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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

Patients must be eligible for high-dose therapy and autologous stem cell transplantation as per institutional guidelines

Male subjects who agree to use effective barrier contraception or practice true abstinence

Must not have

Had major surgery within two weeks before Cycle 1, Day 1, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study or within two weeks after the last dose of study drug administration

Clinically significant cardiac disease, including specific conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 100 days following autologous stem cell transplant

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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 multiple myeloma with certain blood cell levels or organ damage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had major surgery within the last two weeks and don't plan any during the study.

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I do not have any serious heart conditions.

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My multiple myeloma has affected my brain or spinal cord.

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I have a blood disorder.

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I have a lung condition that is not well-managed.

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I need immediate treatment for my kidney failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 100 days following autologous stem cell transplant

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The number of subjects who achieve very good partial response.

Secondary study objectives

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%

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

Dyspnoea

Insomnia

Nausea

Urinary Tract Infection

Bone Pain

Cough

Nasopharyngitis

Peripheral Sensory Neuropathy

Cataract

Pruritus

Fall

Headache

Hypertension

Disease Progression

Decreased Appetite

Tremor

Muscular Weakness

Musculoskeletal Chest Pain

Rash

Acute Kidney Injury

Influenza

Abdominal Pain

Vomiting

Pneumocystis Jirovecii Pneumonia

Febrile Neutropenia

Pathological Fracture

Oropharyngeal Pain

Myalgia

Pain In Extremity

Septic Shock

Dizziness

Stomatitis

Renal Failure

Lower Respiratory Tract Infection

Hypercalcaemia

General Physical Health Deterioration

Oral Herpes

Productive Cough

Lung Infection

Infusion Related Reaction

Pleural Effusion

Haemorrhage Intracranial

Pulmonary Embolism

Renal Aneurysm

Sudden Death

Pneumonia Fungal

Covid-19 Pneumonia

Candida Pneumonia

Diverticulitis

Escherichia Sepsis

Cytomegalovirus Gastrointestinal Infection

Gastroenteritis

Tumour Associated Fever

Syncope

Dehydration

Respiratory Tract Infection

Basal Cell Carcinoma

Anaemia

Hyponatraemia

Confusional State

Malnutrition

Cerebral Haemorrhage

Angina Pectoris

Cauda Equina Syndrome

Ischaemic Stroke

Atrial Fibrillation

Cardiac Failure

Orthostatic Hypotension

Pulmonary Oedema

Respiratory Failure

Pancreatitis Acute

Diabetic Ulcer

Death

Accidental Overdose

Spinal Compression Fracture

Weight Decreased

Pneumonia Bacterial

Pyelonephritis

Pyelonephritis Acute

Sepsis

Sinusitis

Hyperviscosity Syndrome

Pancytopenia

Femur Fracture

Pneumonia Haemophilus

Pneumonia Influenzal

Pneumonia Streptococcal

Bronchospasm

Large Intestine Perforation

Covid-19

Infection

Presyncope

Spinal Subdural Haematoma

Retinal Detachment

Vision Blurred

Myocardial Infarction

Deep Vein Thrombosis

Ataxia

100%

80%

60%

40%

20%

Study treatment Arm

Pd (Pomalidomide + Dexamethasone)

IPd (Isatuximab + Pomalidomide + Dexamethasone)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Dexamethasone

2007

Completed Phase 4

~2650

Bortezomib

2005

Completed Phase 3

~1410