Home › Trials › NCT05827016

Comparing iberdomide and lenalidomide maintenance after stem cell transplant for 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)

Phase 3 Interventional Bristol-Myers Squibb · NCT05827016

This study is testing whether iberdomide works better than lenalidomide as a follow-up treatment for people with multiple myeloma after they have had a stem cell transplant.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1216 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionsdaratumumab, cyclophosphamide
Locations285 sites (Aurora, Colorado and 284 other locations)
Trial IDNCT05827016 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of iberdomide maintenance therapy compared to lenalidomide maintenance therapy in patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Participants will have received prior induction therapy and must have achieved at least a partial response after their transplant. The study is designed as a Phase 3 interventional trial to determine which maintenance therapy provides better outcomes for patients.

Who should consider this trial

Good fit: Ideal candidates include individuals with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation and achieved at least a partial response.

Not a fit: Patients who have not received prior induction therapy or those who do not meet the response criteria after transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved maintenance therapy options for patients with multiple myeloma, potentially enhancing their long-term outcomes.

How similar studies have performed: Other studies have shown promising results with similar maintenance therapies in multiple myeloma, suggesting that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion 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, daratumumab + bortezomib/thalidomide/dexamethasone \[D-VTd\] and daratumumab + bortezomib/ lenalidomide/dexamethasone \[D-VRd\]), or VCd / daratumumab + bortezomib/cyclophosphamide/dexamethasone \[D-VCd\], and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted.
* Participants within 12 months (single transplant) or 15 months (tandem transplant) 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

* 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.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where this trial is running

Aurora, Colorado and 284 other locations

+235 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple MyelomaIberdomideCC-220LenalidomideMMNDMMMaintenanceAutologous stem cell transplant
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.