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Proteasome Inhibitor
Quadruple Therapy for Multiple Myeloma
Phase 2
Recruiting
Led By Andrew J. Cowan
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years and older, and have the capacity to give informed consent
Must have received prior lenalidomide therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights
Study Summary
This trial is studying if a combination of isatuximab, carfilzomib, pomalidomide, and dexamethasone can shrink or slow the growth of multiple myeloma in patients who have relapsed or are refractory.
Who is the study for?
This trial is for adults with multiple myeloma that has returned or isn't responding to treatment. Participants must have had prior therapy including lenalidomide, measurable disease by specific criteria, and adequate organ function. They should not have uncontrolled infections, certain heart conditions, other primary malignancies not in remission for at least a year (with some exceptions), or recent anti-CD38 monoclonal antibody therapy.Check my eligibility
What is being tested?
The study examines the combination of isatuximab (a cancer cell growth inhibitor), carfilzomib (blocks proteins needed for cancer cell growth), pomalidomide (may shrink/slow tumor growth), and dexamethasone (an anti-inflammatory) in treating relapsed/refractory multiple myeloma. It's a phase II trial aiming to see if this drug combo can effectively kill more cancer cells.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system due to isatuximab, fatigue, blood disorders from carfilzomib and pomalidomide, increased risk of infection from all drugs involved, and possible steroid-related effects such as elevated blood sugar levels from dexamethasone.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 and can understand and agree to the study's details.
Select...
I have been treated with lenalidomide before.
Select...
My nerve damage does not severely affect my daily activities.
Select...
I have a tumor from plasma cells that is at least 2 cm big.
Select...
I have multiple myeloma that has returned or didn't respond to treatment, and I've had at least one prior therapy.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate
Secondary outcome measures
Incidence of adverse events
Overall survival
Progression-free survival (PFS)
+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%
Diabetic Ulcer
1%
Spinal Compression Fracture
1%
Orthostatic Hypotension
1%
Renal Aneurysm
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, carfilzomib, pomalidomide, steroid)Experimental Treatment4 Interventions
INDUCTION: Patients receive isatuximab IV on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of subsequent cycles carfilzomib IV over 30 minutes on days 1, 8, and 15, pomalidomide PO QD on days 1-21, and dexamethasone PO or IV on days 1,8, 15, and 22. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive isatuximab IV days 1 and 15, carfilzomib IV over 30 minutes on days 1 and 15, pomalidomide PO QD on days 1-21, and dexamethasone PO or IV on days 1, 8, 15, and 22. Cycles repeat every 28 days for up to 24 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
Carfilzomib
2017
Completed Phase 3
~1440
Isatuximab
2016
Completed Phase 3
~370
Pomalidomide
2011
Completed Phase 2
~1020
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,729 Total Patients Enrolled
8 Trials studying Multiple Myeloma
432 Patients Enrolled for Multiple Myeloma
Genzyme, a Sanofi CompanyIndustry Sponsor
524 Previous Clinical Trials
85,592 Total Patients Enrolled
27 Trials studying Multiple Myeloma
9,777 Patients Enrolled for Multiple Myeloma
Andrew J. CowanPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Multiple Myeloma
40 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a high amount of plasma cells in your bone marrow.Your kidney function, as measured by eGFR, needs to be at least 20 ml/min or higher.You are currently taking other cancer medications or experimental treatments.Your total bilirubin level is within the normal range.I have serious heart problems, including recent heart attack or heart failure.My side effects from previous treatments are mild or gone, except for possible nerve issues.Your ALT and AST levels are not more than three times the upper limit of normal.I am over 18 and can understand and agree to the study's details.You have enough infection-fighting white blood cells in your body.I have been treated with lenalidomide before.I had Hepatitis C but have been treated and cured, or I am currently being treated with an undetectable viral load.I haven't had anti-CD38 therapy in the last 3 months.I agree to use two forms of birth control or abstain from sex during and after the study.Your blood test shows high levels of free light chains and an abnormal ratio of certain proteins.I had a stem cell transplant more than 6 months ago.Your platelet count is at least 50,000 per microliter.Your high blood pressure is not well managed, as determined by the main doctor in charge of the study.My nerve damage does not severely affect my daily activities.You must have a detectable and measurable disease based on specific criteria set by the International Myeloma Working Group.Your hemoglobin level is at least 8 grams per deciliter.I can use medications or transfusions to meet the blood cell count requirements.You have a high level of M protein in your urine.I have a tumor from plasma cells that is at least 2 cm big.I have multiple myeloma that has returned or didn't respond to treatment, and I've had at least one prior therapy.I do not have an active, uncontrolled infection.Your blood test shows a high level of M protein (greater than or equal to 0.5 grams per deciliter).I have active plasma cell leukemia or AL amyloidosis.I can take care of myself and am up and about more than half of my waking hours.I have had cancer before, but it has been in remission for at least a year, except for certain types.My hepatitis B is under control with medication.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (isatuximab, carfilzomib, pomalidomide, steroid)
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.
What primary medical conditions is Isatuximab applied to?
"Isatuximab is the most common method of treating ophthalmia, sympathetic. This medication can also be beneficial for those suffering from branch retinal vein occlusion, macular edema, and communicable diseases."
Answered by AI
Are there any safety considerations associated with Isatuximab treatments?
"Limited evidence of isatuximab's safety has been documented, so we assigned it a rating of 2. There are no clinical studies that demonstrate the efficacy of this drug yet."
Answered by AI
How many participants are engaged in this experiment?
"Affirmative. Per the details on clinicaltrials.gov, this research endeavour was first posted on July 29th 2021 and is still actively searching for participants. The trial site needs to enroll 37 people in total."
Answered by AI
Are there any open opportunities to participate in this clinical experiment?
"Affirmative. According to information on clinicaltrials.gov, this medical trial is currently seeking participants and was first posted on July 29th 2021. The study requires 37 patients from one particular location and has been recently updated on August 16th 2022."
Answered by AI
Have any other trials been conducted to investigate the efficacy of Isatuximab?
"Presently, Isatuximab is the subject of 593 active studies. Of these trials, 146 are in Phase 3 and hosted mostly at a single location in Joliet, Illinois; however, 19405 other clinical trial sites around the world offer access this medication as well."
Answered by AI
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