A Phase III, Multicentre Study to Evaluate Consolidation Treatment With AZD0120 Compared With ASCT, in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible (DURGA-6).
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, Cyclophosphamide, Fludarabine, Melphalan (part of ASCT).
- Who it may be relevant to
- Registry conditions: Newly Diagnosed Multiple Myeloma (NDMM). Basic parameters: 18 years — 130 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, Denmark +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, Multicentre, Randomised Study Comparing Consolidation Treatment With AZD0120, an Autologous Dual Targeting Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19, Versus Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible (TE NDMM) (DURGA-6)
Overview
The purpose of this study is to measure the efficacy of AZD0120 compared with ASCT in terms of progression-free survival (PFS) according to the International Myeloma Working Group (IMWG) criteria 2016, and MRD negative complete response (CR) rate at 9 months as assessed by Blinded Independent Central Review (BICR), in participants with TE NDMM. Study details include: * The study duration is estimated to be up to 13 years from the date the first participant is randomised. * For participants in Arm A (AZD0120), the total duration of participant follow-up will be 15 years (including a Long Term Follow-up study) after the last participant has received the AZD0120 infusion. * The treatment duration will be:- Arm A (AZD0120): lymphodepletion over 3 days, a single-day infusion of AZD0120, followed by a maximum of 2 years lenalidomide monotherapy maintenance treatment. * Arm B (ASCT): conditioning therapy over 24 to 48 hours, ASCT, followed by a maximum of 2 years lenalidomide monotherapy maintenance treatment. Disclosure Statement: This is an open-label, randomised study with 2 treatment arms.
Interventions
- Biological AZD0120
Arm A: AZD0120 - autologous BCMA/CD19 dual-targeting CAR-T cells. Participants will receive lymphodepletion conditioning (cyclophosphamide and fludarabine) followed by AZD0120 CAR-T cell infusion. - Drug Cyclophosphamide
Arm A: Cyclophosphamide will be given intravenously as lymphodepletion conditioning. - Drug Fludarabine
Arm A: Fludarabine will be given intravenously as lymphodepletion conditioning. - Drug Melphalan (part of ASCT)
Arm B - Autologous stem cell transplant: High-dose melphalan will be given over 1-2 days, followed by autologous stem cell rescue. - Drug Lenalidomide
Arm A and Arm B: Lenalidomide maintenance treatment will be started in both Arm A and Arm B after AZD0120 therapy or ASCT, respectively. Lenalidomide maintenance on study will be continued up to 2 years.
Primary outcome measures
- Progression-Free Survival (PFS) [Time frame: Up to approximately 13 years.]
- Minimal Residual Disease (MRD) negative Complete Response Rate (CRR) [Time frame: Up to approximately 13 years.]
Secondary outcome measures (6)
- Secondary: Overall Survival (OS) [Time frame: Up to approximately 13 years.]
- Secondary: Complete Response Rate (CRR) [Time frame: Up to approximately 13 years.]
- Secondary: Overall Response Rate (ORR) [Time frame: Up to approximately 13 years.]
- Secondary: Duration of Response (DoR) [Time frame: Up to approximately 13 years.]
- Other secondary: Time to Response (TTR) [Time frame: Up to approximately 13 years.]
- Safety - Adverse Events [Time frame: Up to approximately 13 years.]
Eligibility criteria
Inclusion criteria
- ≥18 years of age.
- Documented diagnosis of NDMM according to IMWG diagnostic criteria.
- Documented measurable disease at diagnosis (serum M-protein ≥ 1.0 g/dL, urine M-protein 200 mg/24 hour, or serum Ig FLC 10 mg/dL (100 mg/L) and abnormal serum Ig kappa lambda FLC ratio)
- Must have completed 4 to 6 cycles of induction therapy with any of the following approved regimens: anti-CD38+VRd, DVTd, DRd or VRd
- Participant must have at least SD or better per IMWG response criteria (2016) after completion of induction, and prior to randomisation.
- ECOG performance status score of 0 or 1.
- Eligible for treatment with high-dose melphalan (200 mg/m²) followed by ASCT.
- Adequate organ and bone marrow function.
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 (at diagnosis and/or at time of screening), Waldenstrom macroglobulinemia or POEMS syndrome.
- Significant neurological or psychiatric condition
- Significant medical condition that places the participant at an unacceptable risk for treatment-related complications
- Participants who required the introduction of an additional agent therapy due to inadequate response.
- Prior T-cell engager therapy directed at any target.
- Prior CAR-T and/or CAR-NK cell therapy directed at any target for any indications
- Prior any therapy that is targeted to BCMA and CD19.
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 · 10 centers
- Research Site — Tampa
- Research Site — Atlanta
- Research Site — Atlanta
- Research Site — Chicago
- Research Site — Detroit
- Research Site — Rochester
- Research Site — Cleveland
- Research Site — San Antonio
- … and 2 more centers
Germany · 8 centers
- Research Site — Berlin
- Research Site — Dresden
- Research Site — Essen
- Research Site — Freiburg im Breisgau
- Research Site — Hamburg
- Research Site — Leipzig
- Research Site — München
- Research Site — Oldenburg
Spain · 7 centers
- Research Site — Badalona
- Research Site — Barcelona
- Research Site — El Palmar
- Research Site — Madrid
- Research Site — Salamanca
- Research Site — Santander
- Research Site — Seville
Australia · 6 centers
- Research Site — Brisbane
- Research Site — Camperdown
- Research Site — Darlinghurst
- Research Site — Fitzroy
- Research Site — Melbourne
- Research Site — Nedlands
Italy · 6 centers
- Research Site — Bologna
- Research Site — Milan
- Research Site — Milan
- Research Site — Rome
- Research Site — Rozzano
- Research Site — Torino
Poland · 6 centers
- Research Site — Gdansk
- Research Site — Gliwice
- Research Site — Kielce
- Research Site — Krakow
- Research Site — Lublin
- Research Site — Wroclaw
France · 5 centers
- Research Site — Lille
- Research Site — Nantes
- Research Site — Paris
- Research Site — Paris
- Research Site — Toulouse
South Korea · 4 centers
- Research Site — Seoul
- Research Site — Seoul
- Research Site — Seoul
- Research Site — Seoul
Brazil · 3 centers
- Research Site — Salvador
- Research Site — São Paulo
- Research Site — São Paulo
Denmark · 3 centers
- Research Site — Aarhus
- Research Site — København Ø
- Research Site — Odense
Singapore · 2 centers
- Research Site — Singapore
- Research Site — Singapore
United Kingdom · 2 centers
- Research Site — Cambridge
- Research Site — London
Canada · 1 center
- Research Site — Calgary
Norway · 1 center
- Research Site — Oslo
Taiwan · 1 center
- Research Site — Taipei
Identifiers
NCT: NCT07735637 · D8316C00001 · AZD0120