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Proteasome Inhibitor

Quadruple Therapy for Multiple Myeloma (VICD Trial)

Phase 2
Recruiting
Led By Binod Dhakal, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects ≥18 years
Patients must be eligible for high-dose therapy and autologous stem cell transplantation as per institutional guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 100 days following autologous stem cell transplant
Awards & highlights

VICD Trial Summary

This trial is testing a new cancer drug. It's open-label, which means participants know what drug they're taking, and it's single-arm, which means everyone gets the same treatment. The safety lead-in phase is to make sure the drug is safe before giving it to everyone in the trial.

Who is the study for?
This trial is for adults with multiple myeloma who haven't had much prior treatment, can perform daily activities (ECOG 0-2), and have measurable disease. They must be able to give consent, agree to use contraception if necessary, and be eligible for stem cell transplantation. Exclusions include other cancers, central nervous system involvement by myeloma, significant heart issues or other conditions that could affect the study.Check my eligibility
What is being tested?
The trial tests a combination of drugs: Bortezomib, Isatuximab, Cyclophosphamide and Dexamethasone in patients eligible for stem cell transplant. It's an open-label phase II study which means everyone gets the same treatment and both doctors and patients know what's being given.See study design
What are the potential side effects?
Possible side effects include nausea from Cyclophosphamide; nerve damage from Bortezomib; infusion reactions from Isatuximab; insomnia or increased blood sugar levels from Dexamethasone. Each drug has its own set of potential side effects that may vary among individuals.

VICD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am eligible for a high-dose therapy and stem cell transplant according to my hospital's rules.
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I am a man and will use effective contraception or practice abstinence.
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I am able to get out of my bed or chair and move around.
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I have only had limited treatment for my multiple myeloma.
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I have multiple myeloma with certain blood cell levels or organ damage.
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I am a woman who is either postmenopausal, surgically sterile, or willing to use birth control.

VICD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~100 days following autologous stem cell transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 100 days following autologous stem cell transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The number of subjects who achieve very good partial response.
Secondary outcome measures
The number of subjects who achieve complete response.
The number of subjects who achieve partial response.

Side effects data

From 2023 Phase 3 trial • 307 Patients • NCT02990338
35%
Neutropenia
21%
Fatigue
21%
Pneumonia
21%
Diarrhoea
20%
Constipation
19%
Upper Respiratory Tract Infection
19%
Asthenia
16%
Back Pain
13%
Pyrexia
12%
Oedema Peripheral
12%
Arthralgia
11%
Thrombocytopenia
11%
Bronchitis
11%
Muscle Spasms
9%
Dyspnoea
9%
Urinary Tract Infection
9%
Insomnia
9%
Nausea
9%
Bone Pain
7%
Nasopharyngitis
7%
Peripheral Sensory Neuropathy
7%
Cough
7%
Cataract
7%
Pruritus
6%
Headache
6%
Fall
5%
Disease Progression
5%
Hypertension
5%
Decreased Appetite
5%
Tremor
5%
Rash
5%
Muscular Weakness
5%
Musculoskeletal Chest Pain
4%
Influenza
4%
Abdominal Pain
4%
Acute Kidney Injury
4%
Vomiting
3%
Pneumocystis Jirovecii Pneumonia
3%
Febrile Neutropenia
3%
Oropharyngeal Pain
3%
Septic Shock
3%
Pathological Fracture
3%
Dizziness
3%
Stomatitis
3%
Myalgia
3%
Pain In Extremity
2%
Hypercalcaemia
2%
Oral Herpes
2%
Productive Cough
2%
General Physical Health Deterioration
2%
Renal Failure
2%
Lung Infection
2%
Lower Respiratory Tract Infection
1%
Haemorrhage Intracranial
1%
Syncope
1%
Cardiac Failure
1%
Atrial Fibrillation
1%
Cerebral Haemorrhage
1%
Cauda Equina Syndrome
1%
Diverticulitis
1%
Escherichia Sepsis
1%
Gastroenteritis
1%
Respiratory Tract Infection
1%
Anaemia
1%
Dehydration
1%
Ischaemic Stroke
1%
Orthostatic Hypotension
1%
Pleural Effusion
1%
Pulmonary Embolism
1%
Pulmonary Oedema
1%
Respiratory Failure
1%
Pancreatitis Acute
1%
Death
1%
Accidental Overdose
1%
Diabetic Ulcer
1%
Pneumonia Bacterial
1%
Pneumonia Fungal
1%
Pyelonephritis
1%
Pyelonephritis Acute
1%
Sepsis
1%
Sinusitis
1%
Hyperviscosity Syndrome
1%
Pancytopenia
1%
Malnutrition
1%
Sudden Death
1%
Femur Fracture
1%
Infusion Related Reaction
1%
Spinal Compression Fracture
1%
Cytomegalovirus Gastrointestinal Infection
1%
Pneumonia Haemophilus
1%
Pneumonia Influenzal
1%
Pneumonia Streptococcal
1%
Basal Cell Carcinoma
1%
Tumour Associated Fever
1%
Hyponatraemia
1%
Confusional State
1%
Bronchospasm
1%
Large Intestine Perforation
1%
Renal Aneurysm
1%
Weight Decreased
1%
Covid-19
1%
Covid-19 Pneumonia
1%
Candida Pneumonia
1%
Infection
1%
Presyncope
1%
Spinal Subdural Haematoma
1%
Retinal Detachment
1%
Vision Blurred
1%
Angina Pectoris
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)

VICD Trial Design

3Treatment groups
Experimental Treatment
Group I: Safety Lead-in Cohort AExperimental Treatment4 Interventions
Six transplant-eligible multiple myeloma patients with renal impairment will be enrolled. Bortezomib (1.5 mg/m^2) subcutaneous on days 1,8 and 15 Isatuximab (10 mg/kg) IV on days 1, 8, 15 and 22 Cyclophosphamide (250 mg/m^2) IV on days 1, 8 and 15 Dexamethasone 20 mg PO or IV (10 mg if >75 years) on days 1, 2, 8, 9,15,16, 22 and 23
Group II: Expansion Cohort BExperimental Treatment4 Interventions
20 transplant-eligible non-renal impairment multiple myeloma patients will be enrolled. Bortezomib (1.5 mg/m^2) subcutaneous on days 1, 8 and 15 Isatuximab (10 mg/kg) IV on days 1, 8, 15 and 22 Cyclophosphamide (250 mg/m^2) IV on days 1, 8 and 15 Dexamethasone 20 mg PO or IV (10 mg if >75 years) on days 1, 2, 8, 9,15,16, 22 and 23
Group III: Expansion Cohort AExperimental Treatment4 Interventions
15 transplant-eligible multiple myeloma patients with renal impairment will be enrolled. Bortezomib (1.5 mg/m^2)subcutaneous on days 1, 8 and 15 Isatuximab (10 mg/kg) IV on days 1, 8, 15 and 22 Cyclophosphamide (250 mg/m^2) IV on days 1, 8 and 15 Dexamethasone 20 mg PO or IV (10 mg if >75 years) on days 1, 2, 8, 9,15,16, 22 and 23
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Bortezomib
2005
Completed Phase 2
~1140
Isatuximab
2016
Completed Phase 3
~370
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
608 Previous Clinical Trials
1,162,470 Total Patients Enrolled
16 Trials studying Multiple Myeloma
1,685 Patients Enrolled for Multiple Myeloma
Binod Dhakal, MDPrincipal InvestigatorMedical College of Wisconsin
3 Previous Clinical Trials
83 Total Patients Enrolled
3 Trials studying Multiple Myeloma
83 Patients Enrolled for Multiple Myeloma

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04240054 — Phase 2
Multiple Myeloma Research Study Groups: Safety Lead-in Cohort A, Expansion Cohort A, Expansion Cohort B
Multiple Myeloma Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT04240054 — Phase 2
Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04240054 — Phase 2

Frequently Asked Questions

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

Has Isatuximab been given the nod of approval from the FDA?

"Despite being in the early stages of clinical testing, isatuximab has sufficient safety data for our team at Power to rate its level of risk as a 2. However, there is yet no evidence that this medication can be effective."

Answered by AI

For what maladies is Isatuximab typically prescribed?

"Isatuximab has demonstrated efficacy in treating synovitis, ophthalmia, sympathetic inflammation, and a variety of lung cancers."

Answered by AI

Is there any availability to enroll in this clinical experiment?

"Affirmative. Per the clinicaltrials.gov records, this medical trial is currently searching for subjects and was initially posted on November 2nd 2021. Modifications were most recently made on March 14th 2022 and 41 patients are needed between two sites of research."

Answered by AI

Can you elucidate which research activities have featured Isatuximab?

"Isatuximab was first experimented with in 1997 by City of Hope Comprehensive Cancer Center. 2326 trials have since been completed, while 1322 are still active and recruiting patients - many occurring in Chicago, Illinois."

Answered by AI

Approximately how many volunteers are partaking in this trial?

"Affirmative. Evident on clinicaltrials.gov is this study's active search for participants, which began in November 2nd 2021 and was last modified today (March 14th 2022). This investigation requires 41 individuals from two medical centres."

Answered by AI
~17 spots leftby Dec 2025