Health TrialsbyHealthPanel

Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT

ConditionNewly Diagnosed Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must be 18 years or older, at the time of signing the ICF.

Participant must have documented diagnosis of MM according to the IMWG diagnostic criteria.

Participant must have one or more of the following measurable disease criteria: (a) Serum M-protein level ≥1.0 g/dL, (b) Urine M-protein level ≥ 200 mg/24 h, (c)Serum immunoglobulin FLC ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda FLC ratio.

Participant must be deemed ineligible for ASCT while also having adequate organ function for CAR-T cell treatment.

Disqualifiers

Participant has active or prior CNS or meningeal involvement of MM.

Participant has primary amyloidosis, active plasma cell leukemia (≥5% circulating plasma cells), Waldenström macroglobulinemia, or POEMS syndrome.

Participant has significant neurological or psychiatric condition posing risk or impairing evaluation.

Participant has any other significant medical condition that increases unacceptable risk, interferes with therapy delivery, or confounds evaluation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AZD0120

    Biological/Vaccine

    AZD0120, is a BCMA/CD19 dual CAR T-cell product, which is administered intravenously.

  • Daratumumab

    Biological/Vaccine

    Induction, optional bridging and continuous therapy.

  • Dexamethasone

    Drug

    Induction, optional bridging and continuous therapy.

  • Isatuximab

    Biological/Vaccine

    Induction, optional bridging and continuous therapy.

  • Lenalidomide

    Drug

    Induction, optional bridging and continuous therapy.

  • Bortezomib

    Drug

    Induction therapy.

  • Cyclophosphamide

    Drug

    Lymphodepletion

  • Fludarabine

    Drug

    Lymphodepletion

Treatment groups

750 Participants
are divided into 2 treatment groups
Group A: Arm A: Investigational ArmExperimental treatment 8 interventions
Group B: Arm B: Control ArmActive comparator 5 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 9 years.
2

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.

Time frame
Up to 9 years.

Secondary outcomes

1

Complete Response Rate

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

Time frame
Up to 9 years.
2

Overall Survival

Time from randomisation until date of death due to any cause

Time frame
Up to 9 years.
3

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

Adverse Event Incidence

Time frame
Up to 9 years.
4

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.

Time frame
Up to 9 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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