Clinical Trial: A Four-Drug Combination Using Isatuximab for Relapsed/Refractory Multiple Myeloma

A unique four-drug combination including isatuximab, pomalidomide, elotuzumab, and dexamethasone in the IMPEDE study is being tested for relapsed/refractory myeloma.

The study uses two monoclonal antibodies that go after two different targes (isatuximab for CD38 and elotuzumab for SLAMF7) with an immunomodulator and steroid. The study seeks to prove that adding isauximab will be safe and improve responses in relapsed myeloma.

About the Study

The main study consists of three phases:

• A 28-day screening phase
• A treatment phase that consists of 28-day cycles of isatuximab + elotuzumab + pomalidomide + dexamethasone
• A follow up phase  

This will be done in two different parts:

• Part 1: (Run-in safety phase) Six subjects will be enrolled at Medical College of Winsconsin to assess potential toxicities that may be associated with certain doses.
• Part 2: (Expansion phase) Up to 47 subjects will be enrolled.

The study will evaluate response to treatment according to the International Myeloma Working Group’s criteria:

• Stringent complete response
• Complete response
• Very good partial response
• Partial response 
• Minimal response 
• Stable disease 
• Progressive disease 

For years 1-3, the number of patients in each response category will be noted at the end of each year. 

Patients can join if they have already received 2 prior myeloma therapies that include lenalidomide with a proteasome inhibitor and their myeloma is progressing on their current myeloma treatment. 

For more information about the inclusion/exclusion criteria, click here.

The study is open at Froedtert Hospital & the Medical College of Wisconsin in Milwaukee. 

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