NCT04835129

Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

A Multisite, Phase II Study of Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label phase II study in subjects with relapsed and/or refractory multiple myeloma with at least two prior lines of therapy. The main study consists of three phases: a 28-day screening phase, treatment phase that consists of 28-day cycles of isatuximab with elotuzumab, pomalidomide, and dexamethasone and a follow-up phase.

Detailed description

The study is divided into two parts: Part 1 (Run-in safety phase): In this safety-run in phase a total of six subjects will be enrolled at the coordinating site (Medical College of Wisconsin) to assess potential dose-limiting toxicities that may be associated with the addition of isatuximab with pomalidomide, elotuzumab and dexamethasone. Part 2 (Expansion phase): In this part, up to 47 additional subjects will be enrolled. The study hypothesis is that the isatuximab in combination with elotuzumab, pomalidomide, and dexamethasone (Isa-EPD) will be safe and lead to superior response rates than seen with either isatuximab with pomalidomide and dexamethasone or elotuzumab with pomalidomide and dexamethasone in subjects with relapsed and/or refractory multiple myeloma.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Isatuximab (for run-in portion)	10 mg/kg IV on days 2, 8, 15, 22 of cycle 2 and days 1 and 15 of subsequent cycles.
DRUG	Isatuximab (for expansion)	10 mg/kg IV on days 2, 8, 15, 22 of cycle 1 and days 1 and 15 of subsequent cycles.
DRUG	Pomalidomide	4 mg PO days 1-21 of each cycle.
DRUG	Elotuzumab	10 mg/kg on days 1, 8, 15, 22 of cycles 1 and 2; 20 mg/kg on day 1 of subsequent cycles.
DRUG	Dexamethasone	40 mg (20 mg if \>75 years) PO or IV on days 1, 8,15 and 22 of each cycle.

Timeline

• Start date: 2022-01-10
• Primary completion: 2027-04-01
• Completion: 2027-06-01
• First posted: 2021-04-08
• Last updated: 2026-03-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study