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Alkylating agents
Isatuximab + Bendamustine + Prednisone for Multiple Myeloma
Phase 1
Waitlist Available
Led By Ravi Vij, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years after removal from study (estimated to be 5 years and 6 months)
Awards & highlights
Study Summary
This trial will study the combination of isatuximab with bendamustine and prednisone in people with relapsed/refractory multiple myeloma (a cancer of the plasma cells). The goal is to find the highest dose of the combination that can be given safely and to see if the combination can help control the cancer.
Who is the study for?
This trial is for adults with multiple myeloma that's hard to treat and has come back after other treatments. They should have measurable signs of the disease, be in fairly good health, and not pregnant or breastfeeding. They must agree to use birth control and sign a consent form. People who've had certain other cancers, serious illnesses, or specific treatments can't join.Check my eligibility
What is being tested?
Researchers are testing a new combo treatment for tough cases of multiple myeloma using Isatuximab (targets cancer cells), Bendamustine (chemotherapy), and Prednisone (steroid). First they'll find the highest dose people can take without bad side effects, then see how well it works.See study design
What are the potential side effects?
Possible side effects include reactions where the drug enters the body, low blood counts leading to higher infection risk or bleeding problems, nausea, fatigue, allergic reactions to ingredients in the drugs like sucrose or polysorbate 80.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of treatment through 30 days after completion of treatment or initiation of new anti-myeloma therapy, whichever occurs first (estimated to be 7 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment through 30 days after completion of treatment or initiation of new anti-myeloma therapy, whichever occurs first (estimated to be 7 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of regimen (Phase I only)
Overall response rate (ORR) (Phase II only)
Secondary outcome measures
Number of adverse events experienced by participants (Phase I and Phase II)
Overall survival (OS) (Phase II only)
Progression-free survival (PFS) (Phase II only)
Side 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%
Orthostatic Hypotension
1%
Diabetic Ulcer
1%
Spinal Compression Fracture
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
4Treatment groups
Experimental Treatment
Group I: Phase II: Isatuximab + Bendamustine + PrednisoneExperimental Treatment3 Interventions
-Isatuximab (10 mg/kg) on Days 1, 8, 15, and 22 during Cycle 1 and on Days 1 and 15 of subsequent cycles. Bendamustine (dose determined in Phase I portion of study) will be administered on Days 1 and 2 and prednisone (60 mg) will be administered on Days 1 through 4 of each cycle.
Group II: Phase I Dose Level 3: Isatuximab + Bendamustine + PrednisoneExperimental Treatment3 Interventions
-Isatuximab (10 mg/kg) on Days 1, 8, 15, and 22 during Cycle 1 and on Days 1 and 15 of subsequent cycles. Bendamustine (100 mg/m^2) will be administered on Days 1 and 2 and prednisone (60 mg) will be administered on Days 1 through 4 of each cycle.
Group III: Phase I Dose Level 2: Isatuximab + Bendamustine + PrednisoneExperimental Treatment3 Interventions
-Isatuximab (10 mg/kg) on Days 1, 8, 15, and 22 during Cycle 1 and on Days 1 and 15 of subsequent cycles. Bendamustine (75 mg/m^2) will be administered on Days 1 and 2 and prednisone (60 mg) will be administered on Days 1 through 4 of each cycle.
Group IV: Phase I Dose Level 1: Isatuximab + Bendamustine + PrednisoneExperimental Treatment3 Interventions
-Isatuximab (10 mg/kg) on Days 1, 8, 15, and 22 during Cycle 1 and on Days 1 and 15 of subsequent cycles. Bendamustine (50 mg/m^2) will be administered on Days 1 and 2 and prednisone (60 mg) will be administered on Days 1 through 4 of each cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isatuximab
2016
Completed Phase 3
~370
Bendamustine
2015
Completed Phase 3
~2950
Prednisone
2014
Completed Phase 4
~2370
Find a Location
Who is running the clinical trial?
SanofiIndustry Sponsor
2,163 Previous Clinical Trials
3,512,465 Total Patients Enrolled
47 Trials studying Multiple Myeloma
10,186 Patients Enrolled for Multiple Myeloma
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,694 Total Patients Enrolled
31 Trials studying Multiple Myeloma
2,202 Patients Enrolled for Multiple Myeloma
Ravi Vij, M.D.Principal InvestigatorWashington University School of Medicine
17 Previous Clinical Trials
579 Total Patients Enrolled
9 Trials studying Multiple Myeloma
374 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with isatuximab or bendamustine.I have HIV but my CD4+ T-cell count is above 350 and I haven't had a major infection in the last year.I have been diagnosed with multiple myeloma and it can be measured.I have another cancer that needs treatment.I am on dialysis.You currently have hepatitis A, B, or C.My bone marrow and organs are functioning normally.I am allergic to certain ingredients in the study medication.I have had plasma cell leukemia or myeloma that spread to the brain.My condition is resistant to three types of cancer treatments.I can take care of myself but might not be able to do heavy physical work.I agree to avoid pregnancy and use birth control during and for 3 months after the study.I do not have any serious illnesses like heart problems or infections.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Phase II: Isatuximab + Bendamustine + Prednisone
- Group 2: Phase I Dose Level 3: Isatuximab + Bendamustine + Prednisone
- Group 3: Phase I Dose Level 2: Isatuximab + Bendamustine + Prednisone
- Group 4: Phase I Dose Level 1: Isatuximab + Bendamustine + Prednisone
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 prior studies have been executed to assess the effects of Isatuximab?
"Presently, there are an impressive 447 clinical trials being conducted that involve Isatuximab with 117 of those in the final stages. While many of these studies center around Duarte, California, a grand total of 22188 sites host such research initiatives."
Answered by AI
How many participants have enrolled in this experiment?
"Affirmative. Evidence hosted on clinicaltrials.gov affirms that this medical research effort, which was first posted in April 3rd 2020, is actively seeking participants. Approximately 37 individuals must be enrolled from 1 different health centre."
Answered by AI
Is it possible to join this medical experiment at present?
"The latest information from clinicaltrials.gov shows that this medical trial is still recruiting eligible participants, which began on April 3rd 2020 and was last updated on September 21st 2022."
Answered by AI
For what illnesses is Isatuximab generally prescribed?
"Isatuximab has shown to be efficacious in treating ulcerative colitis. It can also prove beneficial for those afflicted with varicella-zoster virus acute retinal necrosis, brain, and iritis."
Answered by AI
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