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Proteasome Inhibitor

Isatuximab + Velcade + Dexamethasone for Multiple Myeloma with Kidney Disease

Phase 1
Waitlist Available
Led By Keith Stockerl-Goldstein, 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
This study will enroll 28 evaluable patients. Fourteen (+/- 2) patients will be required to be on dialysis and 14 (+/- 2) patients will not be on dialysis.
At least 18 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of cycle 3 for all enrolled patients (estimated to be 39 months)
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat multiple myeloma in patients with severe kidney problems. The goal is to see if it is safe and effective.

Who is the study for?
This trial is for adults with newly diagnosed multiple myeloma who have severe kidney disease, including those on dialysis. They should be in relatively good health otherwise (ECOG ≤ 2), not pregnant or breastfeeding, and willing to use contraception. People can't join if they've had bad reactions to bortezomib, have certain viral infections like active hepatitis B or C, are receiving other cancer treatments, or have a history of heart problems.Check my eligibility
What is being tested?
The study tests the combination of Isatuximab, Velcade (Bortezomib), and Dexamethasone in patients with multiple myeloma and severe kidney issues. It aims to find out how safe this mix is and how well it works when standard treatments might not be suitable due to poor kidney function.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs used; blood disorders like low platelet counts; potential heart issues such as arrhythmias; increased risk of infection; fatigue; digestive disturbances; and nerve damage that could cause pain or numbness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am either currently on dialysis or not on dialysis.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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My white blood cell count is high enough for treatment.
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My platelet count is at least 50,000/mm3, transfusions included.
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I can understand and am willing to sign the consent form.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of cycle 3 for all enrolled patients (estimated to be 39 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of cycle 3 for all enrolled patients (estimated to be 39 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of the regimen as measured by the proportion of patients that discontinue therapy before Cycle 3 for toxicity or intolerance
Secondary outcome measures
Change in quality of life as measured by the EORTC-QLQ 30 questionnaire
Duration of response (DOR)
Overall response rate (ORR) per IMWG criteria
+7 more

Side effects data

From 2023 Phase 3 trial • 307 Patients • NCT02990338
35%
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: Isatuximab + Boretezomib + DexamethasoneExperimental Treatment3 Interventions
Each cycle is 28 days Cycle 1 Days 1, 8, 15, and 22: Dexamethasone at start time, Bortezomib at 30 minutes after start time, and Isatuximab at 60 minutes after start time Cycles 2-8 Days 1 and 15: Dexamethasone at start time, Bortezomib at 30 minutes after start time, and Isatuximab at 60 minutes after start time Days 8 and 22: Dexamethasone at start time and Bortezomib at 30 minutes after start time Cycles 9+ Days 1 and 15: Dexamethasone at start time and Isatuximab at 30-60 minutes after start time
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isatuximab
2016
Completed Phase 3
~370
Bortezomib
2005
Completed Phase 2
~1140
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,708 Total Patients Enrolled
31 Trials studying Multiple Myeloma
2,216 Patients Enrolled for Multiple Myeloma
SanofiIndustry Sponsor
2,163 Previous Clinical Trials
3,512,479 Total Patients Enrolled
47 Trials studying Multiple Myeloma
10,200 Patients Enrolled for Multiple Myeloma
Keith Stockerl-Goldstein, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
51 Total Patients Enrolled
1 Trials studying Multiple Myeloma
51 Patients Enrolled for Multiple Myeloma

Media Library

Multiple Myeloma Research Study Groups: Isatuximab + Boretezomib + Dexamethasone

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What adverse effects could arise from Isatuximab usage?

"Due to limited data regarding efficacy and safety, Isatuximab has been rated a 1 on the scale of 1-3. This is because this trial is in its first phase."

Answered by AI

Is this research initiative open to participants at the present time?

"This clinical trial is currently seeking participants, as indicated on clinicaltrials.gov. It was first posted on April 1st 2022 and amended most recently on September 27th 2022."

Answered by AI

Could you please elucidate the other experiments involving Isatuximab that have been conducted?

"Currently, there are 607 active clinical trials for Isatuximab with the majority located in Phase 3. While Joliet, Illinois is a notable site running these studies, it represents only a fraction of the total 20414 locations currently researching this drug."

Answered by AI

What is the primary therapeutic application of Isatuximab?

"Isatuximab is often used to address ophthalmia, sympathetic. This medication can also be deployed in the treatment of branch retinal vein occlusion and macular edema, as well as communicable diseases."

Answered by AI

What is the aggregate population of participants in this research project?

"Affirmative. The information on clinicaltrials.gov reveals that recruitment for this trial is currently underway, having been announced on April 1st 2022 and last updated September 27th of the same year. 28 individuals are required to be enrolled at a single medical centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Isatuximab, Velcade, and Dexamethasone in Patients With Multiple Myeloma and Severe KIDNEY Disease
2022. "Isatuximab, Velcade, and Dexamethasone in Patients With Multiple Myeloma and Severe KIDNEY Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04912427.
~0 spots leftby Apr 2025
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