Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT

Sintesi

This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of standard induction regimens (IsaVRd and DRd) followed by AZD0120 versus standard induction regimens followed by continuous therapy (IsaRd and DRd) in participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT) as initial therapy.

Idoneità

Disegno dello studio

Esiti misurati

1. Esito primario

   PFS in NDMM who are ineligible to receive ASCT is measured to demonstrate the superiority of IsaVRd or DRd induction followed by AZD0120 compared to IsaVRd or DRd induction followed by continuous DRd or IsaRd.

   PFS: defined as time from randomisation until progression according to IMWG 2016 criteria as assessed by BICR, or death due to any cause, whichever occurs first.

   Orizzonte temporale Up to 9 years.

2. Esito primario

   MRD negative CR rate at 9M in NDMM who are ineligible to receive ASCT is measured to demonstrate the superiority of IsaVRd or DRd induction followed by AZD0120 compared to IsaVRd or DRd induction followed by continuous DRd or IsaRd

   MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status (at threshold of 10-5) and have a response of CR or sCR (according to the IMWG 2016 criteria) as assessed by BICR at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy.

   Orizzonte temporale Up to 9 years.

3. Esito secondario

   Complete Response Rate

   The proportion of participants who achieved CR or better according to IMWG 2016 criteria, as assessed by BICR

   Orizzonte temporale Up to 9 years.

4. Esito secondario

   Overall Survival

   Time from randomisation until date of death due to any cause

   Orizzonte temporale Up to 9 years.

5. Esito secondario

   Number and percentage of participants with adverse events as graded by CTCAE v6 and ASTCT Consensus Grading criteria

   Adverse Event Incidence

   Orizzonte temporale Up to 9 years.

6. Esito secondario

   Concentration of Circulating CAR-T+ Cells in Peripheral Blood

   Quantification of circulating CAR-T+ cell levels by measuring CAR transgene in peripheral blood and CK parameters of AZD0120 will be measured to characterise the cellular kinetics of AZD0120 in blood.

   Orizzonte temporale Up to 9 years.

7. Esito secondario

   Number and percentage of participants with incidence of ADAs against AZD0120

   Assessment humoral immunogenicity of AZ0120 based on incidence of ADAs.

   Orizzonte temporale Up to 9 years.

8. Esito secondario

   Patient Reported Outcomes

   Change from baseline in bone pain severity measured by the European Organisation for Research and Treatment of Cancer Item Library 469 single bone pain item (EORTC IL469 - score range 0 - 100, with higher scores indicating worse bone pain) in participants with newly diagnosed multiple myeloma ineligible for autologous stem cell transplantation as initial therapy.

   Orizzonte temporale Up to 9 years.

9. Esito secondario

   Patient Reported Outcomes

   Change from baseline in fatigue severity, physical functioning, and global health status/quality of life measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 fatigue, physical functioning, and global health status/quality of life scales (EORTC QLQ-C30 - score range 0 to 100; higher scores indicate worse fatigue, better physical functioning, and better general health status/quality of life) in participants with newly diagnosed multiple myeloma ineligible for autologous stem cell transplantation as initial therapy.

   Orizzonte temporale Up to 9 years.

10. Esito secondario

    Overall Response Rate

    Proportion of participants who achieved PR or better according to IMWG 2016 criteria

    Orizzonte temporale Up to 9 years

11. Esito secondario

    Duration of Response

    Time from first documented confirmed response (PR or better) until date of documented PD per IMWG 2016 criteria or death due to any cause, whichever occurs first.

    Orizzonte temporale Up to 9 years

12. Esito secondario

    Time to Response

    Time from randomisation until the date of first documented objective response (PR or better), as assessed per IMWG 2016 criteria.

    Orizzonte temporale Up to 9 years

13. Esito secondario

    MRD negative CR rate

    Proportion of participants who have MRD negative status and have a response of CR or sCR (according to the IMWG 2016 criteria) at any time after the date of randomisation and before initiation of subsequent therapy.

    Orizzonte temporale Up to 9 years

14. Esito secondario

    Rate of sustained MRD negative CR

    Proportion of participants who have achieved MRD negative status and have a response of CR or sCR

    Orizzonte temporale Up to 9 years

15. Esito secondario

    Progression Free Survival 2 (PFS2)

    Time from randomisation to progression on next line of therapy, as assessed by Investigator, or death due to any cause, whichever occurs first

    Orizzonte temporale Up to 9 years

Date

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Centri

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