)
43
Enrollment
345
Locations
1
Arm
88.8
Anticipated Duration (Months)
0.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Isatuximab
  • Other: Laboratory Biomarker Analysis
 Phase 2

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.

  2. 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.

  2. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Isatuximab (SAR650984) (NSC-795145) for Patients With Previously Treated AL Amyloidosis
Actual Study Start Date :
Mar 8, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (isatuximab)

Patients 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.

Biological: Isatuximab
Given IV
Other Names:
  • Hu 38SB19
  • SAR 650984
  • SAR650984

    • Other: Laboratory Biomarker Analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. Overall confirmed hematologic response rate [Up to 4 years]

      Will include partial response, very good partial response and complete response. Hematologic response will be reported with a binomial confidence interval.

    Secondary Outcome Measures

    1. Incidence of adverse events [Up to 4 years]

      Will be evaluated using the Common Terminology Criteria for Adverse Events version 4.0. The maximum grade for each toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.

    2. Organ response [Up to 4 years]

      Organ response will be evaluated in the subset of patients with evaluable organ involvement using current criteria. The proportion of patients with organ response will be estimated as the number of patients with documented organ response out of the number of patients with documented evaluable organ involvement at baseline.

    3. Overall survival [From date of registration to date of death due to any cause, assessed up to 4 years]

      Will be estimated using the Kaplan-Meier method.

    4. Progression free survival [From date of registration to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 4 years]

      Will be estimated using the Kaplan-Meier method.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anchorage Associates in Radiation Medicine Anchorage Alaska United States 98508
    2 Anchorage Radiation Therapy Center Anchorage Alaska United States 99504
    3 Alaska Breast Care and Surgery LLC Anchorage Alaska United States 99508
    4 Alaska Oncology and Hematology LLC Anchorage Alaska United States 99508
    5 Alaska Women's Cancer Care Anchorage Alaska United States 99508
    6 Anchorage Oncology Centre Anchorage Alaska United States 99508
    7 Katmai Oncology Group Anchorage Alaska United States 99508
    8 Providence Alaska Medical Center Anchorage Alaska United States 99508
    9 CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas United States 71913
    10 Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California United States 91505
    11 Fremont - Rideout Cancer Center Marysville California United States 95901
    12 UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California United States 92868
    13 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    14 Rocky Mountain Cancer Centers-Aurora Aurora Colorado United States 80012
    15 The Medical Center of Aurora Aurora Colorado United States 80012
    16 University of Colorado Hospital Aurora Colorado United States 80045
    17 Boulder Community Hospital Boulder Colorado United States 80301
    18 Rocky Mountain Cancer Centers-Boulder Boulder Colorado United States 80304
    19 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
    20 Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado United States 80907
    21 Denver Health Medical Center Denver Colorado United States 80204
    22 National Jewish Health-Main Campus Denver Colorado United States 80206
    23 The Women's Imaging Center Denver Colorado United States 80209
    24 Porter Adventist Hospital Denver Colorado United States 80210
    25 Colorado Blood Cancer Institute Denver Colorado United States 80218
    26 Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado United States 80218
    27 Rocky Mountain Cancer Centers-Midtown Denver Colorado United States 80218
    28 SCL Health Saint Joseph Hospital Denver Colorado United States 80218
    29 Rocky Mountain Cancer Centers-Rose Denver Colorado United States 80220
    30 Rose Medical Center Denver Colorado United States 80220
    31 Western Surgical Care Denver Colorado United States 80220
    32 Mercy Medical Center Durango Colorado United States 81301
    33 Southwest Oncology PC Durango Colorado United States 81301
    34 Comprehensive Cancer Care and Research Institute of Colorado LLC Englewood Colorado United States 80113
    35 Swedish Medical Center Englewood Colorado United States 80113
    36 Poudre Valley Hospital Fort Collins Colorado United States 80524
    37 Mountain Blue Cancer Care Center Golden Colorado United States 80401
    38 National Jewish Health-Western Hematology Oncology Golden Colorado United States 80401
    39 Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado United States 81501
    40 North Colorado Medical Center Greeley Colorado United States 80631
    41 Good Samaritan Medical Center Lafayette Colorado United States 80026
    42 Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado United States 80228
    43 Saint Anthony Hospital Lakewood Colorado United States 80228
    44 Rocky Mountain Cancer Centers-Littleton Littleton Colorado United States 80120
    45 Littleton Adventist Hospital Littleton Colorado United States 80122
    46 Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado United States 80124
    47 Sky Ridge Medical Center Lone Tree Colorado United States 80124
    48 Longmont United Hospital Longmont Colorado United States 80501
    49 Rocky Mountain Cancer Centers-Longmont Longmont Colorado United States 80501
    50 McKee Medical Center Loveland Colorado United States 80539
    51 Parker Adventist Hospital Parker Colorado United States 80138
    52 Rocky Mountain Cancer Centers-Parker Parker Colorado United States 80138
    53 Saint Mary Corwin Medical Center Pueblo Colorado United States 81004
    54 Rocky Mountain Cancer Centers - Pueblo Pueblo Colorado United States 81008
    55 National Jewish Health-Northern Hematology Oncology Thornton Colorado United States 80260
    56 Rocky Mountain Cancer Centers-Thornton Thornton Colorado United States 80260
    57 SCL Health Lutheran Medical Center Wheat Ridge Colorado United States 80033
    58 Smilow Cancer Hospital-Derby Care Center Derby Connecticut United States 06418
    59 Smilow Cancer Hospital Care Center-Fairfield Fairfield Connecticut United States 06824
    60 Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut United States 06105
    61 Smilow Cancer Center/Yale-New Haven Hospital New Haven Connecticut United States 06510
    62 Yale University New Haven Connecticut United States 06520
    63 Yale-New Haven Hospital North Haven Medical Center North Haven Connecticut United States 06473
    64 Smilow Cancer Hospital-Orange Care Center Orange Connecticut United States 06477
    65 Smilow Cancer Hospital-Torrington Care Center Torrington Connecticut United States 06790
    66 Smilow Cancer Hospital Care Center-Trumbull Trumbull Connecticut United States 06611
    67 Smilow Cancer Hospital-Waterbury Care Center Waterbury Connecticut United States 06708
    68 Mayo Clinic in Florida Jacksonville Florida United States 32224-9980
    69 Cleveland Clinic-Weston Weston Florida United States 33331
    70 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
    71 Saint Luke's Mountain States Tumor Institute Boise Idaho United States 83712
    72 Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho United States 83605
    73 Kootenai Medical Center Coeur d'Alene Idaho United States 83814
    74 Walter Knox Memorial Hospital Emmett Idaho United States 83617
    75 Saint Luke's Mountain States Tumor Institute - Fruitland Fruitland Idaho United States 83619
    76 Idaho Urologic Institute-Meridian Meridian Idaho United States 83642
    77 Saint Luke's Mountain States Tumor Institute - Meridian Meridian Idaho United States 83642
    78 Saint Alphonsus Medical Center-Nampa Nampa Idaho United States 83686
    79 Saint Luke's Mountain States Tumor Institute - Nampa Nampa Idaho United States 83686
    80 Kootenai Cancer Center Post Falls Idaho United States 83854
    81 Kootenai Cancer Clinic Sandpoint Idaho United States 83864
    82 Saint Luke's Mountain States Tumor Institute-Twin Falls Twin Falls Idaho United States 83301
    83 Rush - Copley Medical Center Aurora Illinois United States 60504
    84 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    85 Illinois CancerCare-Canton Canton Illinois United States 61520
    86 Memorial Hospital of Carbondale Carbondale Illinois United States 62902
    87 SIH Cancer Institute Carterville Illinois United States 62918
    88 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    89 Centralia Oncology Clinic Centralia Illinois United States 62801
    90 Carle on Vermilion Danville Illinois United States 61832
    91 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
    92 Decatur Memorial Hospital Decatur Illinois United States 62526
    93 Carle Physician Group-Effingham Effingham Illinois United States 62401
    94 Crossroads Cancer Center Effingham Illinois United States 62401
    95 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    96 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    97 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
    98 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    99 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    100 Carle Physician Group-Mattoon/Charleston Mattoon Illinois United States 61938
    101 Loyola University Medical Center Maywood Illinois United States 60153
    102 Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park Illinois United States 60160
    103 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    104 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    105 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    106 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    107 Illinois CancerCare-Peru Peru Illinois United States 61354
    108 Valley Radiation Oncology Peru Illinois United States 61354
    109 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    110 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    111 Springfield Clinic Springfield Illinois United States 62702
    112 Memorial Medical Center Springfield Illinois United States 62781
    113 Cancer Care Specialists of Illinois-Swansea Swansea Illinois United States 62226
    114 Southwest Illinois Health Services LLP Swansea Illinois United States 62226
    115 Carle Cancer Center Urbana Illinois United States 61801
    116 The Carle Foundation Hospital Urbana Illinois United States 61801
    117 Rush-Copley Healthcare Center Yorkville Illinois United States 60560
    118 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    119 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
    120 Alegent Health Mercy Hospital Council Bluffs Iowa United States 51503
    121 Greater Regional Medical Center Creston Iowa United States 50801
    122 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    123 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    124 Mercy Medical Center-West Lakes West Des Moines Iowa United States 50266
    125 Central Care Cancer Center - Garden City Garden City Kansas United States 67846
    126 Central Care Cancer Center - Great Bend Great Bend Kansas United States 67530
    127 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    128 Kansas Institute of Medicine Cancer and Blood Center Lenexa Kansas United States 66219
    129 Minimally Invasive Surgery Hospital Lenexa Kansas United States 66219
    130 Menorah Medical Center Overland Park Kansas United States 66209
    131 Saint Luke's South Hospital Overland Park Kansas United States 66213
    132 Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas United States 67208
    133 Cancer Center of Kansas - Wichita Wichita Kansas United States 67214
    134 Flaget Memorial Hospital Bardstown Kentucky United States 40004
    135 Commonwealth Cancer Center-Corbin Corbin Kentucky United States 40701
    136 Saint Joseph Radiation Oncology Resource Center Lexington Kentucky United States 40504
    137 Saint Joseph Hospital East Lexington Kentucky United States 40509
    138 Saint Joseph London London Kentucky United States 40741
    139 Jewish Hospital Louisville Kentucky United States 40202
    140 Saints Mary and Elizabeth Hospital Louisville Kentucky United States 40215
    141 Jewish Hospital Medical Center Northeast Louisville Kentucky United States 40245
    142 Jewish Hospital Medical Center South Shepherdsville Kentucky United States 40165
    143 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    144 Harold Alfond Center for Cancer Care Augusta Maine United States 04330
    145 Eastern Maine Medical Center Bangor Maine United States 04401
    146 Waldo County General Hospital Belfast Maine United States 04915
    147 MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford Maine United States 04005
    148 Lafayette Family Cancer Center-EMMC Brewer Maine United States 04412
    149 Stephens Memorial Hospital Norway Maine United States 04268
    150 MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford Maine United States 04073
    151 Boston Medical Center Boston Massachusetts United States 02118
    152 Mercy Medical Center Springfield Massachusetts United States 01104
    153 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    154 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    155 IHA Hematology Oncology Consultants-Brighton Brighton Michigan United States 48114
    156 Saint Joseph Mercy Brighton Brighton Michigan United States 48114
    157 IHA Hematology Oncology Consultants-Canton Canton Michigan United States 48188
    158 Saint Joseph Mercy Canton Canton Michigan United States 48188
    159 Caro Cancer Center Caro Michigan United States 48723
    160 IHA Hematology Oncology Consultants-Chelsea Chelsea Michigan United States 48118
    161 Saint Joseph Mercy Chelsea Chelsea Michigan United States 48118
    162 Hematology Oncology Consultants-Clarkston Clarkston Michigan United States 48346
    163 Newland Medical Associates-Clarkston Clarkston Michigan United States 48346
    164 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
    165 Ascension Saint John Hospital Detroit Michigan United States 48236
    166 Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan United States 48054
    167 Weisberg Cancer Treatment Center Farmington Hills Michigan United States 48334
    168 Genesee Cancer and Blood Disease Treatment Center Flint Michigan United States 48503
    169 Genesee Hematology Oncology PC Flint Michigan United States 48503
    170 Genesys Hurley Cancer Institute Flint Michigan United States 48503
    171 Hurley Medical Center Flint Michigan United States 48503
    172 Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan United States 48236
    173 Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan United States 48236
    174 Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan United States 48236
    175 Sparrow Hospital Lansing Michigan United States 48912
    176 Hope Cancer Clinic Livonia Michigan United States 48154
    177 Saint Mary Mercy Hospital Livonia Michigan United States 48154
    178 Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan United States 48044
    179 Michigan Breast Specialists-Macomb Township Macomb Michigan United States 48044
    180 Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan United States 48453
    181 21st Century Oncology-Pontiac Pontiac Michigan United States 48341
    182 Hope Cancer Center Pontiac Michigan United States 48341
    183 Newland Medical Associates-Pontiac Pontiac Michigan United States 48341
    184 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341
    185 Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan United States 48309
    186 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
    187 Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan United States 48604
    188 Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan United States 48312
    189 Ascension Saint Joseph Hospital Tawas City Michigan United States 48764
    190 Advanced Breast Care Center PLLC Warren Michigan United States 48088
    191 Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan United States 48093
    192 Macomb Hematology Oncology PC Warren Michigan United States 48093
    193 Michigan Breast Specialists-Warren Warren Michigan United States 48093
    194 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
    195 Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan United States 48661
    196 Huron Gastroenterology PC Ypsilanti Michigan United States 48106
    197 IHA Hematology Oncology Consultants-Ann Arbor Ypsilanti Michigan United States 48197
    198 Fairview Ridges Hospital Burnsville Minnesota United States 55337
    199 Cambridge Medical Center Cambridge Minnesota United States 55008
    200 Mercy Hospital Coon Rapids Minnesota United States 55433
    201 Fairview-Southdale Hospital Edina Minnesota United States 55435
    202 Unity Hospital Fridley Minnesota United States 55432
    203 Fairview Maple Grove Medical Center Maple Grove Minnesota United States 55369
    204 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
    205 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
    206 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    207 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    208 Health Partners Inc Minneapolis Minnesota United States 55454
    209 Monticello Cancer Center Monticello Minnesota United States 55362
    210 New Ulm Medical Center New Ulm Minnesota United States 56073
    211 Fairview Northland Medical Center Princeton Minnesota United States 55371
    212 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    213 Mayo Clinic Rochester Minnesota United States 55905
    214 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    215 Regions Hospital Saint Paul Minnesota United States 55101
    216 United Hospital Saint Paul Minnesota United States 55102
    217 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
    218 Lakeview Hospital Stillwater Minnesota United States 55082
    219 Ridgeview Medical Center Waconia Minnesota United States 55387
    220 Rice Memorial Hospital Willmar Minnesota United States 56201
    221 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    222 Fairview Lakes Medical Center Wyoming Minnesota United States 55092
    223 Central Care Cancer Center - Bolivar Bolivar Missouri United States 65613
    224 Parkland Health Center-Bonne Terre Bonne Terre Missouri United States 63628
    225 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    226 Southeast Cancer Center Cape Girardeau Missouri United States 63703
    227 Centerpoint Medical Center LLC Independence Missouri United States 64057
    228 Capital Region Southwest Campus Jefferson City Missouri United States 65109
    229 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
    230 Research Medical Center Kansas City Missouri United States 64132
    231 Saint Luke's East - Lee's Summit Lee's Summit Missouri United States 64086
    232 Heartland Regional Medical Center Saint Joseph Missouri United States 64507
    233 Washington University School of Medicine Saint Louis Missouri United States 63110
    234 Siteman Cancer Center-South County Saint Louis Missouri United States 63129
    235 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    236 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
    237 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
    238 Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri United States 63127
    239 Community Hospital of Anaconda Anaconda Montana United States 59711
    240 Billings Clinic Cancer Center Billings Montana United States 59101
    241 Saint Vincent Healthcare Billings Montana United States 59101
    242 Saint Vincent Frontier Cancer Center Billings Montana United States 59102
    243 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    244 Saint James Community Hospital and Cancer Treatment Center Butte Montana United States 59701
    245 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    246 Great Falls Clinic Great Falls Montana United States 59405
    247 Saint Peter's Community Hospital Helena Montana United States 59601
    248 Kalispell Regional Medical Center Kalispell Montana United States 59901
    249 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
    250 Community Medical Hospital Missoula Montana United States 59804
    251 CHI Health Saint Francis Grand Island Nebraska United States 68803
    252 Heartland Hematology and Oncology Kearney Nebraska United States 68845
    253 CHI Health Good Samaritan Kearney Nebraska United States 68847
    254 Saint Elizabeth Regional Medical Center Lincoln Nebraska United States 68510
    255 Alegent Health Immanuel Medical Center Omaha Nebraska United States 68122
    256 Hematology and Oncology Consultants PC Omaha Nebraska United States 68122
    257 Alegent Health Bergan Mercy Medical Center Omaha Nebraska United States 68124
    258 Alegent Health Lakeside Hospital Omaha Nebraska United States 68130
    259 Creighton University Medical Center Omaha Nebraska United States 68131
    260 Midlands Community Hospital Papillion Nebraska United States 68046
    261 Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey United States 07920
    262 Memorial Sloan Kettering Monmouth Middletown New Jersey United States 07748
    263 Memorial Sloan Kettering Commack Commack New York United States 11725
    264 Memorial Sloan Kettering Westchester Harrison New York United States 10604
    265 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    266 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    267 University of Rochester Rochester New York United States 14642
    268 Memorial Sloan Kettering Nassau Uniondale New York United States 11553
    269 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    270 Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina United States 28203
    271 Southeastern Medical Oncology Center-Clinton Clinton North Carolina United States 28328
    272 Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina United States 27534
    273 Wayne Memorial Hospital Goldsboro North Carolina United States 27534
    274 East Carolina University Greenville North Carolina United States 27834
    275 Onslow Memorial Hospital Jacksonville North Carolina United States 28546
    276 Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina United States 28546
    277 Good Samaritan Hospital - Cincinnati Cincinnati Ohio United States 45220
    278 Bethesda North Hospital Cincinnati Ohio United States 45242
    279 TriHealth Cancer Institute-Westside Cincinnati Ohio United States 45247
    280 TriHealth Cancer Institute-Anderson Cincinnati Ohio United States 45255
    281 Case Western Reserve University Cleveland Ohio United States 44106
    282 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    283 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    284 Saint Alphonsus Medical Center-Baker City Baker City Oregon United States 97814
    285 Saint Charles Health System Bend Oregon United States 97701
    286 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
    287 Providence Oncology and Hematology Care Southeast Clackamas Oregon United States 97015
    288 Bay Area Hospital Coos Bay Oregon United States 97420
    289 Providence Newberg Medical Center Newberg Oregon United States 97132
    290 Saint Alphonsus Medical Center-Ontario Ontario Oregon United States 97914
    291 Providence Portland Medical Center Portland Oregon United States 97213
    292 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    293 Kaiser Permanente Northwest Portland Oregon United States 97227
    294 Oregon Health and Science University Portland Oregon United States 97239
    295 Saint Charles Health System-Redmond Redmond Oregon United States 97756
    296 Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania United States 18103
    297 Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania United States 18017
    298 Pocono Medical Center East Stroudsburg Pennsylvania United States 18301
    299 Lehigh Valley Hospital-Hazleton Hazleton Pennsylvania United States 18201
    300 Memorial Hospital Chattanooga Tennessee United States 37404
    301 Pulmonary Medicine Center of Chattanooga-Hixson Hixson Tennessee United States 37343
    302 Memorial GYN Plus Ooltewah Tennessee United States 37363
    303 Saint Joseph Regional Cancer Center Bryan Texas United States 77802
    304 Providence Regional Cancer System-Aberdeen Aberdeen Washington United States 98520
    305 PeaceHealth Saint Joseph Medical Center Bellingham Washington United States 98225
    306 Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington United States 98310
    307 Harrison Medical Center Bremerton Washington United States 98310
    308 Highline Medical Center-Main Campus Burien Washington United States 98166
    309 Providence Regional Cancer System-Centralia Centralia Washington United States 98531
    310 Swedish Cancer Institute-Edmonds Edmonds Washington United States 98026
    311 Saint Elizabeth Hospital Enumclaw Washington United States 98022
    312 Providence Regional Cancer Partnership Everett Washington United States 98201
    313 Saint Francis Hospital Federal Way Washington United States 98003
    314 Swedish Cancer Institute-Issaquah Issaquah Washington United States 98029
    315 Kadlec Clinic Hematology and Oncology Kennewick Washington United States 99336
    316 Providence Regional Cancer System-Lacey Lacey Washington United States 98503
    317 Saint Clare Hospital Lakewood Washington United States 98499
    318 PeaceHealth Saint John Medical Center Longview Washington United States 98632
    319 Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington United States 98370
    320 Pacific Gynecology Specialists Seattle Washington United States 98104
    321 Swedish Medical Center-Ballard Campus Seattle Washington United States 98107
    322 Kaiser Permanente Washington Seattle Washington United States 98112
    323 Swedish Medical Center-First Hill Seattle Washington United States 98122-4307
    324 Swedish Medical Center-Cherry Hill Seattle Washington United States 98122-5711
    325 PeaceHealth United General Medical Center Sedro-Woolley Washington United States 98284
    326 Providence Regional Cancer System-Shelton Shelton Washington United States 98584
    327 Franciscan Research Center-Northwest Medical Plaza Tacoma Washington United States 98405
    328 Northwest Medical Specialties PLLC Tacoma Washington United States 98405
    329 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
    330 Providence Saint Mary Regional Cancer Center Walla Walla Washington United States 99362
    331 Providence Regional Cancer System-Yelm Yelm Washington United States 98597
    332 United Hospital Center Bridgeport West Virginia United States 26330
    333 WVUH-Berkely Medical Center Martinsburg West Virginia United States 25401
    334 West Virginia University Healthcare Morgantown West Virginia United States 26506
    335 Camden Clark Medical Center Parkersburg West Virginia United States 26101
    336 Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin United States 54701
    337 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    338 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    339 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
    340 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    341 Marshfield Clinic Stevens Point Center Stevens Point Wisconsin United States 54482
    342 Marshfield Clinic - Weston Center Weston Wisconsin United States 54476
    343 Cheyenne Regional Medical Center-West Cheyenne Wyoming United States 82001
    344 Billings Clinic-Cody Cody Wyoming United States 82414
    345 Welch Cancer Center Sheridan Wyoming United States 82801

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Emma Scott, Southwest Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT03499808
    Other Study ID Numbers:
    • S1702
    • NCI-2017-01375
    • S1702
    • S1702
    • U10CA180888
    First Posted:
    Apr 17, 2018
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Immunoglobulin Light-chain Amyloidosis
    Gastrointestinal Hemorrhage
    Hepatomegaly
    Macroglossia
    Purpura
    Lymphadenopathy
    Amyloidosis
    Hemorrhage
    Constipation
    Diarrhea

    Study Results

    No Results Posted as of Aug 24, 2022