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Monoclonal Antibodies
Isatuximab for Smoldering Multiple Myeloma
Phase 2
Waitlist Available
Led By Elisabet E Manasanch
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must meet criteria for high risk of progression to multiple myeloma by PETHEMA criteria (patients must have at least 2 risk factors present)
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial looks at how well a monoclonal antibody called isatuximab works in treating patients with smoldering plasma cell myeloma that is high risk.
Who is the study for?
Adults over 18 with high risk smoldering plasma cell myeloma, showing specific levels of monoclonal protein or bone marrow plasma cells. They must be at high risk for developing multiple myeloma and have good kidney, liver, and blood health. Women who can bear children and men with partners who can must use birth control. Exclusions include HIV, recent major surgery, uncontrolled diseases like heart failure or hypertension, prior treatments for this condition, pregnancy or breastfeeding.Check my eligibility
What is being tested?
The trial is testing Isatuximab's effectiveness in patients with a pre-cancerous condition called high risk smoldering plasma cell myeloma. It's an immunotherapy that may help the immune system prevent tumor growth and spread. The study includes monitoring through lab biomarker analysis to see how well it works.See study design
What are the potential side effects?
While not explicitly listed here, side effects of Isatuximab could include infusion reactions (like fever or chills), low blood counts leading to increased infection risks or bleeding problems, fatigue, nausea and potential allergic reactions due to its nature as a monoclonal antibody.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at high risk of my condition progressing to multiple myeloma according to PETHEMA criteria.
Select...
I am 18 years old or older.
Select...
I am able to get out of my bed or chair and move around.
Select...
I have SMM with specific protein levels in my blood or urine, or a certain percentage of plasma cells in my bone marrow.
Select...
My liver tests are within normal limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response (>= partial response)
Secondary outcome measures
Incidence of adverse events
Overall survival
Progression free survival
Other outcome measures
Genetic polymorphisms
Immune characterization
Mechanisms of resistance to isatuximab
+2 moreSide effects data
From 2023 Phase 3 trial • 307 Patients • NCT0299033835%
Neutropenia
21%
Fatigue
21%
Diarrhoea
21%
Pneumonia
20%
Constipation
19%
Asthenia
19%
Upper Respiratory Tract Infection
16%
Back Pain
13%
Pyrexia
12%
Oedema Peripheral
12%
Arthralgia
11%
Bronchitis
11%
Thrombocytopenia
11%
Muscle Spasms
9%
Dyspnoea
9%
Nausea
9%
Insomnia
9%
Urinary Tract Infection
9%
Bone Pain
7%
Cough
7%
Cataract
7%
Nasopharyngitis
7%
Peripheral Sensory Neuropathy
7%
Pruritus
6%
Headache
6%
Fall
5%
Muscular Weakness
5%
Decreased Appetite
5%
Hypertension
5%
Tremor
5%
Musculoskeletal Chest Pain
5%
Disease Progression
5%
Rash
4%
Vomiting
4%
Acute Kidney Injury
4%
Influenza
4%
Abdominal Pain
3%
Myalgia
3%
Pathological Fracture
3%
Pain In Extremity
3%
Pneumocystis Jirovecii Pneumonia
3%
Febrile Neutropenia
3%
Oropharyngeal Pain
3%
Septic Shock
3%
Dizziness
3%
Stomatitis
2%
Lower Respiratory Tract Infection
2%
Renal Failure
2%
Hypercalcaemia
2%
Oral Herpes
2%
Productive Cough
2%
General Physical Health Deterioration
2%
Lung Infection
1%
Renal Aneurysm
1%
Diabetic Ulcer
1%
Spinal Compression Fracture
1%
Orthostatic Hypotension
1%
Malnutrition
1%
Respiratory Tract Infection
1%
Confusional State
1%
Cerebral Haemorrhage
1%
Haemorrhage Intracranial
1%
Atrial Fibrillation
1%
Tumour Associated Fever
1%
Hyponatraemia
1%
Cauda Equina Syndrome
1%
Angina Pectoris
1%
Cardiac Failure
1%
Covid-19 Pneumonia
1%
Syncope
1%
Pancreatitis Acute
1%
Sudden Death
1%
Cytomegalovirus Gastrointestinal Infection
1%
Infusion Related Reaction
1%
Candida Pneumonia
1%
Pneumonia Fungal
1%
Basal Cell Carcinoma
1%
Diverticulitis
1%
Escherichia Sepsis
1%
Gastroenteritis
1%
Anaemia
1%
Dehydration
1%
Ischaemic Stroke
1%
Pleural Effusion
1%
Pulmonary Embolism
1%
Pulmonary Oedema
1%
Respiratory Failure
1%
Death
1%
Accidental Overdose
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%
Weight Decreased
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)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (isatuximab)Experimental Treatment2 Interventions
Patients receive isatuximab IV over 5 hours on day 1 of cycle 1, and over 3 hours thereafter on days 8, 15, and 22 of cycle 1, on days 1 and 15 of cycles 2-6, and on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 30 cycles 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?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,741 Total Patients Enrolled
36 Trials studying Plasma Cell Myeloma
1,867 Patients Enrolled for Plasma Cell Myeloma
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,606 Total Patients Enrolled
65 Trials studying Plasma Cell Myeloma
8,047 Patients Enrolled for Plasma Cell Myeloma
Elisabet E ManasanchPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
650 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not undergone radiotherapy.Your blood calcium levels are too high.I do not have any uncontrolled illnesses like high blood pressure or heart problems.My kidney function is reduced with specific test results.I have not had major surgery in the last month.I am not allergic or unable to take any medication required before therapy.I do not have an uncontrolled lung condition.I have one or more bone lesions detectable by scans.I am at high risk of my condition progressing to multiple myeloma according to PETHEMA criteria.I am 18 years old or older.I am able to get out of my bed or chair and move around.I agree to use birth control to prevent pregnancy during the study.I have SMM with specific protein levels in my blood or urine, or a certain percentage of plasma cells in my bone marrow.You are allergic to certain ingredients in infused protein products.Your bone marrow contains a high percentage of abnormal plasma cells.I have not used chemotherapy or CD38 drugs for smoldering multiple myeloma.I agree not to donate sperm during and for 5 months after the study.Your test shows that the ratio of certain proteins in your blood is very high.If you are a woman who could become pregnant, you need to have a negative pregnancy test before starting the treatment and at the end of the treatment.I do not have an active hepatitis B or C infection.My liver tests are within normal limits.You have more than one specific spot on your MRI, and each spot is at least 5 millimeters in size.Your hemoglobin level is lower than 10 g/dL or higher than 2 g/dL than the normal range.I am taking medication for bone health.Your white blood cell count, red blood cell count, and platelet count are within a certain range.I have been diagnosed with plasma cell leukemia.I am not currently receiving any other cancer treatments.I am HIV positive.Your kidneys work well enough to clear at least 40 milliliters of creatinine from your body every minute.My tests show signs of myeloma or cancerous cell growth.I am not on corticosteroids, except for stable doses for respiratory diseases or hormone disorders.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do you know of any other research studies that have used Isatuximab?
"Isatuximab was first studied in 2010 at site 604001. 574 completed trials later, there are presently 46 active clinical studies being conducted - a significant number of which taking place in Houston, Texas."
Answered by AI
Is this a closed or open clinical trial?
"The latest information available on clinicaltrials.gov suggests that this trial is still recruiting patients. The listing was created on 2/8/2017 and updated for the 9/28/2022."
Answered by AI
What other similar trials have been conducted in the past?
"Since first being studied in 2010, Isatuximab has undergone 46 clinical trials across 358 cities and 39 countries."
Answered by AI
What is the official stance of the FDA on Isatuximab?
"Isatuximab's safety is tentatively rated as a 2. This score comes from it being a Phase 2 trial, where there some data supporting safety but not efficacy."
Answered by AI
How many people are allowed to join this research project?
"That is correct, the online clinicaltrials.gov registry currently lists this study as open and recruiting. The trial was first advertised on February 8th, 2017 and was most recently updated on September 28th, 2022. They are looking to enroll 61 individuals at 2 sites total."
Answered by AI
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