A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma

Phase 3

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: Iberdomide; Drug: Lenalidomide

• Registration Number: NCT05827016
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-04-11
• Study First Posted: 2023-04-24
• Study Start: 2023-06-22
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-27
• Last Update Posted: 2025-07-01
• Primary Completion: 2029-03-15
• Study Completion: 2036-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1216

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A2: Iberdomide Dose 2	Iberdomide	-
Arm A3: Iberdomide Dose 3	Iberdomide	-
Arm B: Lenalidomide	Lenalidomide	-
Arm A1: Iberdomide Dose 1	Iberdomide	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Up to 6 years

Secondary Outcome Measures

Name	Time	Method
Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (± 3) months of maintenance treatment	Up to 6 years
Area under the iberdomide plasma concentration-time curve from time zero to tau	Up to 1 year
Area under the iberdomide plasma concentration-time curve within a dosing interval AUC (TAU)	Up to 1 year
Achieving MRD negativity in participants with CR or better at any time after the date of randomization	Up to 6 years
Overall Survival	Up to 12 years
Time to maximum iberdomide plasma concentration (Tmax)	Up to 1 year
Recommended iberdomide dose for Stage 2	Up to 1 year
Number of participants with adverse events (AEs)	Up to 6 years
Progression-free survival on next line of treatment (PFS2)	Up to 6 years
Conversion from MRD positive to MRD negative in participants with CR or better	Up to 6 years
Time to progression (TTP)	Up to 6 years
Time to next treatment (TTNT)	Up to 6 years
Best response achieved prior to progressive disease (PD)	Up to 6 years
Patient-reported health-related quality of life (HRQoL) outcomes and multiple myeloma-related symptoms as measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life C30 questionnaire (QLQ-C30)	Up to 6 years
Patient-reported HRQoL outcomes and multiple myeloma-related symptoms as measured by the EORTC Quality of Life Multiple Myeloma Module (QLQ-MY20)	Up to 6 years
Maximum iberdomide concentration (Cmax)	Up to 1 year
Achievement of CR or better and maintaining MRD-negative status in 2 bone marrow aspirate assessments that are a minimum of 1 year apart, without any examination showing MRD positive status in between assessments	Up to 6 years

Trial Locations

Locations (280)

Rocky Mountain Cancer Centers; 🇺🇸 Aurora, Colorado, United States

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

H. Lee Moffitt Cancer Center & Research Institute; 🇺🇸 Tampa, Florida, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University Cancer Blood Ctr; 🇺🇸 Athens, Georgia, United States

The Winship Cancer Institute of Emory University; 🇺🇸 Atlanta, Georgia, United States

Augusta University - Georgia Cancer Center; 🇺🇸 Augusta, Georgia, United States

The University of Chicago Medical Center - Duchossois Center for Advanced Medicine; 🇺🇸 Chicago, Illinois, United States

University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion; 🇺🇸 Westwood, Kansas, United States

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