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)
Condition(s) studied
Investigational drug(s) / intervention(s)
AZD0120: CAR-T Cells
Daratumumab: Daratumumab
Carfilzomib: Carfilzomib
Dexamethasone: Dexamethasone
Bortezomib: Bortezomib
Pomalidomide: Pomalidomides
Study summary
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.
Eligibility
Primary outcome measure(s)
- To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of PFS in participants with RRMM. — 3 years
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. - To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of MRD negativity rate at 9 months in participants with RRMM. — 2 years
MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status and have a response of CR or sCR (according to the IMWG 2016 criteria) at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy.
Trial sites (143)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Gilbert | Arizona | Not Yet Recruiting |
| Research Site | Phoenix | Arizona | Withdrawn |
| Research Site | Tucson | Arizona | Not Yet Recruiting |
| Research Site | La Jolla | California | Withdrawn |
| Research Site | Sacramento | California | Not Yet Recruiting |
| Research Site | Santa Monica | California | Not Yet Recruiting |
| Research Site | Denver | Colorado | Recruiting |
| Research Site | New Haven | Connecticut | Recruiting |
| Research Site | Washington D.C. | District of Columbia | Not Yet Recruiting |
| Research Site | Coral Gables | Florida | Withdrawn |
| Research Site | Tampa | Florida | Not Yet Recruiting |
| Research Site | Atlanta | Georgia | Recruiting |
| Research Site | Chicago | Illinois | Not Yet Recruiting |
| Research Site | Park Ridge | Illinois | Not Yet Recruiting |
| Research Site | Iowa City | Iowa | Withdrawn |
| Research Site | Kansas City | Kansas | Not Yet Recruiting |
| Research Site | Louisville | Kentucky | Recruiting |
| Research Site | Boston | Massachusetts | Not Yet Recruiting |
| Research Site | Boston | Massachusetts | Not Yet Recruiting |
| Research Site | Boston | Massachusetts | Withdrawn |
| Research Site | Detroit | Michigan | Withdrawn |
| Research Site | Detroit | Michigan | Withdrawn |
| Research Site | Rochester | Minnesota | Withdrawn |
| Research Site | Albany | New York | Not Yet Recruiting |
| Research Site | New York | New York | Withdrawn |
| Research Site | New York | New York | Recruiting |
| Research Site | New York | New York | Withdrawn |
| Research Site | New York | New York | Recruiting |
| Research Site | Rochester | New York | Withdrawn |
| Research Site | The Bronx | New York | Withdrawn |
| Research Site | Chapel Hill | North Carolina | Not Yet Recruiting |
| Research Site | Charlotte | North Carolina | Not Yet Recruiting |
| Research Site | Charlotte | North Carolina | Recruiting |
| Research Site | Winston-Salem | North Carolina | Recruiting |
| Research Site | Winston-Salem | North Carolina | Not Yet Recruiting |
| Research Site | Cincinnati | Ohio | Not Yet Recruiting |
| Research Site | Cleveland | Ohio | Not Yet Recruiting |
| Research Site | Portland | Oregon | Not Yet Recruiting |
| Research Site | Charleston | South Carolina | Withdrawn |
| Research Site | Nashville | Tennessee | Recruiting |
+ 103 more sites — see the full list on the official registry below.
On this site
📄 Darzalex (daratumumab) drug profile →More AstraZeneca trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07391657 on ClinicalTrials.gov ↗ ← All trials in Italy