Recruiting
Phase 3

AZD0120 vs. Standard Regimens

Sponsor:

AstraZeneca

Code:

NCT07391657

Conditions

Relapsed Refractory Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AZD0120

Daratumumab

Carfilzomib

Dexamethasone

Bortezomib

Study Details

Brief 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.

Conditions

Relapsed Refractory Multiple Myeloma

Study ID

NCT07391657

Start date

Feb 23, 2026

Status verified date

Aug, 2026

Completion date

Jul 29, 2030

Anticipated

Primary completion date

Jun 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

508 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

AZD0120

active comparator: Arm B

1 of the following 4 standard regimens per investigator choice; DKd, DPd, PVd, Kd.

Interventions

AZD0120

CAR-T Cells

Daratumumab

Daratumumab

Carfilzomib

Carfilzomib

Dexamethasone

Dexamethasone

Bortezomib

Bortezomib

Pomalidomide

Pomalidomides

Primary outcome measure

  • To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of PFS in participants with RRMM. [ 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. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Denver, Colorado, United States, 80218

Research Site

Recruiting

New Haven, Connecticut, United States, 06510

Research Site

Recruiting

Atlanta, Georgia, United States, 30322

Research Site

Recruiting

Louisville, Kentucky, United States, 40207

Research Site

Recruiting

New York, New York, United States, 10029

Research Site

Recruiting

New York, New York, United States, 10065

Research Site

Recruiting

Charlotte, North Carolina, United States, 28204

Research Site

Recruiting

Winston-Salem, North Carolina, United States, 27103

Research Site

Recruiting

Nashville, Tennessee, United States, 37203

Research Site

Recruiting

Austin, Texas, United States, 78704

Research Site

Recruiting

Houston, Texas, United States, 77030

Research Site

Recruiting

Seattle, Washington, United States, 98104

Research Site

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Research Site

Recruiting

Montreal, Quebec, Canada, H3A 1A1

More Information

Sponsor

AstraZeneca

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • BCMA
  • CAR-T
  • CD19

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-22. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-01.