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    Association details:
    Biomarker:Chr t(14;16)
    Cancer:Multiple Myeloma
    Regimen:Isa-KRd (carfilzomib + dexamethasone injection + lenalidomide + Sarclisa (isatuximab-irfc))
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASH 2022
    Title:

    3239 A Phase II Study of Once Weekly Carfilzomib, Lenalidomide, Dexamethasone, and Isatuximab in Newly Diagnosed, Transplant-Eligible Multiple Myeloma (The SKylaRk Trial)

    Published date:
    11/03/2022
    Excerpt:
    For maintenance, patients were stratified based on cytogenetics (high-risk cytogenetics included deletion 17p, gain of 1q, and translocations t(4:14), t(14;16), t(14;20))….Of the 47 patients evaluable for response after 4 cycles, the ORR was 100% and 89% (42/47) achieved a very good partial response (VGPR) or better and 40% (19/47) a CR....Early data suggest that Isa-KRd induces deep responses in patients with NDMM.
    DOI:
    https://doi.org/10.1182/blood-2022-156328
    Trial ID:
    SKylaRk
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    EHA 2021
    Title:

    UPDATED INTERIM ANALYSIS OF THE GMMG-CONCEPT TRIAL INVESTIGATING ISATUXIMAB, CARFILZOMIB, LENALIDOMIDE, AND DEXAMETHASONE (ISA-KRD) IN FRONT-LINE TREATMENT OF HIGH-RISK MULTIPLE MYELOMA

    Published date:
    05/12/2021
    Excerpt:
    HR MM is defined by the presence of del17p or t(4;14) or t(14;16) or > 3 copies 1q21 in combination with ISS II or III stage disease….updated IA analysis was performed with a median follow-up of 24.9 months. For the overall population analysed, 12- and 24-month PFS (95%>confidence level) was 79.6% (68.3%; 90.9%) and 75.5% (63.5%; 87.6%).
    Trial ID:
    GMMG-CONCEPT
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    J Clin Oncol
    Title:

    Depth of response to isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd) in front-line treatment of high-risk multiple myeloma: Interim analysis of the GMMG-CONCEPT trial

    Published date:
    05/25/2020
    Excerpt:
    Pts receive 6 cycles of Isa-KRd induction, 4 cycles of Isa-KRd consolidation and Isa-KR maintenance….HR MM was defined by del17p in 52%, t(4;14) in 38%, t(14;16) in 12% and > 3 copies 1q21 in 42%....ORR was 100%, with 5 pts (10.0%) showing partial response (PR), 22 (44.0%; including 4 in arm B) very good partial response (VGPR) and 23 (46.0 %) complete response (CR).
    DOI:
    10.1200/JCO.2020.38.15_suppl.8508
    Trial ID:
    GMMG-CONCEPT