S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis



Status:Recruiting
Conditions:Constipation, Irritable Bowel Syndrome (IBS), Endocrine, Gastrointestinal, Gastrointestinal, Hematology, Hematology
Therapuetic Areas:Endocrinology, Gastroenterology, Hematology
Healthy:No
Age Range:18 - Any
Updated:9/2/2018
Start Date:March 8, 2018
End Date:July 31, 2025

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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.

PRIMARY OBJECTIVES:

I. 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:

I. 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:

I. 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.

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
We found this trial at
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Bremerton, Washington 98310
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100 E Idaho St
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Boston, Massachusetts 02118
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915 Highland Blvd
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Bryan, Texas 77802
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Burien, Washington 98166
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
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210 W Walnut St
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1600 South Canton Center Road
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211 Saint Francis Drive
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775 South Main Street
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14650 East Old US Highway 12
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Cincinnati, Ohio 45242
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Cincinnati, Ohio 45220
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Cincinnati, Ohio 45255
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Cincinnati, Ohio 45247
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
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Clackamas, Oregon 97015
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5680 Bow Pointe Drive
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31500 Telegraph Road
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Clinton, North Carolina 28328
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12495 University Ave
Clive, Iowa 50325
(515) 358-9700
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Clive, Iowa 50325
Principal Investigator: Mehmet S. Copur
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Cody, Wyoming 82414
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6001 E Woodmen Rd
Colorado Springs, Colorado 80923
(719) 776-5000
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Penrose-Saint Francis Healthcare Founded by the Sisters of St. Francis and the Sisters of Charity,...
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Colorado Springs, Colorado 80907
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
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Coos Bay, Oregon 97420
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Corbin, Kentucky 40701
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Council Bluffs, Iowa 51503
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Danville, Illinois 61832
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
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210 West McKinley Avenue
Decatur, Illinois 62526
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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Decatur, IL
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2525 S Downing St
Denver, Colorado 80210
(303) 778-1955
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
Porter Adventist Hospital Founded in 1930, Porter Adventist Hospital has provided people throughout Denver and...
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Denver, CO
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1111 6th Ave
Des Moines, Iowa 50314
(515) 247-3121
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
Mercy Medical Center - Des Moines Mercy Medical Center
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Des Moines, IA
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Des Moines, Iowa 50314
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Des Moines, IA
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
Principal Investigator: Jeffrey A. Zonder
Phone: 313-576-9790
Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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22101 Moross Rd
Detroit, Michigan 48236
(313) 343-4000
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
Saint John Hospital and Medical Center Founded in 1952, St. John Hospital and Medical Center...
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Detroit, MI
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Durango, Colorado 81301
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Durango, CO
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Durango, Colorado 81301
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Durango, CO
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17900 23 Mile Road
East China Township, Michigan 48054
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
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East China Township, MI
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East Stroudsburg, Pennsylvania 18301
Principal Investigator: Christopher M. Reynolds
Phone: 570-422-1700
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East Stroudsburg, PA
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6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
Principal Investigator: David M. King
Phone: 952-993-1517
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Edina, MN
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Edmonds, Washington 98026
Principal Investigator: Gary E. Goodman
Phone: 206-215-3086
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Edmonds, WA
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Effingham, Illinois 62401
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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Effingham, IL
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Effingham, Illinois 62401
Principal Investigator: Vamsi K. Vasireddy
Phone: 800-446-5532
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Effingham, IL
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1202 East Locust Street
Emmett, Idaho 83617
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
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Emmett, ID
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Enumclaw, Washington 98022
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Enumclaw, WA
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101 S Major St
Eureka, Illinois 61530
309-467-2371
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Eureka Illinois CancerCare is one of the largest private oncology and hematology...
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Eureka, IL
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1717 13th St
Everett, Washington 98201
(425) 297-5500
Principal Investigator: Gary E. Goodman
Phone: 425-261-3529
Providence Regional Cancer Partnership Founded in 2007, the Providence Regional Cancer Partnership is the result...
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Everett, WA
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Farmington Hills, Michigan 48334
Principal Investigator: Jeffrey A. Zonder
Phone: 313-576-9790
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Farmington Hills, MI
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Federal Way, Washington 98003
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Federal Way, WA
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Flint, Michigan 48503
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
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Flint, MI
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302 Kensington Ave
Flint, Michigan 48503
(810) 762-8490
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
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302 Kensington Avenue
Flint, Michigan 48503
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
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Flint, MI
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550 Osborne Rd NE
Fridley, Minnesota 55432
(763) 236-5000
Principal Investigator: David M. King
Phone: 952-993-1517
Unity Hospital Unity Hospital is one of the Twin Cities
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Fruitland, Idaho 83619
Principal Investigator: Gary E. Goodman
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