Isatuximab + VRd for Multiple Myeloma
(IMROZ Trial)

Recruiting in Palo Alto (17 mi)

+312 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sanofi

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called isatuximab added to a standard treatment mix. It targets patients with newly diagnosed multiple myeloma who can't have a transplant. Isatuximab helps the immune system destroy cancer cells, while the other drugs kill cancer cells and reduce inflammation.

Eligibility Criteria

This trial is for adults with newly diagnosed multiple myeloma who can't have a transplant because they're over 65 or under 65 with other health issues. They must have measurable disease signs and agree to use contraception if necessary. It's not for those under 18, previously treated for myeloma, or with certain health conditions that could interfere.

Inclusion Criteria

I have been diagnosed with multiple myeloma.

I am over 65 or have health issues that prevent a bone marrow transplant for my newly diagnosed multiple myeloma.

I have been diagnosed with multiple myeloma.

+5 more

Exclusion Criteria

My organ functions are not within the required range.

I am a male and agree to follow contraceptive advice during the study.

I am under 18 years old.

+5 more

Participant Groups

The study tests whether adding Isatuximab (SAR650984) to the combo of Bortezomib, Lenalidomide, and Dexamethasone improves survival without cancer progression in new multiple myeloma patients ineligible for transplant compared to just the three-drug combo.

3Treatment groups

Experimental Treatment

Active Control

Group I: Isatuximab/Lenalidomide/Dexamethasone = IRd crossover armExperimental Treatment3 Interventions

4-weeks cycles with IV isatuximab + oral lenalidomide + IV or oral dexamethasone

Group II: Isatuximab/Bortezomib/Lenalidomide/Dexamethasone = IVRd armExperimental Treatment4 Interventions

1. Induction treatment with 4x6-week cycles with intravenous (IV) isatuximab + subcutaneous (SC) bortezomib + oral lenalidomide + IV or oral dexamethasone 2. Continuous treatment with 4-week cycles with IV isatuximab + oral lenalidomide + IV or oral dexamethasone

Group III: Bortezomib/Lenalidomide/Dexamethasone = VRd armActive Control3 Interventions

1. Induction treatment with 4x6-week cycles with SC bortezomib + oral lenalidomide + IV or oral dexamethasone 2. Continuous treatment with 4-week cycles with oral lenalidomide + IV or oral dexamethasone

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

🇪🇺 Approved in European Union as Velcade for: