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RecruitingLast updated: 15 February 2024

EXCALIBER-Maintenance: This study is comparing the effectiveness of two different drugs as maintenance therapy after autologous stem cell transplantation in people with newly diagnosed multiple myelomaA 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)

Clinical summary

Summary

This study is comapring the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in people with newly diagnosed multiple myeloma.

Eligible participants will be randomly allocated to one of four treatment arms.

  • Arm A1 (Experimental) will receive Iberdomide Dose 1
  • Arm A2 (Experimental) will receive Iberdomide Dose 2
  • Arm A3 (Experimental) will receive Iberdomide Dose 3
  • Arm B (Active Comparator) willr eceive Lenalidomide

 

Conditions

This trial is treating patients with newly diagnosed multiple myeloma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

EXCALIBER-Maintenance

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb

Scientific Title

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)

Eligibility

Inclusion

  • 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 Velcade® (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

  • 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.

Inclusion

  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

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