Recruiting NCT07391657

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)

Phase III Interventional Relapsed Refractory Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: AZD0120, Daratumumab, Carfilzomib, Dexamethasone.
Who it may be relevant to: Registry conditions: Relapsed Refractory Multiple Myeloma. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Brazil, Canada, China +10
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase III Open-label, Randomised, Multicentre Study Comparing AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CART) Therapy Directed Against BCMA and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma.

Overview

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.

Interventions

Biological AZD0120
CAR-T Cells
Drug Daratumumab
Daratumumab
Drug Carfilzomib
Carfilzomib
Drug Dexamethasone
Dexamethasone
Drug Bortezomib
Bortezomib
Drug Pomalidomide
Pomalidomides

Primary outcome measures

To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of PFS in participants with RRMM. [Time frame: 3 years]
To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of MRD negativity rate at 9 months in participants with RRMM. [Time frame: 2 years]

Secondary outcome measures (3)

To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of CRR in participants with RRMM. [Time frame: 2 years]
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of ORR in participants with RRMM. [Time frame: 2 years]
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of OS in participants with RRMM. [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

Age ≥ 18 years
Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria
Documented evidence of measurable disease:

Serum M-protein level ≥ 1 g/dL
Urine M-protein level ≥ 200 mg/24h
Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio
Documented evidence of PD by IMWG 2016 criteria based on investigator's determination during or after the most recent line of therapy. Participants with only 1 prior line of therapy must have progressed within 47 months of a stem cell transplant, or if not transplanted, then within 42 months of starting initial therapy
Received 1 to 3 lines of prior therapy including an IMiD and either a PI or a CD38 antibody. Participant must have undergone at least 2 complete cycles of treatment for each line of therapy, unless PD was the best response to the line of therapy
Eligible to receive at least one of the standard regimens (DKd, PVd, DPd, or Kd) as determined by the Investigator.
ECOG performance status score of 0 to 1
Adequate hematology and chemistry laboratory values:

Haemoglobin ≥ 8.0 g/dL
Absolute neutrophil count ≥ 1 × 10\^9/L (1000 per mm3)
Platelet count ≥ 75 × 10\^9/L (75000 per mm3) in participants with < 50% of bone marrow nucleated cells are plasma cells or ≥ 50 × 10\^9/L (50000 per mm3) in participants with ≥ 50% of bone marrow nucleated cells are plasma cells
Absolute lymphocyte count ≥ 300/µL (0.3 × 109/L)
Total bilirubin ≤ 1.5 × ULN in the absence of Gilbert's syndrome or ≤ 3 × ULN if the participant has Gilbert's syndrome. AST and ALT≤ 3.0 × ULN. CrCl by Cockcroft and Gault method ≥ 30 mL/minute

Exclusion criteria

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
Significant medical condition that places the participant at an unacceptable risk for treatment-related complications
Previously received any prior BCMA-targeted treatment
Previously received CAR-T or CAR-NK therapy directed at any target
Previously received T-cell engager therapy directed at any target
Previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of randomization

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 50 centers

Research Site — Gilbert
Research Site — Phoenix
Research Site — Tucson
Research Site — La Jolla
Research Site — Sacramento
Research Site — Santa Monica
Research Site — Denver
Research Site — New Haven
… and 42 more centers

China · 24 centers

Research Site — Beijing
Research Site — Beijing
Research Site — Changchun
Research Site — Changsha
Research Site — Changsha
Research Site — Chongqing
Research Site — Guangzhou
Research Site — Guangzhou
… and 16 more centers

Germany · 11 centers