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Recruiting

A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma - IM048-022

Oppdatert: 9 april, 2024   |   ClinicalTrials.gov

Utskriftsvennlig Sammendrag

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Vis detaljer

  • Phase 3

    Fase

  • Kjønn

  • 18+

    Aldersgruppe

  • 116

    Sted(er)

  • Recruiting

Behandlingsalternativer

Studiearmer
TILDELT INTERVENSJON
Experimental: Arm A1: Iberdomide Dose 1
Drug: Iberdomide
Experimental: Arm A2: Iberdomide Dose 2
Drug: Iberdomide
Experimental: Arm A3: Iberdomide Dose 3
Drug: Iberdomide
Active Comparator: Arm B: Lenalidomide
Drug: Lenalidomide

Nøkkelkriterier for kvalifikasjon

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 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 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

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For å rapportere bivirkninger (uønskede hendelser) eller reklamere på et legemiddel: Medisinsk informasjon

MLTNO2000046