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Monoclonal Antibodies

Isatuximab for Amyloidosis

Phase 1

Waitlist Available

Led By Craig C Hofmeister, MD, MPH

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have evidence of high risk AL amyloidosis defined as one of the following any time within the 6 months prior to consent: Biomarker-based indicators of severe disease: NT-proBNP > 8500 ng/L OR hs-cTnT >= 50 ng/L, BUMC 2019 stage 3b requiring both TnI > 0.1 ng/mL and BNP > 700 pg/mL, Mayo 2012 stage 4 that includes each of the following a) cTnT >= 0.025 ng/mL or hs-cTnT >= 40 ng/mL; b) NT-proBNP >= 1800 pg/mL; and c) dFLC >= 180 mg/L, Significant AL amyloid related hypotension (systolic blood pressure [SBP] < 100 mm Hg or symptomatic orthostatic hypotension defined as a decrease in systolic blood pressure upon standing of > 20 mm Hg despite medical management [fludrocortisone, midodrine, etc] in the absence of volume depletion), Absolute neutrophil count (ANC) >= 1000/uL, Platelet count >= 50,000 and platelet transfusion independent for 1 week prior to screening, Estimated creatinine clearance >= 20 mL/min/1.73 m^2 as defined by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI), Total bilirubin < 1.5 x institutional upper limit of normal (IULN) except for patients with Gilbert syndrome in which case total bilirubin =< 2 x IULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x IULN, Left ventricular ejection fraction >= 30%, Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting study medication. The effects of protocol therapy on the developing human fetus are unknown. For this reason, FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months after completion of protocol therapy. Men must refrain from donating sperm during the same period that they must agree to use contraception. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months, Ability to understand and the willingness to sign a written informed consent document, Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 19 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effects of isatuximab on patients with high-risk AL amyloidosis. Isatuximab is an antibody that may stop tumor cells from growing and spreading.

Who is the study for?

This trial is for adults with high risk AL amyloidosis, a condition where abnormal proteins build up in organs. Participants must have specific biomarkers indicating severe disease, adequate organ function, and no prior significant treatments for AL amyloidosis. They should not be HIV positive or have hepatitis B/C unless certain conditions are met. Women of childbearing potential must test negative for pregnancy and agree to use contraception.

What is being tested?

The trial tests the safety and effectiveness of isatuximab as an initial treatment option for high risk AL amyloidosis patients. Isatuximab is a monoclonal antibody designed to disrupt tumor cell growth. It's given alongside standard drugs like dexamethasone, bortezomib, and cyclophosphamide to see if it improves outcomes.

What are the potential side effects?

Potential side effects include reactions related to the immune system attacking normal cells (infusion reactions), low blood counts leading to increased infection risks or bleeding problems, fatigue, nausea, and possible harm to unborn babies; hence contraception is required during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 19 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 19 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 19 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-free proportion

Secondary study objectives

Complete hematologic response proportion

Side effects data

From 2023 Phase 3 trial • 307 Patients • NCT02990338

35%

Neutropenia

21%

Diarrhoea

21%

Fatigue

21%

Pneumonia

20%

Constipation

19%

Asthenia

19%

Upper Respiratory Tract Infection

16%

Back Pain

13%

Pyrexia

12%

Arthralgia

12%

Oedema Peripheral

11%

Bronchitis

11%

Thrombocytopenia

11%

Muscle Spasms

Dyspnoea

Insomnia

Nausea

Urinary Tract Infection

Bone Pain

Cough

Nasopharyngitis

Peripheral Sensory Neuropathy

Cataract

Pruritus

Fall

Headache

Hypertension

Disease Progression

Decreased Appetite

Tremor

Muscular Weakness

Musculoskeletal Chest Pain

Rash

Acute Kidney Injury

Influenza

Abdominal Pain

Vomiting

Pneumocystis Jirovecii Pneumonia

Febrile Neutropenia

Pathological Fracture

Oropharyngeal Pain

Myalgia

Pain In Extremity

Septic Shock

Dizziness

Stomatitis

Renal Failure

Lower Respiratory Tract Infection

Hypercalcaemia

General Physical Health Deterioration

Oral Herpes

Productive Cough

Lung Infection

Pleural Effusion

Haemorrhage Intracranial

Infusion Related Reaction

Pulmonary Embolism

Renal Aneurysm

Sudden Death

Pneumonia Fungal

Covid-19 Pneumonia

Candida Pneumonia

Diverticulitis

Escherichia Sepsis

Cytomegalovirus Gastrointestinal Infection

Gastroenteritis

Tumour Associated Fever

Syncope

Dehydration

Respiratory Tract Infection

Basal Cell Carcinoma

Anaemia

Hyponatraemia

Confusional State

Malnutrition

Cerebral Haemorrhage

Angina Pectoris

Cauda Equina Syndrome

Ischaemic Stroke

Atrial Fibrillation

Cardiac Failure

Orthostatic Hypotension

Pulmonary Oedema

Respiratory Failure

Pancreatitis Acute

Diabetic Ulcer

Death

Accidental Overdose

Spinal Compression Fracture

Weight Decreased

Pneumonia Bacterial

Pyelonephritis

Pyelonephritis Acute

Sepsis

Sinusitis

Hyperviscosity Syndrome

Pancytopenia

Femur Fracture

Pneumonia Haemophilus

Pneumonia Influenzal

Pneumonia Streptococcal

Bronchospasm

Large Intestine Perforation

Covid-19

Infection

Presyncope

Spinal Subdural Haematoma

Retinal Detachment

Vision Blurred

Myocardial Infarction

Deep Vein Thrombosis

Ataxia

100%

80%

60%

40%

20%

Study treatment Arm

Pd (Pomalidomide + Dexamethasone)

IPd (Isatuximab + Pomalidomide + Dexamethasone)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (isatuximab, chemotherapy)Experimental Treatment4 Interventions

All patients will receive Isatuximab plus dexamethasone 4 mg PO/IV days weekly. Based on tolerance, patients will add to their treatment subcutaneous Velcade (earliest time to add Velcade is cycle 1 day 15) and intravenous cyclophosphamide (earliest time to add cyclophosphamide is cycle 4 day 1) Patients then receive dexamethasone and isatuximab as maintenance treatment twice per month for 12 months in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Isatuximab

2016

Completed Phase 3

~370