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Monoclonal Antibodies

Isatuximab + Standard Therapy for Multiple Myeloma

Phase 2
Waitlist Available
Research Sponsored by Canadian Myeloma Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status score of 0, 1 or 2
Females of childbearing potential (FCBP): a female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 100 days
Awards & highlights

Study Summary

This trial will test a new cancer drug given with two other drugs to see if it is safe and effective.

Who is the study for?
This trial is for adults aged 18-75 with newly diagnosed symptomatic Multiple Myeloma who have a life expectancy of at least 9 months and meet specific health criteria. Participants must not be pregnant, breastfeeding, or planning to become pregnant and agree to use effective contraception methods. They should not have had prior treatments for MM except certain steroids, no known HIV/hepatitis B/C, CNS involvement, or severe heart conditions.Check my eligibility
What is being tested?
The study tests Isatuximab combined with CyBorD induction treatment and Lenalidomide maintenance in patients eligible for autologous stem cell transplant. It's an open-label phase II trial where all participants receive the same treatment over a series of 28-day cycles to assess safety and effectiveness.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion such as fever or chills, low blood counts which can increase infection risk, fatigue, nausea, potential allergic reactions if sensitive to monoclonal antibodies or their components like mannitol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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I am a woman capable of becoming pregnant.
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I agree to use two reliable birth control methods or abstain from sex for specific periods before and after the study.
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I have been recently diagnosed with symptomatic multiple myeloma.
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I agree not to donate semen during and for 150 days after the study.
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I agree not to donate blood during and for 28 days after the study.
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I agree to use a condom during sexual activity for 150 days after the study ends.
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I agree not to breastfeed during the study and for 150 days after stopping the study drug.
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I am between 18 and 75 years old.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Response rate (VGPR or better) defined by IMWG criteria

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)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Isatuximab with CyBorD and Lenalidomide MaintenanceExperimental Treatment1 Intervention
This is a single arm study of Isatuximab administered intravenously in combination with cyclophosphamide, bortezomib and dexamethasone (CyBorD), and Lenalidomide maintenance treatment

Find a Location

Who is running the clinical trial?

Canadian Myeloma Research GroupLead Sponsor
6 Previous Clinical Trials
431 Total Patients Enrolled
6 Trials studying Multiple Myeloma
431 Patients Enrolled for Multiple Myeloma

Media Library

Isatuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04786028 — Phase 2
Multiple Myeloma Research Study Groups: Isatuximab with CyBorD and Lenalidomide Maintenance
Multiple Myeloma Clinical Trial 2023: Isatuximab Highlights & Side Effects. Trial Name: NCT04786028 — Phase 2
Isatuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04786028 — Phase 2

Frequently Asked Questions

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

Are patients still being recruited for this trial?

"Yes, this is an ongoing study that is currently seeking 65 subjects at 10 different clinical trial sites. The original posting was on December 8th, 2021 with the most recent update being February 14th, 2022."

Answered by AI

How many people fit the eligibility criteria for this research project?

"The clinical trial is actively recruiting patients, with 65 participants needed from 10 locations. The trial was posted on December 8th, 2021 and last edited February 14th, 2022."

Answered by AI

When was Isatuximab cleared by the FDA?

"Isatuximab's safety is estimated to be a 2 because, while there is data indicating it is safe, there is no current evidence that the medication is effective."

Answered by AI

Where can patients enroll in this clinical trial?

"To limit the amount of travelling required for participants, this clinical trial is being conducted out of 10 locations. These include cities such as Saskatoon, Winnipeg and Toronto."

Answered by AI
~33 spots leftby Mar 2026