NCT07764978|RecruitingPhase 3DMCFDA Drug

Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT

DURGA-5

Phase III Open-Label, Randomised Study of Consolidation With AZD0120 (Dual-Targeting BCMA/CD19 CAR-T) vs Continuous Standard Therapy in NDMM Patients Ineligible for ASCT as Initial Therapy (DURGA-5)

AstraZeneca ClinicalTrials.gov

Compare

1 other identifier

D8312C00002

Study Type

interventional

Target

750

Locations

15 countries

Sites

124

Timeline

RegisteredAug 2026

StartedJun 2026

CompletionMay 2034

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

750

participants targeted

Target at P75+ for phase_3

Timeline

94mo left

Started Jun 2026

Longer than P75 for phase_3

Geographic Reach

15 countries

124 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.9 years study duration

Study Progress2%

Jun 2026May 2034

Study Start

First participant enrolled

June 26, 2026

Completed

5 days until next milestone

First Submitted

Initial submission to the registry

July 1, 2026

Completed

1 month until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2029

Expected

5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2034

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

2.5 years

First QC Date

July 1, 2026

Last Update Submit

August 10, 2026

Conditions

Newly Diagnosed Multiple Myeloma

Keywords

Newly Diagnosed Multiple Myeloma (NDMM)Multiple MyelomaAZD0120Cell TherapyCAR-TDURGA-5BCMACD19ASCT ineligibleTransplant ineligible

Outcome Measures

Primary Outcomes (2)

PFS in NDMM who are ineligible to receive ASCT is measured to demonstrate the superiority of IsaVRd or DRd induction followed by AZD0120 compared to IsaVRd or DRd induction followed by continuous DRd or IsaRd.
PFS: defined as time from randomisation until progression according to IMWG 2016 criteria as assessed by BICR, or death due to any cause, whichever occurs first.
Up to 9 years.
MRD negative CR rate at 9M in NDMM who are ineligible to receive ASCT is measured to demonstrate the superiority of IsaVRd or DRd induction followed by AZD0120 compared to IsaVRd or DRd induction followed by continuous DRd or IsaRd
MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status (at threshold of 10-5) and have a response of CR or sCR (according to the IMWG 2016 criteria) as assessed by BICR at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy.
Up to 9 years.

Secondary Outcomes (13)

Complete Response Rate
Up to 9 years.
Overall Survival
Up to 9 years.
Number and percentage of participants with adverse events as graded by CTCAE v6 and ASTCT Consensus Grading criteria
Up to 9 years.
Concentration of Circulating CAR-T+ Cells in Peripheral Blood
Up to 9 years.
Number and percentage of participants with incidence of ADAs against AZD0120
Up to 9 years.
+8 more secondary outcomes

Study Arms (2)

Arm A: Investigational Arm

EXPERIMENTAL

Arm A is the sequence of induction with IsaVRd or DRd, apheresis, optional bridging therapy, lymphodepletion (cyclophosphamide and fludarabine), and AZD0120.

Biological: AZD0120Biological: DaratumumabDrug: DexamethasoneBiological: IsatuximabDrug: LenalidomideDrug: BortezomibDrug: CyclophosphamideDrug: Fludarabine

Arm B: Control Arm

ACTIVE COMPARATOR

Arm B is the standard therapy induction with IsaVRd or DRd, followed by continuous IsaRd or DRd until disease progression or intolerable toxicity.

Biological: DaratumumabDrug: DexamethasoneBiological: IsatuximabDrug: LenalidomideDrug: Bortezomib

Interventions

AZD0120BIOLOGICAL

AZD0120, is a BCMA/CD19 dual CAR T-cell product, which is administered intravenously.

Arm A: Investigational Arm

DaratumumabBIOLOGICAL

Induction, optional bridging and continuous therapy.