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Proteasome Inhibitor
Quadruple Therapy for Multiple Myeloma
Phase 2
Recruiting
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
Must not have
Inability to tolerate thromboprophylaxis
Active hepatitis B or hepatitis C viral infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up induction to up to 3.5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 60 Other Conditions
No Placebo-Only Group
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot tolerate blood clot prevention treatments.
Select...
I have an active hepatitis B or C infection.
Select...
I have amyloidosis or plasma cell leukemia with symptoms.
Select...
I am allergic to dexamethasone or ingredients in the study medication.
Select...
My cancer has spread to my brain or spinal cord.
Select...
I've been taking more than 10 mg/day of corticosteroids for over a week.
Select...
I have POEMS syndrome.
Select...
I have received treatment for multiple myeloma before.
Select...
I do not have any uncontrolled heart or blood pressure problems.
Select...
I have severe nerve pain or numbness.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
stringent Complete Response (sCR)
Secondary study objectives
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%
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
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
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: 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
Bortezomib
FDA approved
Dexamethasone
FDA approved
Isatuximab
FDA approved
Lenalidomide
FDA approved
Find a Location
Who is running the clinical trial?
Jacob Laubach, MDLead Sponsor
SanofiIndustry Sponsor
2,209 Previous Clinical Trials
4,039,714 Total Patients Enrolled
49 Trials studying Multiple Myeloma
9,754 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:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- 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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