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Corticosteroid
Isatuximab Combo for Multiple Myeloma
Phase 1
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant has been previously diagnosed with multiple myeloma (MM) based on standard criteria and currently requires treatment because MM has relapsed following a response, according to International Myeloma Working Group (IMWG) criteria.
Participant has received at least two previous therapies including lenalidomide and a proteasome inhibitor and has demonstrated disease progression on last therapy or after completion of the last therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 30 days after last study treatment administration (up to approximately 14 months after first study treatment administration)
Awards & highlights
Study Summary
This trial is testing a new drug, isatuximab, to see if it is safe and works well. The new drug will be given either by injection under the skin or through a vein.
Who is the study for?
Adults with relapsed/refractory multiple myeloma who've had at least two prior treatments, including lenalidomide and a proteasome inhibitor, are eligible. They must have measurable disease, be able to consent to the study's requirements, and use contraception. Exclusions include recent malignancy or therapy, uncontrolled medical conditions, inadequate organ function, no response to previous treatments, certain infections like HIV or hepatitis B/C, hypersensitivity to trial drugs' components or severe allergies.Check my eligibility
What is being tested?
The trial is testing how safe and tolerable the drug isatuximab is when given subcutaneously (SC) versus intravenously (IV), using an investigational injector device. It also looks at how the body processes the drug (pharmacokinetics), its bioavailability when injected under the skin compared to IV administration, receptor occupancy rates post-administration of SC vs IV doses as well as patient satisfaction with SC injections.See study design
What are the potential side effects?
Possible side effects from isatuximab may include reactions at injection sites for SC administration; infusion-related reactions for IV; plus potential impacts on blood counts leading to increased infection risk. Dexamethasone can cause mood swings and increase in blood sugar levels while pomalidomide may lead to fatigue and digestive issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My multiple myeloma has returned and needs treatment.
Select...
I've had at least two treatments including lenalidomide and a proteasome inhibitor, and my disease got worse after the last treatment.
Select...
I am over 18 or the legal age in my country and can consent.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycles 1 and 2 (28 days per cycle), and 30 days after last isatuximab administration (up to approximately 14 months after first study treatment administration)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycles 1 and 2 (28 days per cycle), and 30 days after last isatuximab administration (up to approximately 14 months after first study treatment administration)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of adverse events (AEs)
PK assessment: AUC0 T
PK assessment: AUClast
+6 moreSecondary outcome measures
Biomarker: Change in CD38 receptor occupancy
Clinical benefit rate (CBR)
Comparison of patient expectations and satisfaction: Patient Expectations and Satisfaction Questionnaires
+8 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Dose regimen 5Experimental Treatment3 Interventions
Isatuximab IV administration once weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle
Group II: Dose regimen 4Experimental Treatment3 Interventions
Isatuximab IV administration once weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle
Group III: Dose regimen 3Experimental Treatment4 Interventions
Isatuximab SC administration dose level 3 using the investigational injector device once weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle
Group IV: Dose regimen 2Experimental Treatment3 Interventions
Isatuximab SC administration dose level 2 once weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle
Group V: Dose regimen 1Experimental Treatment3 Interventions
Isatuximab SC administration dose level 1 once weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dexamethasone
1995
Completed Phase 3
~9860
pomalidomide
2011
Completed Phase 3
~1060
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,424 Total Patients Enrolled
47 Trials studying Multiple Myeloma
10,145 Patients Enrolled for Multiple Myeloma
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,019,243 Total Patients Enrolled
22 Trials studying Multiple Myeloma
4,147 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been refractory or intolerant to anti-CD38 treatment, nor progressed after it with less than 9 months before starting isatuximab.My multiple myeloma has returned and needs treatment.I had a stem cell transplant and am either experiencing Graft Versus Host Disease or have been on immunosuppressive therapy recently.My blood, liver, or kidney functions are not within normal ranges.I haven't had cancer treatment in the last 14 days.I've had at least two treatments including lenalidomide and a proteasome inhibitor, and my disease got worse after the last treatment.I don't have lasting side effects from past treatments, except for hair loss or mild nerve issues without pain.I cannot tolerate blood clot prevention treatments.I am over 18 or the legal age in my country and can consent.You have HIV, hepatitis A, active hepatitis B, or active hepatitis C.You have had a serious allergic reaction to certain medications that affect the immune system in the past.I am allergic to specific drugs or ingredients in the study therapy.You have to have a certain amount of abnormal proteins in your blood or urine for the study.My previous cancer treatment did not improve my condition.I do not have active tuberculosis or severe infections needing IV antibiotics.Your blood calcium level is higher than what is considered normal.I am using birth control.I can sign and follow the study's consent form and rules.I was diagnosed with cancer within the last 3 years.I need corticosteroids every day.My condition limits my ability to care for myself.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Dose regimen 2
- Group 2: Dose regimen 1
- Group 3: Dose regimen 5
- Group 4: Dose regimen 3
- Group 5: Dose regimen 4
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary purpose of administering Isatuximab SAR650984 intravenously?
"Isatuximab SAR650984 IV is a common remedy for ophthalmia, sympathetic and other diseases like communicable illnesses, macular edema, and branch retinal vein occlusion."
Answered by AI
What empirical evidence exists about the efficacy of isatuximab SAR650984 IV?
"SAR650984 IV, otherwise known as isatuximab, had its first clinical trial in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. To date there have been 1129 completed studies of the medication and 584 trials are still underway; with a significant number being conducted out of Gilbert, Arizona."
Answered by AI
What aims is the research endeavoring to accomplish?
"This clinical trial seeks to ascertain the safety of isatuximab by tracking adverse events throughout a Baseline-EOT and Cycle 10 time frame. Secondary outcomes include estimating the absolute bioavailability, measuring progression free survival rates, and comparing patient satisfaction before and after subcutaneous administration (with 1 being not satisfied and 5 as extremely satisfied)."
Answered by AI
How many individuals are involved in the research of this clinical trial?
"This investigation is not seeking patients at this moment. Originally published on August 6th 2019, the most recent update was made 5/6/2022 - so it may be inactive now. However, those interested in similar investigations can find 807 clinical trials for multiple myeloma and 584 studies regarding Isatuximab SAR650984 IV that are currently admitting participants."
Answered by AI
Has the FDA given their seal of approval on isatuximab SAR650984 intravenous administration?
"After taking into consideration the limited data on isatuximab SAR650984 IV, our team at Power assigned it a score of 1 for safety."
Answered by AI
Does this experiment have any open spots?
"The clinical trial's most recent update on June 5th 2022 reveals that it is not currently accepting patient applications. Although this investigation is no longer recruiting, 1,391 other trials are actively enrolling new participants."
Answered by AI
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