A Phase 3 interventional study of AZD0120 and Daratumumab in Relapsed Refractory Multiple Myeloma, sponsored by AstraZeneca. Recruiting at 143 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
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.
Documented evidence of measurable disease:
Adequate hematology and chemistry laboratory values:
Exclusion Criteria:
AZD0120
Biological: AZD0120
1 of the following 4 standard regimens per investigator choice; DKd, DPd, PVd, Kd.
Drug: Daratumumab · Drug: Carfilzomib · Drug: Dexamethasone · Drug: Bortezomib · Drug: Pomalidomide
CAR-T Cells
Daratumumab
Also known as: Darzalex
Carfilzomib
Also known as: Kyprolis
Dexamethasone
Bortezomib
Also known as: Velcade
Pomalidomides
Also known as: Pomalyst and Imnovid
To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of PFS in participants with RRMM.
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.
Time frame: 3 years
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.
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.
Time frame: 2 years
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of CRR in participants with RRMM.
Time frame: 2 years
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of ORR in participants with RRMM.
Time frame: 2 years
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of OS in participants with RRMM.
Time frame: 5 years
Showing the first 100 of 143 sites across 15 countries.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Sap
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