Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT
Condition(s) studied
Investigational drug(s) / intervention(s)
AZD0120: AZD0120, is a BCMA/CD19 dual CAR T-cell product, which is administered intravenously.
Daratumumab: Induction, optional bridging and continuous therapy.
Dexamethasone: Induction, optional bridging and continuous therapy.
Isatuximab: Induction, optional bridging and continuous therapy.
Lenalidomide: Induction, optional bridging and continuous therapy.
Bortezomib: Induction therapy.
Cyclophosphamide: Lymphodepletion
Fludarabine: Lymphodepletion
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.
Eligibility
Primary outcome measure(s)
- 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. — Up to 9 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. - 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 — Up to 9 years.
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.
Trial sites (124)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Gilbert | Arizona | Not Yet Recruiting |
| Research Site | Phoenix | Arizona | Not Yet Recruiting |
| Research Site | Tucson | Arizona | Not Yet Recruiting |
| Research Site | Orange | California | Not Yet Recruiting |
| Research Site | Santa Monica | California | Not Yet Recruiting |
| Research Site | Aurora | Colorado | Not Yet Recruiting |
| Research Site | Denver | Colorado | Not Yet Recruiting |
| Research Site | New Haven | Connecticut | Not Yet Recruiting |
| Research Site | Coral Gables | Florida | Not Yet Recruiting |
| Research Site | Tampa | Florida | Not Yet Recruiting |
| Research Site | Atlanta | Georgia | Not Yet Recruiting |
| Research Site | Chicago | Illinois | Not Yet Recruiting |
| Research Site | Iowa City | Iowa | Not Yet Recruiting |
| Research Site | Wichita | Kansas | Not Yet Recruiting |
| Research Site | Louisville | Kentucky | Not Yet Recruiting |
| Research Site | Baton Rouge | Louisiana | Not Yet Recruiting |
| Research Site | Baltimore | Maryland | Not Yet Recruiting |
| Research Site | Detroit | Michigan | Not Yet Recruiting |
| Research Site | St Louis | Missouri | Not Yet Recruiting |
| Research Site | East Brunswick | New Jersey | Not Yet Recruiting |
| Research Site | Albany | New York | Not Yet Recruiting |
| Research Site | New Hyde Park | New York | Not Yet Recruiting |
| Research Site | New York | New York | Not Yet Recruiting |
| Research Site | New York | New York | Not Yet Recruiting |
| Research Site | New York | New York | Not Yet Recruiting |
| Research Site | The Bronx | New York | Not Yet Recruiting |
| Research Site | Chapel Hill | North Carolina | Not Yet Recruiting |
| Research Site | Charlotte | North Carolina | Not Yet Recruiting |
| Research Site | Durham | North Carolina | Not Yet Recruiting |
| Research Site | Winston-Salem | North Carolina | Not Yet 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 | Columbus | Ohio | Not Yet Recruiting |
| Research Site | Montgomery | Ohio | Not Yet Recruiting |
| Research Site | Portland | Oregon | Not Yet Recruiting |
| Research Site | Nashville | Tennessee | Not Yet Recruiting |
| Research Site | Nashville | Tennessee | Not Yet Recruiting |
| Research Site | Dallas | Texas | Not Yet Recruiting |
| Research Site | Houston | Texas | Not Yet Recruiting |
+ 84 more sites — see the full list on the official registry below.
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Other trials for the same condition
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 NCT07764978 on ClinicalTrials.gov ↗ ← All trials in Italy