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Monoclonal Antibodies

Isatuximab for Smoldering Multiple Myeloma

Phase 2

Waitlist Available

Led By Elisabet E Manasanch

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must meet criteria for high risk of progression to multiple myeloma by PETHEMA criteria (patients must have at least 2 risk factors present)

Age ≥ 18 years

Must not have

Radiotherapy is not permitted

Uncontrolled intercurrent illness including hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how well a monoclonal antibody called isatuximab works in treating patients with smoldering plasma cell myeloma that is high risk.

Who is the study for?

Adults over 18 with high risk smoldering plasma cell myeloma, showing specific levels of monoclonal protein or bone marrow plasma cells. They must be at high risk for developing multiple myeloma and have good kidney, liver, and blood health. Women who can bear children and men with partners who can must use birth control. Exclusions include HIV, recent major surgery, uncontrolled diseases like heart failure or hypertension, prior treatments for this condition, pregnancy or breastfeeding.

What is being tested?

The trial is testing Isatuximab's effectiveness in patients with a pre-cancerous condition called high risk smoldering plasma cell myeloma. It's an immunotherapy that may help the immune system prevent tumor growth and spread. The study includes monitoring through lab biomarker analysis to see how well it works.

What are the potential side effects?

While not explicitly listed here, side effects of Isatuximab could include infusion reactions (like fever or chills), low blood counts leading to increased infection risks or bleeding problems, fatigue, nausea and potential allergic reactions due to its nature as a monoclonal antibody.

Eligibility Criteria

Inclusion Criteria

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

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I am at high risk of my condition progressing to multiple myeloma according to PETHEMA criteria.

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I am 18 years old or older.

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I am able to get out of my bed or chair and move around.

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I have SMM with specific protein levels in my blood or urine, or a certain percentage of plasma cells in my bone marrow.

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My liver tests are within normal limits.

Exclusion Criteria

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

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I have not undergone radiotherapy.

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I do not have any uncontrolled illnesses like high blood pressure or heart problems.

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My kidney function is reduced with specific test results.

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I have not had major surgery in the last month.

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I have one or more bone lesions detectable by scans.

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I am not allergic or unable to take any medication required before therapy.

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I do not have an uncontrolled lung condition.

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I have not used chemotherapy or CD38 drugs for smoldering multiple myeloma.

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I do not have an active hepatitis B or C infection.

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I have been diagnosed with plasma cell leukemia.

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I am not currently receiving any other cancer treatments.

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I am HIV positive.

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My tests show signs of myeloma or cancerous cell growth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall response (>= partial response)

Secondary study objectives

Incidence of adverse events

Overall survival

Progression free survival

Other study objectives

Genetic polymorphisms

Immune characterization

Mechanisms of resistance to isatuximab

+2 more

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

Pleural Effusion

Haemorrhage Intracranial

Infusion Related Reaction

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

1Treatment groups

Experimental Treatment

Group I: Treatment (isatuximab)Experimental Treatment2 Interventions

Patients receive isatuximab IV over 5 hours on day 1 of cycle 1, and over 3 hours thereafter on days 8, 15, and 22 of cycle 1, on days 1 and 15 of cycles 2-6, and on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 30 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Isatuximab

2016

Completed Phase 3

~370

0 / 18Eligibility criteria met