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Monoclonal Antibodies

Isatuximab for Amyloidosis

Phase 1
Recruiting
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
Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry (IHC) and polarizing light microscopy of green birefringent material in Congo red-stained tissue specimens in an organ other than bone marrow, characteristic electron microscopy appearance, or mass spectrometry. Specifically for male subjects 70 years of age or older who have cardiac involvement only and subjects of African descent, mass spectrometry typing of AL amyloid in a tissue biopsy is recommended to rule out other types of amyloidosis such as age-related amyloidosis or hereditary amyloidosis (ATTR mutation)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 19 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
My diagnosis of amyloidosis was confirmed through specific tests on my tissue samples.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-free proportion
Secondary outcome measures
Complete hematologic response proportion

Side effects data

From 2023 Phase 3 trial • 307 Patients • NCT02990338
35%
Neutropenia
21%
Fatigue
21%
Pneumonia
21%
Diarrhoea
20%
Constipation
19%
Upper Respiratory Tract Infection
19%
Asthenia
16%
Back Pain
13%
Pyrexia
12%
Oedema Peripheral
12%
Arthralgia
11%
Thrombocytopenia
11%
Bronchitis
11%
Muscle Spasms
9%
Dyspnoea
9%
Urinary Tract Infection
9%
Insomnia
9%
Nausea
9%
Bone Pain
7%
Nasopharyngitis
7%
Peripheral Sensory Neuropathy
7%
Cough
7%
Cataract
7%
Pruritus
6%
Headache
6%
Fall
5%
Disease Progression
5%
Hypertension
5%
Decreased Appetite
5%
Tremor
5%
Rash
5%
Muscular Weakness
5%
Musculoskeletal Chest Pain
4%
Influenza
4%
Abdominal Pain
4%
Acute Kidney Injury
4%
Vomiting
3%
Pneumocystis Jirovecii Pneumonia
3%
Febrile Neutropenia
3%
Oropharyngeal Pain
3%
Septic Shock
3%
Pathological Fracture
3%
Dizziness
3%
Stomatitis
3%
Myalgia
3%
Pain In Extremity
2%
Hypercalcaemia
2%
Oral Herpes
2%
Productive Cough
2%
General Physical Health Deterioration
2%
Renal Failure
2%
Lung Infection
2%
Lower Respiratory Tract Infection
1%
Haemorrhage Intracranial
1%
Syncope
1%
Cardiac Failure
1%
Atrial Fibrillation
1%
Cerebral Haemorrhage
1%
Cauda Equina Syndrome
1%
Diverticulitis
1%
Escherichia Sepsis
1%
Gastroenteritis
1%
Respiratory Tract Infection
1%
Anaemia
1%
Dehydration
1%
Ischaemic Stroke
1%
Orthostatic Hypotension
1%
Pleural Effusion
1%
Pulmonary Embolism
1%
Pulmonary Oedema
1%
Respiratory Failure
1%
Pancreatitis Acute
1%
Death
1%
Accidental Overdose
1%
Diabetic Ulcer
1%
Pneumonia Bacterial
1%
Pneumonia Fungal
1%
Pyelonephritis
1%
Pyelonephritis Acute
1%
Sepsis
1%
Sinusitis
1%
Hyperviscosity Syndrome
1%
Pancytopenia
1%
Malnutrition
1%
Sudden Death
1%
Femur Fracture
1%
Infusion Related Reaction
1%
Spinal Compression Fracture
1%
Cytomegalovirus Gastrointestinal Infection
1%
Pneumonia Haemophilus
1%
Pneumonia Influenzal
1%
Pneumonia Streptococcal
1%
Basal Cell Carcinoma
1%
Tumour Associated Fever
1%
Hyponatraemia
1%
Confusional State
1%
Bronchospasm
1%
Large Intestine Perforation
1%
Renal Aneurysm
1%
Weight Decreased
1%
Covid-19
1%
Covid-19 Pneumonia
1%
Candida Pneumonia
1%
Infection
1%
Presyncope
1%
Spinal Subdural Haematoma
1%
Retinal Detachment
1%
Vision Blurred
1%
Angina Pectoris
1%
Myocardial Infarction
1%
Deep Vein Thrombosis
1%
Ataxia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pd (Pomalidomide + Dexamethasone)
IPd (Isatuximab + Pomalidomide + Dexamethasone)

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
~2590
Bortezomib
2005
Completed Phase 2
~1140
Cyclophosphamide
1995
Completed Phase 3
~3780
Isatuximab
2016
Completed Phase 3
~370

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,632 Previous Clinical Trials
2,556,452 Total Patients Enrolled
SanofiIndustry Sponsor
2,160 Previous Clinical Trials
3,514,437 Total Patients Enrolled
1 Trials studying AL Amyloidosis
46 Patients Enrolled for AL Amyloidosis
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,370 Total Patients Enrolled
2 Trials studying AL Amyloidosis
362 Patients Enrolled for AL Amyloidosis

Media Library

Isatuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04754945 — Phase 1
AL Amyloidosis Research Study Groups: Treatment (isatuximab, chemotherapy)
AL Amyloidosis Clinical Trial 2023: Isatuximab Highlights & Side Effects. Trial Name: NCT04754945 — Phase 1
Isatuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04754945 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other experimental studies involving Isatuximab?

"Currently, 1322 live clinical studies into Isatuximab exist with 270 of them in their final phase. To further illustrate the scope of these trials, there are 42902 sites offering access to this medication - many of which being located in Philadelphia, Pennsylvania."

Answered by AI

How many participants is the research team seeking to include in this experiment?

"To be able to launch this trial, 25 participants need to meet the criteria. These individuals can sign up from either Columbia University in New york City or Emory University Hospital Midtown in Texas."

Answered by AI

Is Isatuximab generally tolerated by patients without major side effects?

"The safety of Isatuximab is believed to be relatively low, as this Phase 1 trial only has limited evidence backing its efficacy and security. Thus, our team at Power assigned it a score of 1."

Answered by AI

In what geographic areas is this medical research being conducted?

"This trial is running out of Columbia University in the city of New york, Emory University Hospital Midtown located in Dallas and UT Southwestern situated in Orange along with 6 additional sites."

Answered by AI

Is this research initiative still accepting participants?

"Affirmative. A review of the clinical trials website reveals that this research project, first posted on April 28th 2021 is currently recruiting participants. 25 individuals are required from 6 separate medical facilities."

Answered by AI

What conditions usually warrant the administration of Isatuximab?

"Isatuximab is typically used to alleviate synovitis, however it can be prescribed as a form of treatment for ophthalmia, sympathetic diseases, and certain forms of lung cancer or branch retinal vein occlusion."

Answered by AI
~8 spots leftby Sep 2025