A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)

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 AZD0120 versus standard regimens (DKd \[daratumumab, carfilzomib, and dexamethasone\], DPd \[daratumumab, pomalidomide, and dexamethasone\], PVd \[pomalidomide, bortezomib and dexamethasone\], or Kd \[carfilzomib and dexamethasone\]) in participants with RRMM.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria

Serum M-protein level ≥ 1 g/dL

Urine M-protein level ≥ 200 mg/24h

Disqualifiers

Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.

Primary amyloidosis, active plasma cell leukaemia, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome.

Participants with primary refractory MM (failed to generate at least a minimal response to any prior therapy)

Significant neurological or psychiatric condition

Trial design

Treatments tested in this trial

  • AZD0120
  • Daratumumab
  • Carfilzomib
  • Dexamethasone
  • Bortezomib
  • Pomalidomide

Treatment groups

508 Participants
are divided into 2 treatment groups

Sponsors and collaborators