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Monoclonal Antibodies

Isatuximab with Stem Cell Transplant for Multiple Myeloma

Phase 2
Recruiting
Research Sponsored by Divaya Bhutani
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with the following diagnoses are eligible for inclusion in the study: Multiple Myeloma with ASCT used as consolidation after first line induction therapy or at first relapse, Relapsed Hodgkin's disease, Non-Hodgkin's Lymphomas including relapsed Diffuse large B cell lymphoma, relapsed indolent or relapsed transformed indolent B cell lymphomas as consolidation after second line therapy, Mantle Cell lymphoma as consolidation after first-line therapy, Peripheral T cell lymphoma as consolidation after first-line therapy or at relapse
Patients undergoing first ASCT will be eligible for the study
Must not have
Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
HIV-positive status due to increased risk of infection when treated with immunosuppressive therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing to see if a treatment can help the immune system fight cancer after a stem cell transplant. People are randomly assigned to either the experimental or control group.

Who is the study for?
This trial is for adults over 18 with multiple myeloma or lymphomas, including Hodgkin's and non-Hodgkin's types, who are undergoing their first stem cell transplant. They should not have used CD38 antibodies in the past year or be HIV-positive. Pregnant women and those with severe allergies to Isatuximab-like compounds, uncontrolled illnesses, or recent use of investigational drugs cannot participate.
What is being tested?
The study tests if adding Isatuximab to standard stem cell transplant procedures can better help the immune system fight cancer in patients recovering from transplantation. Participants will be randomly assigned to either receive standard care (control arm) or standard care plus Isatuximab (experimental arm).
What are the potential side effects?
While specific side effects for this trial aren't listed, common ones for Isatuximab may include infusion reactions like fever and chills, low blood counts increasing infection risk, nausea, diarrhea, fatigue and possibly allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a specific type of blood cancer and am at a certain stage of treatment.
Select...
I am about to have my first stem cell transplant.
Select...
I am 18 years old or older.
Select...
I haven't received CD38 antibody treatment in the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Select...
I am HIV-positive.
Select...
I haven't taken any experimental drugs in the last 8 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in the total lymphocyte count
Secondary study objectives
CD8 and CD4 Subsets
Number of Adverse Events
Percentage of Natural Killer (NK) cells
+3 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
9%
Dyspnoea
9%
Insomnia
9%
Nausea
9%
Urinary Tract Infection
9%
Bone Pain
7%
Cough
7%
Nasopharyngitis
7%
Peripheral Sensory Neuropathy
7%
Cataract
7%
Pruritus
6%
Fall
6%
Headache
5%
Hypertension
5%
Disease Progression
5%
Decreased Appetite
5%
Tremor
5%
Muscular Weakness
5%
Musculoskeletal Chest Pain
5%
Rash
4%
Acute Kidney Injury
4%
Influenza
4%
Abdominal Pain
4%
Vomiting
3%
Pneumocystis Jirovecii Pneumonia
3%
Febrile Neutropenia
3%
Pathological Fracture
3%
Oropharyngeal Pain
3%
Myalgia
3%
Pain In Extremity
3%
Septic Shock
3%
Dizziness
3%
Stomatitis
2%
Renal Failure
2%
Lower Respiratory Tract Infection
2%
Hypercalcaemia
2%
General Physical Health Deterioration
2%
Oral Herpes
2%
Productive Cough
2%
Lung Infection
1%
Infusion Related Reaction
1%
Pleural Effusion
1%
Haemorrhage Intracranial
1%
Pulmonary Embolism
1%
Renal Aneurysm
1%
Sudden Death
1%
Pneumonia Fungal
1%
Covid-19 Pneumonia
1%
Candida Pneumonia
1%
Diverticulitis
1%
Escherichia Sepsis
1%
Cytomegalovirus Gastrointestinal Infection
1%
Gastroenteritis
1%
Tumour Associated Fever
1%
Syncope
1%
Dehydration
1%
Respiratory Tract Infection
1%
Basal Cell Carcinoma
1%
Anaemia
1%
Hyponatraemia
1%
Confusional State
1%
Malnutrition
1%
Cerebral Haemorrhage
1%
Angina Pectoris
1%
Cauda Equina Syndrome
1%
Ischaemic Stroke
1%
Atrial Fibrillation
1%
Cardiac Failure
1%
Orthostatic Hypotension
1%
Pulmonary Oedema
1%
Respiratory Failure
1%
Pancreatitis Acute
1%
Diabetic Ulcer
1%
Death
1%
Accidental Overdose
1%
Spinal Compression Fracture
1%
Weight Decreased
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%
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard proceduresExperimental Treatment1 Intervention
Subjects will receive standard procedures for transplant.
Group II: Isatuximab and Standard ProceduresExperimental Treatment1 Intervention
Subjects will receive the study drug Isatuximab in addition to standard procedures for transplant
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isatuximab
2016
Completed Phase 3
~370

Find a Location

Who is running the clinical trial?

Divaya BhutaniLead Sponsor
Genzyme, a Sanofi CompanyIndustry Sponsor
527 Previous Clinical Trials
185,697 Total Patients Enrolled
29 Trials studying Multiple Myeloma
10,021 Patients Enrolled for Multiple Myeloma

Media Library

Isatuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05346809 — Phase 2
Multiple Myeloma Research Study Groups: Isatuximab and Standard Procedures, Standard procedures
Multiple Myeloma Clinical Trial 2023: Isatuximab Highlights & Side Effects. Trial Name: NCT05346809 — Phase 2
Isatuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05346809 — Phase 2
~3 spots leftby Mar 2025
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