AZD0120
BiologicalArm 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.
NCT Number: NCT07735637
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.
Trial opening soon.
Get Notified18 year–130 year
All sexes
Interventional
Phase 3
Research Site, Brisbane, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Arm A: Cyclophosphamide will be given intravenously as lymphodepletion conditioning.
Arm A: Fludarabine will be given intravenously as lymphodepletion conditioning.
Arm B - Autologous stem cell transplant: High-dose melphalan will be given over 1-2 days, followed by autologous stem cell rescue.
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 13 years.
OS is defined as time from randomisation until date of death due to any cause.
Time frame: Up to approximately 13 years.
CRR (CR or stringent CR rate) is defined as the proportion of participants who achieved CR or better and as assessed by Blinded Independent Central Review.
Time frame: Up to approximately 13 years.
ORR is defined as the proportion of participants with a response (complete, partial or very good partial response) as assessed by Blinded Independent Central Review.
Time frame: Up to approximately 13 years.
DoR is defined as the time from first response to progression or death
Time frame: Up to approximately 13 years.
TTR is defined as the time from randomisation to first response
Time frame: Up to approximately 13 years.
To evaluate safety in terms of the number of participants experiencing an Adverse Event.
Contact information is provided by the study sponsor or research team.
AstraZeneca
Industry
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)
Acronym: DURGA-6
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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