NCT05199311

Carfilzomib, Iberdomide (CC-220) and Dexamethasone (KID) in Transplant Eligible Multiple Myeloma

A Phase I/II Study of Carfilzomib, Iberdomide (CC-220) and Dexamethasone (KID) in Patients With Newly Diagnosed Transplant Eligible Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Hackensack Meridian Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-institution, open label, phase I/II study of Iberdomide, Carfilzomib, and dexamethasone (KID) in patients with newly diagnosed transplant eligible MM.

Detailed description

This is a multi-institution, open label, phase I/II study of Iberdomide, Carfilzomib, and dexamethasone (KID) in patients with newly diagnosed transplant eligible MM. As part of a dose escalation phase, the first 10 patients will be enrolled at dose level -1 (Iberdomide 1.1 mg po daily days 1-21). Two months after the first 10 patients have completed at least 2 cycles of therapy in dose level -1, an Independent Safety Review Committee will review the safety data. Assuming the combination is determined to have adequate safety and tolerability, 10 patients will be enrolled at dose level 1 (Iberdomide 1.3 mg po daily days 1-21). After an independent safety review two months after 10 patients have completed at least 2 cycles of therapy in dose level 1, the remaining 46 patients will be enrolled at dose level 2 (Iberdomide 1.6 mg po daily days 1-21). Treatment will continue for up to 4 cycles (28 days) at the physician's discretion followed by the Autologous Stem Cell Transplant. Patients will be followed every 3 months for up to 2 years, or until disease progression or the start of a new line of therapy.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Carfilzomib	20 mg/m2 C1D1; 56 mg/m2 thereafter
DRUG	Iberdomide	Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle
DRUG	Oral Dexamethasone	40 mg (\<=75 years old); 20 mg (\>75 years old)

Timeline

• Start date: 2022-05-13
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2022-01-20
• Last updated: 2026-02-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study