Isatuximab + Carfilzomib + Dexamethasone for Multiple Myeloma

(IKEMA Trial)

No longer recruiting at 162 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

Must not be taking: Antiretrovirals

Disqualifiers: Heart disease, Stroke, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 114 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of medicines for people with multiple myeloma, a type of blood cancer. The researchers aim to determine if adding isatuximab (an antibody therapy) to the standard treatment of carfilzomib and dexamethasone is more effective than the standard treatment alone. Participants should have tried 1 to 3 previous treatments for multiple myeloma and have measurable levels of the disease. This trial may suit individuals whose myeloma has relapsed or not responded well to past therapies. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of isatuximab, carfilzomib, and dexamethasone for treating multiple myeloma is generally well-tolerated. Common side effects include upper respiratory tract infections, occurring in over 20% of patients. In past studies, patients using this combination lived without disease progression for an average of 41.7 months, compared to 20.8 months for those using only carfilzomib and dexamethasone. This suggests the combination is effective and has a manageable safety profile. The FDA has approved this combination for patients with relapsed or refractory multiple myeloma, further supporting its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple myeloma?

Researchers are excited about the treatment combining Isatuximab with Carfilzomib and Dexamethasone for multiple myeloma because it introduces a new active ingredient, Isatuximab. Isatuximab is a monoclonal antibody that targets a specific protein on myeloma cells, potentially offering a more precise attack on cancer cells compared to standard treatments like Bortezomib or Lenalidomide-based therapies. Additionally, this combination therapy could enhance the effectiveness of Carfilzomib and Dexamethasone, which are already established treatments, by providing a synergistic effect that may improve patient outcomes. This approach could lead to more effective management of multiple myeloma, giving new hope to patients with this challenging condition.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

In this trial, participants will receive either the combination of isatuximab, carfilzomib, and dexamethasone or just carfilzomib and dexamethasone. Research has shown that adding isatuximab to carfilzomib and dexamethasone can significantly improve outcomes for people with multiple myeloma, a type of blood cancer. One study found that patients receiving the isatuximab combination lived without disease progression for an average of 41.7 months, nearly twice as long as the 20.8 months for those who only took carfilzomib and dexamethasone. Isatuximab targets and destroys cancer cells, aiding in better disease control. These findings suggest that the isatuximab combination is a strong option for patients who have tried other treatments. ^{3 6 7 8 9}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

This trial is for adults with multiple myeloma who've had 1-3 prior treatments. They must have measurable levels of M-protein in their blood or urine, and can't join if they're under 18, pregnant, not using birth control, previously treated with carfilzomib without response, or have certain heart conditions or severe infections.

Inclusion Criteria

I have MM, treated 1-3 times before, with measurable M-protein in my blood or urine.

Exclusion Criteria

I am under 18 years old.

You do not have the necessary medical tests completed.

I was treated with carfilzomib but didn't improve, or I finished my last therapy less than 14 days ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

Treatment

Participants receive Isatuximab, Carfilzomib, and Dexamethasone or Carfilzomib and Dexamethasone until disease progression, unacceptable adverse events, or patient decision to stop

Up to 114 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment until the analysis of overall survival

56.61 months

What Are the Treatments Tested in This Trial?

Interventions

• Carfilzomib
• Dexamethasone
• Isatuximab SAR650984

Trial Overview The study tests the effectiveness of adding isatuximab to a combination of carfilzomib and dexamethasone versus just carfilzomib and dexamethasone in patients who have undergone previous therapies for multiple myeloma.

How Is the Trial Designed?

Group I: Isatuximab + Carfilzomib + Dexamethasone (IKd) Experimental Treatment 3 Interventions

Isatuximab (intravenous) on day 1, 8, 15 and 22 of 1st cycle, then on day 1 and 15 of subsequent cycles in combination with carfilzomib (intravenous) on day 1, 2, 8, 9, 15 and 16 + dexamethasone (intravenous or by mouth \[po\]) on day 1, 2, 8, 9, 15, 16, 22 and 23 of a 28 day cycle.

Group II: Carfilzomib + Dexamethasone (Kd) Active Control 2 Interventions

Carfilzomib (intravenous) on day 1, 2, 8, 9, 15, 16 + dexamethasone (intravenous or po) on day 1, 2, 8, 9, 15, 16, 22 and 23 of a 28 day cycle.

Carfilzomib is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Kyprolis for:

• Multiple myeloma

Approved in European Union as Kyprolis for:

• Multiple myeloma

Approved in Canada as Kyprolis for:

• Multiple myeloma

Approved in Japan as Kyprolis for:

• Multiple myeloma

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

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

Citations

1. sarclisahcp.com sarclisahcp.com/ikema-efficacy

IKEMA Efficacy - SARCLISA® (isatuximab-irfc) Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma: updated results from IKEMA, a randomized phase 3 study.

2. sarclisa.com sarclisa.com/previously-treated-trial-results

for adults with previously treated multiple myeloma Patients lived progression free for a median of 41.7 months with SARCLISA + Kyprolis (carfilzomib) and dexamethasone (Kd) vs 20.8 months with Kd alone.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12030129/

Efficacy and Safety of Isatuximab, Carfilzomib, ... Conclusions: These real-world data support the use of IsaKd as a valuable option for len-R MM patients relapsing after the first-line therapy, ...

4. fda.gov fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-sarclisa-isatuximab-irfc-combination-carfilzomib-and

FDA D.I.S.C.O. Burst: Approval of Sarclisa (isatuximab-irfc) The main efficacy outcome measure was progression-free survival, assessed by an independent response committee based on central laboratory data ...

5. kyprolis-hcp.com kyprolis-hcp.com/combinations/isa-kd-efficacy

Isa-Kd Efficacy | KYPROLIS® (carfilzomib) Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma: updated results from IKEMA, a randomized Phase 3 study. Blood Cancer ...

6. fda.gov fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-multiple-myeloma

FDA approves isatuximab-irfc for multiple myeloma The most common adverse reactions (≥20%) in patients receiving isatuximab with carfilzomib and dexamethasone were upper respiratory tract ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.7526

Efficacy and safety of isatuximab subcutaneous (SC) plus ... The study met its primary endpoint, demonstrating efficacy and safety of Isa SC administration in combination with Kd, either by manual injection or OBDS.

8. sanofi.com sanofi.com/en/media-room/press-releases/2021/2021-03-31-21-15-00-2202919

FDA approves Sarclisa® (isatuximab) in combination with ... FDA approves Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma.

9. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT02332850

NCT02332850 | Phase Ib Study of SAR650984 in ... This phase Ib trial studies the side effects and best dose of isatuximab when given together with carfilzomib with or without dexamethasone and lenalidomide in ...