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Proteasome Inhibitor
Quadruple Therapy for Multiple Myeloma
Phase 2
Waitlist Available
Led By Jacob C Laubach, MD
Research Sponsored by Jacob Laubach, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Previously diagnosed with MM based on standard IMWG criteria and currently requires treatment
- Calculated creatinine clearance ≥ 30 mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up induction to up to 3.5 years
Awards & highlights
Study Summary
This trial is testing a new drug for safety and effectiveness in treating multiple myeloma.
Who is the study for?
This trial is for people up to 75 years old with newly diagnosed multiple myeloma who need treatment and are eligible for stem cell transplant. They must have measurable disease, acceptable blood counts, organ function within certain limits, and agree to follow specific safety programs. Pregnant or breastfeeding women, those unwilling to use contraception, or anyone treated for another cancer in the last 3 years cannot join.Check my eligibility
What is being tested?
The study tests if isatuximab combined with standard drugs (lenalidomide, bortezomib injection, dexamethasone) is safe and effective for treating new cases of multiple myeloma. Participants will receive this combination therapy before potentially undergoing a stem cell transplant.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components; increased risk of infections; blood clots; nerve damage that can cause pain or numbness; heart problems like irregular heartbeat or heart failure; high blood sugar levels from steroids; and digestive issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple myeloma and need treatment now.
Select...
My kidneys are functioning well enough (creatinine clearance ≥ 30 mL/min).
Select...
I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ induction to up to 3.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~induction to up to 3.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
stringent Complete Response (sCR)
Secondary outcome measures
Duration of Response
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v 5.0
Overall Survival
+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%
Renal Failure
2%
Lower Respiratory Tract Infection
2%
Hypercalcaemia
2%
Oral Herpes
2%
Productive Cough
2%
General Physical Health Deterioration
2%
Lung Infection
1%
Renal Aneurysm
1%
Orthostatic Hypotension
1%
Diabetic Ulcer
1%
Spinal Compression Fracture
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: Isa-RVDExperimental Treatment4 Interventions
The main study consists of 4 phases a) 28-day screening phase; b) an induction phase inclusive of two 42-day induction treatment cycles: Isatuximab (IV), Bortezomib (SQ). Lenalidomide (PO), Dexamethasone; c) Followed by stem cell mobilization (at the discretion of the Principal Investigator [PI]);d) Participants will proceed with either autologous stem cell transplant or two additional induction cycles.
- Induction will be followed by a maintenance phase that continues until disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isatuximab
FDA approved
Lenalidomide
FDA approved
Bortezomib
FDA approved
Dexamethasone
FDA approved
Find a Location
Who is running the clinical trial?
Jacob Laubach, MDLead Sponsor
SanofiIndustry Sponsor
2,163 Previous Clinical Trials
3,512,451 Total Patients Enrolled
47 Trials studying Multiple Myeloma
10,172 Patients Enrolled for Multiple Myeloma
Jacob LaubachLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot tolerate blood clot prevention treatments.Your blood platelet count is at least 75,000 cells/dL if less than half of your bone marrow cells are plasma cells, or at least 30,000 cells/dL if half or more of your bone marrow cells are plasma cells, without needing a blood transfusion in the 3 days before the screening test.You have a high level of M protein in your blood.I have an active hepatitis B or C infection.I have been diagnosed with multiple myeloma and need treatment now.I have amyloidosis or plasma cell leukemia with symptoms.I agree to use contraception or practice abstinence during and for 3 months after the study.You are allergic to steroids or H2 blockers, which are necessary for the treatment.My kidneys are functioning well enough (creatinine clearance ≥ 30 mL/min).I am allergic to dexamethasone or ingredients in the study medication.I can take care of myself but might not be able to do heavy physical work.I haven't had major surgery or radiation in the last 4 weeks, except for bone pain treatment.Your hemoglobin level is 8 g/dL or lower.My cancer has spread to my brain or spinal cord.I haven't needed strong infection treatment in the last 14 days.I've been taking more than 10 mg/day of corticosteroids for over a week.I have POEMS syndrome.You need to have a certain level of a type of white blood cell called neutrophils in your blood.I am not pregnant or breastfeeding and will use 2 forms of birth control during the study.You have more than 200 milligrams of M protein in your urine over a 24-hour period.Your disease can be measured and tracked using specific criteria.Your blood test shows high levels of a protein called free light chain and an abnormal ratio of this protein in your blood.Your total bilirubin level in the blood needs to be below a certain number, unless you have a condition called Gilbert Syndrome, in which case it can be a little higher.Your liver enzyme levels (AST and ALT) should be no more than 3 times the upper limit of normal.I have received treatment for multiple myeloma before.I haven't had cancer, except for certain skin cancers or low-risk prostate cancer treated over 3 years ago.I am 75 or younger. If over 70, my participation is approved by the principal investigator.I do not have any uncontrolled heart or blood pressure problems.My doctor has approved me for a stem cell transplant.I have severe nerve pain or numbness.
Research Study Groups:
This trial has the following groups:- Group 1: Isa-RVD
Awards:
This trial has 3 awards, including:- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
To what extent does Isatuximab pose a risk to patients?
"Isatuximab was assigned a rating of 2 since the clinical trial is still in Phase II, and thus there are only preliminary safety findings with no efficacy data yet."
Answered by AI
What medical conditions is Isatuximab typically prescribed to treat?
"Isatuximab is commonly administered to address ophthalmia, sympathetic. It has been used to successfully treat branch retinal vein occlusion and macular edema in addition to being a viable option after two prior systemic chemotherapy regimens."
Answered by AI
How many subjects are being monitored as part of this clinical experiment?
"Affirmative. According to the information provided on clinicaltrials.gov, this medical study is presently enrolling patients and has been since July 13th 2021. A total of 43 individuals are needed from one site for data collection purposes, with most recent updates made August 19th 2022."
Answered by AI
Is this research project actively recruiting participants at the moment?
"Affirmative. Clinicaltrials.gov's records demonstrate that this medical experiment, initially posted on July 13th 2021, is currently recruiting participants. A total of 43 people must be sourced from a single clinical site."
Answered by AI
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