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Monoclonal Antibodies
Isatuximab Combination Therapy for Multiple Myeloma
Phase 1 & 2
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
RRMM with measurable disease: Serum M protein ≥0.5 g/dL, Urine M protein ≥200 mg/24 hours, or Serum free light chain (sFLC) MM without measurable M protein in serum or urine per previous criteria
Substudy 04: Participants must be exposed to anti-CD38 and anti-BCMA therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up continuous throughout study assessment (up to approximately 28 months)
Awards & highlights
Study Summary
This trial is testing the combination of isatuximab with either pomalidomide or lenalidomide in patients with RRMM. The primary objectives are to determine the recommended dose of the novel agents and to demonstrate the clinical benefit of the combination therapy. Secondary objectives include assessing safety and tolerability, progression free survival, and overall survival.
Who is the study for?
Adults with relapsed or refractory multiple myeloma who've had at least 3 prior treatments, including proteasome inhibitors and immunomodulatory drugs, or 2 lines of multiagent regimens. They must have measurable disease levels and be able to use contraception. Those previously treated with anti-CD38 therapy can join if it's been over 6 months since the last dose.Check my eligibility
What is being tested?
The trial is testing isatuximab combined with new agents like Belumosudil and others, some in controlled experiments. It aims to see how well these combinations work for those whose myeloma has returned after treatment or hasn't responded to standard therapies.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as infusion-related symptoms, blood disorders, increased risk of infections, fatigue, digestive issues due to dexamethasone and other novel agents used alongside Isatuximab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My multiple myeloma is measurable by specific protein levels in my blood or urine.
Select...
I have been treated with anti-CD38 and anti-BCMA therapies.
Select...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ continuous throughout study assessment (up to approximately 28 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~continuous throughout study assessment (up to approximately 28 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 (dose finding, experimental substudies): Determination of recommended dose of novel agents in combination with isatuximab
Part 2 (expansion, controlled experimental substudies): VGPR Rate (Rate of Very Good Partial Response Rate or Better)
Part 2 (expansion, independent experimental substudies): Overall Response Rate (ORR) in independent experimental substudies
Secondary outcome measures
Assessment of Health care resource utilization related with SREs for control and experimental arms (Substudy 02)
Clinical benefit rate (CBR) in each treatment arm
Disease- and treatment-related quality of life will be assessed using the EORTC multiple myeloma module (QLQ-MY20) questionnaire
+19 moreTrial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: isatuximab + dexamethasone + belantamab mafodotin (Substudy 03)Experimental Treatment3 Interventions
Belantamab mafodotin in combination with isatuximab and dexamethasone
Part 1:
1 DL of IV belantamab mafodotin in Part 1 and de-escalation dose DL-1:
DL1 belantamab mafodotin IV dose QW4 or de-escalation dose DL-1 QW8
Isatuximab dose, IV QW × 4 weeks (Cycle 1), followed by Q2W (subsequent cycles).
Dexamethasone fixed dose and schedule: QW by mouth.
Part 2:
Isatuximab IV dose QW × 4 weeks (Cycle 1), followed by Q2W (subsequent cycles).
Belantamab mafodotin IV dose Q4W or Q8W
Dexamethasone fixed dose and schedule: QW by mouth.
Group II: isatuximab + SAR439459 + dexamethasone (Substudy 02)Experimental Treatment3 Interventions
SAR439459 in combination with isatuximab and dexamethasone
Part 1:
2 dose levels (DLs) of IV SAR439459:
DL1 SAR439459 dose Q2W.
DL2 SAR439459 dose Q2W.
Isatuximab dose IV QW × 5 weeks (Cycle 1), followed by Q2W administrations (subsequent cycles).
Dexamethasone fixed dose and schedule: QW by mouth In Cycle 1, the first administration of SAR439459 (Day 1) will precede isatuximab by 1 week (first dose of isatuximab will be at Cycle 1 Day 8).
Part 2:
SAR439459 IV dose Q2W.
Isatuximab IV dose QW × 5 weeks (Cycle 1), followed by Q2W administrations (subsequent cycles).
Dexamethasone fixed dose and schedule: QW by mouth. In Cycle 1, the first administration of SAR439459 (Day 1) will precede isatuximab by 1 week (first dose of isatuximab will be at Cycle 1 Day 8).
Group III: Isatuximab + pegenzileukin (Substudy 04)Experimental Treatment2 Interventions
Pegenzileukin in combination with isatuximab
Part 1- dose escalation:
Up to 3 DLs of IV pegenzileukin are planned to be evaluated:
DL1 will explore pegenzileukin at Q2W.
DL2 will explore pegenzileukin at Q2W.
DL3 will explore pegenzileukin at Q2W.
Isatuximab IV dose QW × 4 weeks, followed by Q2W (subsequent cycles).
Part 1 - dose optimization:
Isatuximab IV doseQW × 4 weeks, followed by Q2W (subsequent cycles).
Pegenzileukin at potential doses (DL A and DL B) Q2W.
Part 2 (dose expansion):
Isatuximab IV dose QW × 4 weeks, followed by Q2W (subsequent cycles).
Pegenzileukin IV dose Q2W.
Group IV: Isatuximab + evorpacept + dexamethasone (Substudy 06)Experimental Treatment3 Interventions
Isatuximab in combination with evorpacept and dexamethasone
Part 1- dose escalation:
Evorpacept IV dose Q2W
Isatuximab IV dose QW × 4 weeks, followed by Q2W (subsequent cycles)
Dexamethasone fixed dose and schedule: QW by mouth Part 1- dose optimization
Evorpacept IV at potential doses (DL A and DL B), Q2W
Isatuximab IV dose QW × 4 weeks, followed by Q2W (subsequent cycles)
Dexamethasone fixed dose and schedule: QW by mouth
Part 2- dose expansion:
Evorpacept IV dose Q2W
Isatuximab IV dose QW × 4 weeks, followed by Q2W (subsequent cycles)
Dexamethasone fixed dose and schedule: QW by mouth
Group V: Experimental: Isatuximab + Dexamethasone + Belumosudil (Substudy 05)Experimental Treatment3 Interventions
Isatuximab in combination with belumosudil and dexamethasone Part 1- dose escalation: During the first cycle, belumosudil will be evaluated in monotherapy during 2 to 4 weeks, then isatuximab and dexamethasone will be added, and continued for the subsequent cycles.
Belumosudil by mouth at Dose Level (DL) 1, DL2, DL3, and DL4
Isatuximab IV dose QW × 4 weeks, followed by Q2W (subsequent cycles)
Dexamethasone fixed dose and schedule: QW by mouth
Part 1- dose optimization:
Belumosudil at potential doses (DL A and DL B), daily by mouth
Isatuximab IV dose QW × 4 weeks, followed by Q2W (subsequent cycles)
Dexamethasone fixed dose and schedule: QW by mouth
Part 2- dose expansion:
Belumosudil dose daily, by mouth
Isatuximab IV dose QW × 4 weeks, followed by Q2W (subsequent cycles)
Dexamethasone fixed dose and schedule: QW by mouth
Group VI: Control Arm: isatuximab + pomalidomide + dexamethasone (Substudy 01)Active Control3 Interventions
Isatuximab, intravenous (IV) doseweekly (QW) × 4 weeks (Cycle 1), followed by every two weeks (Q2W) (subsequent cycles).
Pomalidomide dose by mouth daily Day 1 to Day 21.
Dexamethasone dose by mouth QW.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belantamab mafodotin
2019
Completed Phase 1
~10
Belumosudil
2018
Completed Phase 2
~320
Isatuximab
2016
Completed Phase 3
~370
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,283 Total Patients Enrolled
47 Trials studying Multiple Myeloma
10,004 Patients Enrolled for Multiple Myeloma
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,019,102 Total Patients Enrolled
22 Trials studying Multiple Myeloma
4,006 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any medication for multiple myeloma, including dexamethasone, in the last 14 days.Your platelet count is less than 50,000 per microliter.I have a condition that affects how my body absorbs medication.I have not had an uncontrolled infection in the last 14 days.You have an ongoing hepatitis C virus infection.Your kidneys are not working well enough, with a creatinine clearance less than 30 mL/min.I have an active or uncontrolled hepatitis B infection.I have been cancer-free from a second cancer, other than minor skin cancers, for over 3 years.I have severe hypercalcemia.I haven't had severe stomach or bowel issues in the last 3 months.I haven't had serious heart or blood vessel problems in the last 3 months.You have had certain types of skin or cervical cancer in the past, or have taken certain blood-thinning medications recently, or have abnormal blood clotting test results.My multiple myeloma is measurable by specific protein levels in my blood or urine.I have been treated with anti-CD38 and anti-BCMA therapies.I have not received a live vaccine within the last 4 weeks.Your body has too few infection-fighting white blood cells.I have a mild eye condition but haven't had belantamab mafodotin treatment.I have brain or spinal cord disease, a history of seizures, or I'm on certain drugs that need close monitoring.I have had at least 3 treatments for my multiple myeloma, including specific types.I have been diagnosed with a specific blood or bone marrow condition.Your liver enzymes are more than three times the normal level.Your hemoglobin level is less than 8 grams per deciliter.I am 18 years old or older.I am fully active or can carry out light work.I agree to use birth control during the study.I do not have AIDS, HIV needing treatment, or active hepatitis A.Your bilirubin level is too high, unless you have a condition called Gilbert syndrome, in which case a different bilirubin level is used to measure.I have not had, or it's been 6 months since my last anti-CD38 therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Isatuximab + pegenzileukin (Substudy 04)
- Group 2: Experimental: Isatuximab + Dexamethasone + Belumosudil (Substudy 05)
- Group 3: isatuximab + dexamethasone + belantamab mafodotin (Substudy 03)
- Group 4: Control Arm: isatuximab + pomalidomide + dexamethasone (Substudy 01)
- Group 5: isatuximab + SAR439459 + dexamethasone (Substudy 02)
- Group 6: Isatuximab + evorpacept + dexamethasone (Substudy 06)
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.
What other research efforts have been undertaken to explore the use of Dexamethasone?
"Back in 2002, the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba were among the first to study dexamethasone. Since then, 1141 studies have been completed and there are now 601 clinical trials actively recruiting patients - many of which are located in Ann Arbor, Michigan."
Answered by AI
How many sites are hosting this clinical trial?
"This medical trial is dispersing across the United States and includes centres such as University of Illinois-Site Number:8400007 in Ann Arbor, Michigan; University of Michigan-Site Number:8400004 in Buffalo, New york; Roswell Park Cancer Institute-Site Number:8400008 in Birmingham, Alabama amongst other locales."
Answered by AI
How is Dexamethasone commonly utilized to treat medical conditions?
"Dexamethasone is a common treatment for ophthalmia, sympathetic and can also be utilized to address branch retinal vein occlusion, macular edema, or communicable diseases."
Answered by AI
Are there any open vacancies remaining in this clinical experiment?
"According to the clinicaltrials.gov listing, this medical study is actively recruiting and was first posted on January 25th 2021 with an update made October 17th 2022."
Answered by AI
What is the enrolment capacity for this experiment?
"Sanofi, the sponsor of this trial, require a total of 72 participants with pre-defined inclusion criteria to conduct it. Two sites have been chosen for the study: University of Illinois (Ann Arbor, Michigan) and University of Michigan (Buffalo, New york)."
Answered by AI
What positive results is this trial expected to produce?
"The trial's primary outcome, which is measured over a 6 week period, focuses on the Very Good Partial Response Rate of participants in experimental substudies. Secondary assessments include evaluations of health care resource utilization related to SREs for both control and experimental arms via HCRU-SREs questionnaire; time to first occurrence of SRE assessment between the two arms; and Time To Best Response (TTBR) in each arm from date of randomization to date of best overall response confirmation."
Answered by AI
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