Your session is about to expire
← Back to Search
Corticosteroid
Isa-Rd Combo Therapy for Multiple Myeloma
Phase 2
Recruiting
Led By Sascha Tuchman, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Measurable MM diagnosed according to standard criteria.
One or more MM-related organ dysfunction findings such as hypercalcemia, renal insufficiency, anemia, and bone lesions (CRAB) criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 of study treatment up to 60 months
Awards & highlights
Study Summary
This trial is looking at a new, lower-dose combo of drugs for myeloma. It hasn't been approved by the FDA yet.
Who is the study for?
This trial is for older or frail patients with newly diagnosed multiple myeloma who haven't had more than 28 days of anti-myeloma therapy. They must be at high risk for severe side effects from standard treatments, have measurable MM and related organ dysfunction, and show adequate organ function. Women of childbearing age must use birth control.Check my eligibility
What is being tested?
The study tests a combination of isatuximab, lenalidomide, and dexamethasone at lower doses than usual to see if it's safe and effective for treating new multiple myeloma cases while minimizing side effects. This approach isn't FDA-approved yet.See study design
What are the potential side effects?
Potential side effects may include reactions to the drugs like allergies or infusion-related issues, blood disorders due to bone marrow suppression by lenalidomide or dexamethasone, increased infection risk, fatigue, digestive problems from oral medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My multiple myeloma can be measured and has been diagnosed.
Select...
I have organ issues related to my multiple myeloma, like high calcium, kidney problems, anemia, or bone damage.
Select...
My tests show markers for myeloma cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from day 1 of study treatment up to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 of study treatment up to 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Clinical Benefit Rate (minimal response (MR) + ORR)
Duration of Response
Maximum Depth of Response
+7 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
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment3 Interventions
All subjects will receive the same treatment on the study, consisting of isatuximab, lenalidomide, and dexamethasone with 28 days cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Lenalidomide
2005
Completed Phase 3
~1480
Isatuximab
2016
Completed Phase 3
~370
Find a Location
Who is running the clinical trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,283 Total Patients Enrolled
17 Trials studying Multiple Myeloma
21,962 Patients Enrolled for Multiple Myeloma
Genzyme, a Sanofi CompanyIndustry Sponsor
524 Previous Clinical Trials
85,579 Total Patients Enrolled
27 Trials studying Multiple Myeloma
9,764 Patients Enrolled for Multiple Myeloma
Sascha Tuchman, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
1 Previous Clinical Trials
2,000 Total Patients Enrolled
1 Trials studying Multiple Myeloma
2,000 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a serious infection or needed antibiotics in the last 14 days.I have a stomach or bowel condition that affects how I absorb pills or tolerate certain medications.You are allergic to certain ingredients in the study treatment and cannot take medication to prevent an allergic reaction.My organ functions and lab tests meet the required standards.I haven't had a heart attack in the last 3 months and don't have severe heart issues.I am not using other cancer treatments, except possibly low-impact ones for past breast cancer.My multiple myeloma can be measured and has been diagnosed.I am at high risk for severe side effects from strong cancer treatments.You have HIV or an active infection with hepatitis A, B, or C, or tuberculosis.I haven't had long-term myeloma treatment before.I take more than a low dose of daily corticosteroids for a condition that is not multiple myeloma.I have had another type of cancer, but it won't affect this treatment's safety or results.I can confirm I am not pregnant and will use two forms of birth control or abstain from sex.I have organ issues related to my multiple myeloma, like high calcium, kidney problems, anemia, or bone damage.My tests show markers for myeloma cancer.My doctor thinks I can't handle standard treatments due to my health condition.I have been diagnosed with light-chain amyloidosis.I can start the study 14 days after finishing my radiotherapy.I am not on any medication that cannot be stopped or replaced as per the trial's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
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.
Are there any open positions for trial participants at this time?
"This trial, which is currently recruiting patients and was originally posted on February 18th, 2022, as indicated by clinicaltrials.gov."
Answered by AI
What are the most significant findings from other research on Isatuximab?
"Isatuximab was first studied 18 years ago at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. So far, 1350 completed clinical trials have occurred with 741 more currently recruiting patients. Many of these ongoing studies are based in Chapel Hill, North carolina."
Answered by AI
What is the main purpose of Isatuximab?
"Isatuximab is a common treatment for ophthalmia, sympathetic. Additionally, this medication can help patients who have undergone at least two systemic chemotherapy regimens, branch retinal vein occlusion, and macular edema."
Answered by AI
Has Isatuximab been cleared by the FDA for public use?
"Isatuximab's safety is unknown but there is some evidence from Phase 2 clinical trials that it might be safe."
Answered by AI
How many people with the condition are eligible for this treatment?
"That is accurate. The clinical trial in question, which was initially posted on February 18th, 2022, is still recruiting patients. They are looking for a total of 50 individuals between 3 different locations."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger