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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study 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.Check my eligibility
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).See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the total lymphocyte count
Secondary outcome measures
CD8 and CD4 Subsets
Number of Adverse Events
Percentage of Natural Killer (NK) cells
+3 moreSide effects data
From 2023 Phase 3 trial • 307 Patients • NCT0299033835%
Neutropenia
21%
Fatigue
21%
Diarrhoea
21%
Pneumonia
20%
Constipation
19%
Asthenia
19%
Upper Respiratory Tract Infection
16%
Back Pain
13%
Pyrexia
12%
Oedema Peripheral
12%
Arthralgia
11%
Bronchitis
11%
Thrombocytopenia
11%
Muscle Spasms
9%
Dyspnoea
9%
Nausea
9%
Insomnia
9%
Urinary Tract Infection
9%
Bone Pain
7%
Cough
7%
Cataract
7%
Nasopharyngitis
7%
Peripheral Sensory Neuropathy
7%
Pruritus
6%
Headache
6%
Fall
5%
Muscular Weakness
5%
Decreased Appetite
5%
Hypertension
5%
Tremor
5%
Musculoskeletal Chest Pain
5%
Disease Progression
5%
Rash
4%
Vomiting
4%
Acute Kidney Injury
4%
Influenza
4%
Abdominal Pain
3%
Myalgia
3%
Pathological Fracture
3%
Pain In Extremity
3%
Pneumocystis Jirovecii Pneumonia
3%
Febrile Neutropenia
3%
Oropharyngeal Pain
3%
Septic Shock
3%
Dizziness
3%
Stomatitis
2%
Lower Respiratory Tract Infection
2%
Renal Failure
2%
Hypercalcaemia
2%
Oral Herpes
2%
Productive Cough
2%
General Physical Health Deterioration
2%
Lung Infection
1%
Diabetic Ulcer
1%
Spinal Compression Fracture
1%
Orthostatic Hypotension
1%
Renal Aneurysm
1%
Malnutrition
1%
Respiratory Tract Infection
1%
Confusional State
1%
Cerebral Haemorrhage
1%
Haemorrhage Intracranial
1%
Atrial Fibrillation
1%
Tumour Associated Fever
1%
Hyponatraemia
1%
Cauda Equina Syndrome
1%
Angina Pectoris
1%
Cardiac Failure
1%
Covid-19 Pneumonia
1%
Syncope
1%
Pancreatitis Acute
1%
Sudden Death
1%
Cytomegalovirus Gastrointestinal Infection
1%
Infusion Related Reaction
1%
Candida Pneumonia
1%
Pneumonia Fungal
1%
Basal Cell Carcinoma
1%
Diverticulitis
1%
Escherichia Sepsis
1%
Gastroenteritis
1%
Anaemia
1%
Dehydration
1%
Ischaemic Stroke
1%
Pleural Effusion
1%
Pulmonary Embolism
1%
Pulmonary Oedema
1%
Respiratory Failure
1%
Death
1%
Accidental Overdose
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%
Weight Decreased
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)
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
524 Previous Clinical Trials
85,590 Total Patients Enrolled
27 Trials studying Multiple Myeloma
9,775 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for at least 6 more months.I have a specific type of blood cancer and am at a certain stage of treatment.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am about to have my first stem cell transplant.I have been treated with a CD38 antibody in the past year.I am HIV-positive.I haven't taken any experimental drugs in the last 8 weeks.I am 18 years old or older.You have had a severe allergic reaction to drugs similar to Isatuximab.I haven't received CD38 antibody treatment in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Isatuximab and Standard Procedures
- Group 2: Standard procedures
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor presently open to recruitment?
"The information on clinicaltrials.gov shows that this medical experiment is still actively recruiting, with the original post date being February 9th 2022 and the last update on October 26th of the same year."
Answered by AI
What dangers may be associated with Isatuximab treatment?
"Isatuximab's safety has been established in prior clinical trials, thus it was assigned a score of 2. This is due to the fact that Phase 2 research typically only confirms the efficacy of medications and does not measure long-term outcomes."
Answered by AI
How many individuals have enrolled to take part in this experiment?
"Affirmative. According to clinicaltrials.gov, this scientific experiment was first announced on 2/9/2022 and is currently recruiting volunteers. The research requires a total of 39 individuals from one facility."
Answered by AI
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