Isatuximab + Iberdomide + Bortezomib + Dexamethasone for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of drugs to identify the best treatment for individuals with newly diagnosed multiple myeloma, a type of blood cancer. Participants will receive drugs such as isatuximab, iberdomide, bortezomib, and dexamethasone to evaluate the cancer's response. The trial will also explore different treatment strategies based on the cancer's aggressiveness and its reaction to initial treatments. Individuals with multiple myeloma, exhibiting signs like bone damage or kidney issues caused by the disease, may qualify to join. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants early access to potentially effective treatments.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get specific guidance based on your situation.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that patients generally tolerate the combination of isatuximab and iberdomide well. A safety review of 477 participants found isatuximab to be safe. Although some patients developed infections, doctors monitored them closely. Studies also demonstrated iberdomide's safety, even for those unresponsive to treatments like Revlimid.
For linvoseltamab, studies indicate safety for patients with multiple myeloma. While certain studies reported treatment-related deaths, the treatment was overall considered safe and effective.
These findings suggest that the treatments under study have shown acceptable safety in previous research, though monitoring for side effects like infections remains important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Isatuximab, Iberdomide, and Bortezomib for treating multiple myeloma because it offers a fresh approach to battling the condition. Unlike the standard care options like lenalidomide and bortezomib, this treatment combines a monoclonal antibody (Isatuximab) with an innovative cereblon E3 ligase modulator (Iberdomide), potentially enhancing the immune response against cancer cells. Additionally, Isatuximab targets a specific protein, CD38, on the surface of myeloma cells, which may improve the treatment's precision and effectiveness. By integrating these unique mechanisms, this combination could offer improved outcomes for patients compared to existing therapies.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
Research has shown that combining isatuximab and iberdomide may effectively treat multiple myeloma, a type of blood cancer. In this trial, some participants will receive isatuximab and iberdomide as part of their treatment regimen. Previous studies found that patients who received isatuximab, iberdomide, and dexamethasone had fewer cancer cells remaining in their bodies. Studies also suggest that this combination can significantly reduce the risk of disease progression or death. Additionally, when used alone, iberdomide has led to a reduction in cancer symptoms for many patients. These findings support the potential effectiveness of this combination in fighting multiple myeloma.36789
Who Is on the Research Team?
Clifton C. Mo, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for adults with newly diagnosed multiple myeloma who are healthy enough to undergo a stem cell transplant. Participants should not have received prior treatment for their myeloma and must meet certain health requirements set by the study team.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive induction treatment with isatuximab, iberdomide, bortezomib, and dexamethasone for 8 cycles
Consolidation
Participants with high-risk disease or MRD-positive results receive consolidation with high-dose melphalan followed by autologous stem cell transplant or linvoseltamab
Maintenance
Participants receive maintenance therapy with isatuximab and iberdomide for up to 36 cycles, adapted based on MRD status
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bortezomib
- Dexamethasone
- Iberdomide
- Isatuximab
Trial Overview
The study tests a combination of four drugs (isatuximab, iberdomide, bortezomib, dexamethasone) as initial treatment. After this phase, further treatments are adjusted based on each person's risk level and how well they respond. The goal is to find the best approach for different patient groups.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Active Control
Participants in Cohort 2 who do not meet criteria for consolidation therapy may enter Arm G. Standard Risk (SR) MRD-indeterminate participants may also enter Arm G or, with Sponsor-Investigator approval, may be randomized in Cohort 2. Arm G is a 3-drug maintenance regimen continued in 28-day cycles until progression. The protocol explicitly states that dexamethasone is excluded from Arm G.
Eligible Cohort 2 participants are randomized to Arm F: linvoseltamab consolidation for 8 cycles followed by isatuximab + iberdomide maintenance until progression. The protocol explicitly identifies Arm F as the experimental arm and hypothesizes superior efficacy versus Arm E. Maintenance should begin within 2-4 weeks after the last linvoseltamab dose.
After completion of Arm B, participants with MRD-positive or MRD-indeterminate disease, or \<VGPR (very good partial response) at Step 3 evaluation \[unless Progressive Disease (PD)\], continue iberdomide + isatuximab until progression.
After completion of Arm B, participants with MRD-negative Complete Response (CR) status at Step 3 are assigned to Arm C and continue single-agent iberdomide until progression. Isatuximab is not administered in Arm C.
Participants assigned to Cohort 1 enter Arm B and receive isatuximab + iberdomide maintenance for 36 cycles. Maintenance should begin within 28 days of the last induction cycle.
All enrolled participants begin with Step 1 induction that consists of eight 28-day cycles before end-of-induction cohort assignment. Peripheral Blood Stem Cells (PBSC) mobilization/collection is planned after completion of 4-6 cycles of induction for participants without disease progression. End-of-induction MRD/response and cytogenetic risk status determine whether participants proceed to post-induction Cohort 1 or Cohort 2.
Eligible Cohort 2 participants are randomized to Arm E: High-Dose Melphalan followed by Autologous Stem Cell Transplantation (HDM-ASCT) consolidation followed by isatuximab + iberdomide maintenance until progression. The protocol identifies Arm E as the control arm and describes HDM-ASCT-based therapy as the SOC comparator for Cohort 2. Consolidation should begin preferably within 30 days, and no later than 42 days, after induction completion. Maintenance begins 60-110 days after PBSC infusion.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Sanofi
Industry Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University
Celgene Corporation
Industry Sponsor
Mark Alles
Celgene Corporation
Chief Executive Officer since 2016
Bachelor's degree from Lock Haven University of Pennsylvania
Sol J. Barer
Celgene Corporation
Chief Medical Officer since 2006
PhD in Organic and Physical Chemistry from Rutgers University
Regeneron Pharmaceuticals
Industry Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Citations
1.
onclive.com
onclive.com/view/iberdomide-daratumumab-dexamethasone-is-effective-in-newly-diagnosed-multiple-myelomaIberdomide/Daratumumab/Dexamethasone Is Effective in ...
The iberdomide-daratumumab-dexamethasone regimen achieved a 93.1% overall response rate in frail, transplant-ineligible multiple myeloma ...
Iberdomide
With a median follow-up of 14 months, the 12-month overall survival (OS) was 86%, the 12-month duration of response (DoR) was 76%, and the 12-month progression- ...
EXCALIBER-RRMM: a phase III trial of iberdomide ... - PMC
Background. Iberdomide in combination with daratumumab and dexamethasone demonstrated promising preliminary efficacy and was well tolerated in a phase I/II ...
4.
cancernetwork.com
cancernetwork.com/view/will-the-fda-approve-iberdomide-in-relapsed-refractory-multiple-myeloma-Will the FDA Approve Iberdomide in Relapsed/Refractory ...
If approved, iberdomide plus daratumumab/dexamethasone would offer patients more choices, according to Sagar Lonial, MD, FACP, FASCO.
NCT04975997 | Open-label Study Comparing Iberdomide ...
To evaluate clinical efficacy in terms of overall survival (OS) in participants with relapsed or refractory multiple myeloma (RRMM) treated with iberdomide, ...
Efficacy and safety of isatuximab monotherapy to treat ... - PMC
The safety analysis, which included 477 participants from four clinical trials, showed that isatuximab had an acceptable safety profile that was ...
SARCLISA® (isatuximab-irfc) | IKEMA Safety
Explore the safety information for SARCLISA + carfilzomib and dexamethasone (Kd) in the IKEMA trial. See Important Safety & Prescribing Info.
About Multiple Myeloma
Infections. SARCLISA can cause infections that are severe, life-threatening, or that may lead to death. Your healthcare provider will monitor you for signs and ...
9.
news.sanofi.us
news.sanofi.us/2020-03-02-FDA-approves-Sarclisa-R-isatuximab-irfc-for-patients-with-relapsed-refractory-multiple-myelomaFDA approves Sarclisa® (isatuximab-irfc) for patients with ...
FDA approves Sarclisa® (isatuximab-irfc) for patients with relapsed refractory multiple myeloma. * ... Sarclisa Safety Profile and Efficacy ...
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