NCT05434689

COMbination Regimens in MM Post AHCT to elimiNate MRD Utilizing IbERdomide

Phase Ib/II Trial Of Iberdomide-Combinations In Patients With Positive Minimal Residual Disease (>10-5) After Autologous Hematopoietic Cell Transplantation In The Upfront Management Of Patients With Multiple Myeloma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Similar to the paradigm established in other hematologic malignancies that are considered curable, the achievement of MRD(-) status is necessary for long term disease control in MM. The fact that the majority of patients remain MRD (+) after induction therapy and AHCT points to the opportunity to deploy novel agents with complementary mechanism of action and favorable toxicity profile to reach and maintain MRD (-) status. Given its favorable toxicity profile, the convenience of oral administration, and compelling single agent activity even in heavily pretreated MM, iberdomide is likely amenable to long term therapy in patients with high-risk of relapse/progression identified by the persistence of MRD(+). The investigators intend to develop combination(s) of iberdomide with other agents with complementary mechanism of action in the consolidation setting post AHCT in order to achieve and sustain MRD (-).

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Iberdomide	Iberdomide (Iber, CC-220) is a novel cereblon E3 ligase modulator (CELMoD) in development for treatment of multiple myeloma and other conditions.
DRUG	Daratumumab	Anti-CD 38 monoclonal antibody established in the treatment of multiple myeloma
DRUG	Dexamethasone	Corticosteroid active against multiple myeloma in combination with other agents
DRUG	Carfilzomib	Second generation proteasome inhibitor with activity in multiple myeloma

Timeline

• Start date: 2023-01-18
• Primary completion: 2026-04-01
• Completion: 2026-10-01
• First posted: 2022-06-28
• Last updated: 2026-04-15

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study