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

A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230223

Enrollment

1216

Registered

2023-07-13

Start date

2023-07-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Interventions

Arm A1: Iberdomide Dose 1 Arm A2: Iberdomide Dose 2 Arm A3: Iberdomide Dose 3 Arm B: Lenalidomide Specified dose on specified days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Confirmed diagnosis of symptomatic multiple myeloma (MM) - Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2 - Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) [eg, bortezomib thalidomide and dexamethasone (VTd), lenalidomide, bortezomib and dexamethasone (RVd)] with or without a CD38 monoclonal antibody, or bortezomib, cyclophosphamide, dexamethasone (VCd), and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted - Participants within 12 months from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation, according to International Myeloma Working Group (IMWG 2016) criteria

Exclusion criteria

Exclusion criteria: - Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy - Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma - Known central nervous system/meningeal involvement of MM - Prior history of malignancies, other than MM, unless the participant has been free of the disease for >= 5 years

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) [ Time Frame: Up to 6 years ]	—

Secondary

Measure	Time frame
1. Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (+- 3) months of maintenance treatment [ Time Frame: Up to 6 years ] 2. Overall Survival [ Time Frame: Up to 12 years ] 3. Recommended iberdomide dose for Stage 2 [ Time Frame: Up to 1 year ] 4. Area under the iberdomide plasma concentration-time curve from time zero to tau [ Time Frame: Up to 1 year ] 5. Area under the iberdomide plasma concentration-time curve within a dosing interval AUC (TAU) [ Time Frame: Up to 1 year ] 6. Maximum iberdomide concentration (Cmax) [ Time Frame: Up to 1 year ] 7. Time to maximum iberdomide plasma concentration (Tmax) [ Time Frame: Up to 1 year ] 8. Number of participants with adverse events (AEs) [ Time Frame: Up to 6 years ] 9.Progression-free survival on next line of treatment (PFS2) [ Time Frame: Up to 6 years ] 10.Achieving MRD negativity in participants with CR or better at any time after the date of randomization [ Time Frame: Up to 6 years ] 11. Conversion from MRD positive to MRD negative in participants with CR or better [ Time Frame: Up to 6 years ] 12. Achievement of CR or better and maintaining MRD-negative status in 2 bone marrow aspirate assessments that are a minimum of 6 months or 1 year apart, without any examination showing MRD positive status in between assessments [ Time Frame: Up to 6 years ] 13. Time to progression (TTP) [ Time Frame: Up to 6 years ] 14. Time to next treatment (TTNT) [ Time Frame: Up to 6 years ] 15. Best response achieved prior to progressive disease (PD) [ Time Frame: Up to 6 years ] 16. 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) [ Time Frame: Up to 6 years ] 17. Patient-reported HRQoL outcomes and multiple myeloma-related symptoms as measured by the EORTC Quality of Life Multiple Myeloma Mo	—

Measure

Time frame

1. Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (+- 3) months of maintenance treatment [ Time Frame: Up to 6 years ] 2. Overall Survival [ Time Frame: Up to 12 years ] 3. Recommended iberdomide dose for Stage 2 [ Time Frame: Up to 1 year ] 4. Area under the iberdomide plasma concentration-time curve from time zero to tau [ Time Frame: Up to 1 year ] 5. Area under the iberdomide plasma concentration-time curve within a dosing interval AUC (TAU) [ Time Frame: Up to 1 year ] 6. Maximum iberdomide concentration (Cmax) [ Time Frame: Up to 1 year ] 7. Time to maximum iberdomide plasma concentration (Tmax) [ Time Frame: Up to 1 year ] 8. Number of participants with adverse events (AEs) [ Time Frame: Up to 6 years ] 9.Progression-free survival on next line of treatment (PFS2) [ Time Frame: Up to 6 years ] 10.Achieving MRD negativity in participants with CR or better at any time after the date of randomization [ Time Frame: Up to 6 years ] 11. Conversion from MRD positive to MRD negative in participants with CR or better [ Time Frame: Up to 6 years ] 12. Achievement of CR or better and maintaining MRD-negative status in 2 bone marrow aspirate assessments that are a minimum of 6 months or 1 year apart, without any examination showing MRD positive status in between assessments [ Time Frame: Up to 6 years ] 13. Time to progression (TTP) [ Time Frame: Up to 6 years ] 14. Time to next treatment (TTNT) [ Time Frame: Up to 6 years ] 15. Best response achieved prior to progressive disease (PD) [ Time Frame: Up to 6 years ] 16. 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) [ Time Frame: Up to 6 years ] 17. Patient-reported HRQoL outcomes and multiple myeloma-related symptoms as measured by the EORTC Quality of Life Multiple Myeloma Mo

—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Other 5 countries, Poland, Portugal, Romania, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States

Contacts

Public ContactJorge Acosta

Bristol-Myers Squibb

MG-JP-RCO-JRCT@bms.com+81-120-093-507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026