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).

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Cyclophosphamide: Arm A: Cyclophosphamide will be given intravenously as lymphodepletion conditioning.

Fludarabine: Arm A: Fludarabine will be given intravenously as lymphodepletion conditioning.

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.

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Progression-Free Survival (PFS) — Up to approximately 13 years.
  PFS is defined as time from randomisation until progression as assessed by Blinded Independent Central Review, or death due to any cause, whichever occurs first.
• Minimal Residual Disease (MRD) negative Complete Response Rate (CRR) — Up to approximately 13 years.
  MRD negative CRR is defined as the proportion of participants with a MRD negative status and who have a response of CR or a stringent CR.

Trial sites (65)

+ 25 more sites — see the full list on the official registry below.