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
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
Treatments tested in this trial
- AZD0120
- Daratumumab
- Dexamethasone
- Isatuximab
- Lenalidomide
- Bortezomib
- Cyclophosphamide
- Fludarabine
Treatment groups
750 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov