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Monoclonal Antibodies
Isatuximab for Primary Amyloidosis
Phase 2
Waitlist Available
Led By Emma Scott
Research Sponsored by Southwest Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
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
Must not have
History of any lymphoproliferative disorder
History of active malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying how well a monoclonal antibody called isatuximab works in treating patients with primary amyloidosis that has come back or does not respond to treatment.
Who is the study for?
This trial is for adults with primary amyloidosis that has returned or isn't responding to treatment. They must not have taken certain anti-amyloidogenic substances recently, should be in relatively good health with a performance status of <=2, and have no severe allergies to monoclonal antibodies like isatuximab. Participants need functioning major organs, controlled blood pressure and diabetes, no HIV/AIDS complications, and cannot be pregnant or breastfeeding.
What is being tested?
The trial tests the effectiveness of Isatuximab—a type of monoclonal antibody—in patients with relapsed or refractory primary amyloidosis. It aims to see if this drug can stop cancer cells from growing and spreading. The study also includes laboratory biomarker analysis to monitor responses.
What are the potential side effects?
Potential side effects may include allergic reactions due to the body's response to a foreign protein (isatuximab), as well as symptoms related to immune system activation such as fever, chills, weakness, nausea, headache, rash or breathing difficulties.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have heart issues not caused by high blood pressure or heart valve disease.
Select...
I finished my last cancer treatment or surgery more than 2 weeks ago, and any stem cell transplant over 100 days ago.
Select...
I haven't taken daratumumab in the last 56 days and it was effective when I did.
Select...
My cancer has spread to other organs, as confirmed by tests.
Select...
My condition did not improve after at least one treatment like transplant, radiation, or chemotherapy.
Select...
I have high levels of protein in my urine or a kidney biopsy showing amyloid deposits.
Select...
I am not eligible for a stem cell transplant using my own cells.
Select...
My heart failure is not the most severe type.
Select...
I do not have any serious health issues that are not under control.
Select...
I am willing to follow my HIV treatment plan closely.
Select...
My AL amyloidosis has returned or didn't respond to treatment, confirmed by specific tests.
Select...
I am not allergic to isatuximab or similar antibody treatments.
Select...
I can take care of myself but might not be able to do heavy physical work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a condition where my lymphocytes grow abnormally.
Select...
I have a history of cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall confirmed hematologic response rate
Secondary study objectives
Incidence of adverse events
Organ response
Overall survival
+1 moreSide effects data
From 2023 Phase 3 trial • 307 Patients • NCT0299033835%
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
9%
Dyspnoea
9%
Insomnia
9%
Nausea
9%
Urinary Tract Infection
9%
Bone Pain
7%
Cough
7%
Nasopharyngitis
7%
Peripheral Sensory Neuropathy
7%
Cataract
7%
Pruritus
6%
Fall
6%
Headache
5%
Hypertension
5%
Disease Progression
5%
Decreased Appetite
5%
Tremor
5%
Muscular Weakness
5%
Musculoskeletal Chest Pain
5%
Rash
4%
Acute Kidney Injury
4%
Influenza
4%
Abdominal Pain
4%
Vomiting
3%
Pneumocystis Jirovecii Pneumonia
3%
Febrile Neutropenia
3%
Pathological Fracture
3%
Oropharyngeal Pain
3%
Myalgia
3%
Pain In Extremity
3%
Septic Shock
3%
Dizziness
3%
Stomatitis
2%
Renal Failure
2%
Lower Respiratory Tract Infection
2%
Hypercalcaemia
2%
General Physical Health Deterioration
2%
Oral Herpes
2%
Productive Cough
2%
Lung Infection
1%
Pleural Effusion
1%
Haemorrhage Intracranial
1%
Infusion Related Reaction
1%
Pulmonary Embolism
1%
Renal Aneurysm
1%
Sudden Death
1%
Pneumonia Fungal
1%
Covid-19 Pneumonia
1%
Candida Pneumonia
1%
Diverticulitis
1%
Escherichia Sepsis
1%
Cytomegalovirus Gastrointestinal Infection
1%
Gastroenteritis
1%
Tumour Associated Fever
1%
Syncope
1%
Dehydration
1%
Respiratory Tract Infection
1%
Basal Cell Carcinoma
1%
Anaemia
1%
Hyponatraemia
1%
Confusional State
1%
Malnutrition
1%
Cerebral Haemorrhage
1%
Angina Pectoris
1%
Cauda Equina Syndrome
1%
Ischaemic Stroke
1%
Atrial Fibrillation
1%
Cardiac Failure
1%
Orthostatic Hypotension
1%
Pulmonary Oedema
1%
Respiratory Failure
1%
Pancreatitis Acute
1%
Diabetic Ulcer
1%
Death
1%
Accidental Overdose
1%
Spinal Compression Fracture
1%
Weight Decreased
1%
Pneumonia Bacterial
1%
Pyelonephritis
1%
Pyelonephritis Acute
1%
Sepsis
1%
Sinusitis
1%
Hyperviscosity Syndrome
1%
Pancytopenia
1%
Femur Fracture
1%
Pneumonia Haemophilus
1%
Pneumonia Influenzal
1%
Pneumonia Streptococcal
1%
Bronchospasm
1%
Large Intestine Perforation
1%
Covid-19
1%
Infection
1%
Presyncope
1%
Spinal Subdural Haematoma
1%
Retinal Detachment
1%
Vision Blurred
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)
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)Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isatuximab
2016
Completed Phase 3
~370
Find a Location
Who is running the clinical trial?
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,144 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
398 Previous Clinical Trials
266,559 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,924 Previous Clinical Trials
41,017,908 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's pumping ability, measured by echocardiogram, is at least 35%.Your doctor needs to confirm that you have a specific amount of disease and certain blood tests done before you can join the study.Your blood test results must show a significant difference between two types of proteins in your blood within 14 days before joining the study.I have hepatitis B with minimal liver damage and am on effective treatment, or I had hepatitis C, treated and cured, with minimal liver damage.I would be expected to live a normal lifespan if not for my relapsed/refractory amyloid condition.I have heart issues not caused by high blood pressure or heart valve disease.My cancer has spread to other organs, as confirmed by tests.I do not have active symptoms of multiple myeloma according to the IMWG criteria.My condition did not improve after at least one treatment like transplant, radiation, or chemotherapy.Your liver enzymes (SGOT/AST and SGPT/ALT) should not be more than 4 times the normal level in the 14 days before you join the study.I had a full medical check-up within the last 14 days.I have never had an AIDS-defining condition.I haven't had cancer in the last 5 years, except for skin cancer.I am not eligible for a stem cell transplant using my own cells.My recent tests show detailed bone marrow analysis results.My heart failure is not the most severe type.I do not have any serious health issues that are not under control.I haven't taken any supplements or drugs like doxycycline or curcumin in the last 14 days.My kidney function, measured by creatinine clearance, is adequate.My hemoglobin level is at least 8 g/dL, possibly after a recent transfusion.My blood pressure has been below 160/100 in the last 14 days.I have had a condition where my lymphocytes grow abnormally.I have a history of cancer.I finished my last cancer treatment or surgery more than 2 weeks ago, and any stem cell transplant over 100 days ago.I haven't taken daratumumab in the last 56 days and it was effective when I did.I have high levels of protein in my urine or a kidney biopsy showing amyloid deposits.I am not pregnant, can take a pregnancy test before each treatment, and will use birth control or abstain from sex.You have HIV, but if you meet all the other criteria, you can still participate in the study.My diabetes is under control with an HbA1C level below 7%.Your total bilirubin level needs to be less than 2 times the upper limit of normal within 14 days before joining the study.I am willing to follow my HIV treatment plan closely.My AL amyloidosis has returned or didn't respond to treatment, confirmed by specific tests.Your standard HIV test shows no sign of the virus in your blood.I am not allergic to isatuximab or similar antibody treatments.Your platelet count should be at least 75,000 cells per microliter within 14 days before joining the study.I can take care of myself but might not be able to do heavy physical work.Your NT-proBNP level needs to be less than or equal to 8500 ng/L within 14 days before you join the study.In the 14 days before signing up for the trial, your white blood cell count should be at least 1,000 cells/microliter without needing additional medication.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (isatuximab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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