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Looking for participantsPhase3

A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)

Sponsor: AstraZeneca

NCT ID: NCT07391657

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AZD0120 (biological), Daratumumab (drug), Carfilzomib (drug), Dexamethasone (drug)
How long the study runs
Study runs about 53 months (dates as stated)
About the drug or intervention
AZD0120 — biological: CAR-T Cells · Daratumumab — drug: Daratumumab · Carfilzomib — drug: Carfilzomib · Dexamethasone — drug: Dexamethasone · Bortezomib — drug: Bortezomib · Pomalidomide — drug: Pomalidomides
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
508
Started
2026-02-23
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for relapsed refractory multiple myeloma
  • • Phase3 - 508 participants
  • • This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of AZD0120 versus standard regimens (DKd \[daratumumab, carfilzomib, and dexamethasone\], DPd \[daratumumab, pomalidomide, and dexamethasone\], PVd \[pomalidomide, bortezomib and dexamethasone\], or Kd \[carfilzomib and dexamethasone\]) in participants with RRMM

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with relapsed refractory multiple myeloma

Where?

  • • Birmingham - Research Site
  • • Bristol - Research Site
  • • Glasgow, Scotland - Research Site
  • • London - Research Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of AZD0120 versus standard regimens (DKd \[daratumumab, carfilzomib, and dexamethasone\], DPd \[daratumumab, pomalidomide, and dexamethasone\], PVd \[pomalidomide, bortezomib and dexamethasone\], or Kd \[carfilzomib and dexamethasone\]) in participants with RRMM.

Relapsed Refractory Multiple Myeloma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

CD38

Treatment history

Treatments you must have had:

  • ✓ of therapy must have progressed within 47 months of a stem cell transplant
  • ✓ including an IMiD

What the study is looking for

  • ✓Age ≥ 18 years
  • ✓Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria
  • ✓Documented evidence of cancer that can be measured on scans:
  • ✓Serum M-protein level ≥ 1 g/dL
  • ✓Urine M-protein level ≥ 200 mg/24h

Who cannot take part

  • ✗Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.
  • ✗Primary amyloidosis, active plasma cell leukaemia, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly...
  • ✗Participants with primary refractory MM (failed to generate at least a minimal response to any prior therapy)
  • ✗Significant neurological or psychiatric condition
  • ✗Significant medical condition that places the participant at an unacceptable risk for treatment-related complications
See the full criteria
Inclusion Criteria: * Age ≥ 18 years * Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria * Documented evidence of measurable disease: 1. Serum M-protein level ≥ 1 g/dL 2. Urine M-protein level ≥ 200 mg/24h 3. Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio * Documented evidence of PD by IMWG 2016 criteria based on investigator's determination during or after the most recent line of therapy. Participants with only 1 prior line of therapy must have progressed within 47 months of a stem cell transplant, or if not transplanted, then within 42 months of starting initial therapy * Received 1 to 3 lines of prior therapy including an IMiD and either a PI or a CD38 antibody. Participant must have undergone at least 2 complete cycles of treatment for each line of therapy, unless PD was the best response to the line of therapy * Eligible to receive at least one of the standard regimens (DKd, PVd, DPd, or Kd) as determined by the Investigator. * ECOG performance status score of 0 to 1 * Adequate hematology and chemistry laboratory values: 1. Haemoglobin ≥ 8.0 g/dL 2. Absolute neutrophil count ≥ 1 × 10\^9/L (1000 per mm3) 3. Platelet count ≥ 75 × 10\^9/L (75000 per mm3) in participants with \< 50% of bone marrow nucleated cells are plasma cells or ≥ 50 × 10\^9/L (50000 per mm3) in participants with ≥ 50% of bone marrow nucleated cells are plasma cells 4. Absolute lymphocyte count ≥ 300/µL (0.3 × 109/L) 5. Total bilirubin ≤ 1.5 × ULN in the absence of Gilbert's syndrome or ≤ 3 × ULN if the participant has Gilbert's syndrome. AST and ALT≤ 3.0 × ULN. CrCl by Cockcroft and Gault method ≥ 30 mL/minute 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, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome. * Participants with primary refractory MM (failed to generate at least a minimal response to any prior therapy) * Significant neurological or psychiatric condition * Significant medical condition that places the participant at an unacceptable risk for treatment-related complications * Previously received any prior BCMA-targeted treatment * Previously received CAR-T or CAR-NK therapy directed at any target * Previously received T-cell engager therapy directed at any target * Previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of randomization

Where Is This Study? (4 UK sites)

Research Site

Birmingham B9 5SS, United Kingdom

Recruiting

Research Site

Bristol BS2 8ED, United Kingdom

Recruiting

Research Site

Glasgow, Scotland G12 0YN, United Kingdom

NOT_YET_RECRUITING

Research Site

London SM2 5NG, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09