Isatuximab + Carfilzomib + Dexamethasone for Multiple Myeloma

(IKEMA Trial)

Recruiting at 140 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

302 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study it to compare the efficacity of isatuximab when combined to carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with multiple myeloma already treated with 1 to 3 prior lines of therapy.

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