MedTrace Logo

Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT

NCT07764978 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2026-08-14

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

AZD0120

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

BIOLOGICAL

Daratumumab

Induction, optional bridging and continuous therapy.

DRUG

Dexamethasone

Induction, optional bridging and continuous therapy.

BIOLOGICAL

Isatuximab

Induction, optional bridging and continuous therapy.

DRUG

Lenalidomide

Induction, optional bridging and continuous therapy.

DRUG

Bortezomib

Induction therapy.

DRUG

Cyclophosphamide

Lymphodepletion

DRUG

Fludarabine

Lymphodepletion

Sponsors & Collaborators

Principal Investigators

  • Jen Brudno, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-26
Primary Completion
2029-01-11
Completion
2034-05-12
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Japan
  • Poland
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07764978 on ClinicalTrials.gov