AZD0120 consolidation vs ASCT in transplant-eligible newly diagnosed multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3, multicenter trial compares consolidation therapy with AZD0120 to autologous stem cell transplant (ASCT) in adults with newly diagnosed, transplant-eligible multiple myeloma. Participants will be randomized to receive AZD0120 with lymphodepletion and lenalidomide maintenance or to undergo ASCT with lenalidomide maintenance, with follow-up extending up to 15 years. Primary endpoints include progression-free survival by IMWG criteria and MRD-negative complete response rate at 9 months, assessed by blinded central review. Additional long-term follow-up is planned to evaluate durability of response and safety. Eligible patients must have completed induction therapy and meet performance and organ-function criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥18 years of age.
* Documented diagnosis of NDMM according to IMWG diagnostic criteria.
* Documented measurable disease at diagnosis (serum M-protein ≥ 1.0 g/dL, urine M-protein 200 mg/24 hour, or serum Ig FLC 10 mg/dL (100 mg/L) and abnormal serum Ig kappa lambda FLC ratio)
* Must have completed 4 to 6 cycles of induction therapy with any of the following approved regimens: anti-CD38+VRd, DVTd, DRd or VRd
* Participant must have at least SD or better per IMWG response criteria (2016) after completion of induction, and prior to randomisation.
* ECOG performance status score of 0 or 1.
* Eligible for treatment with high-dose melphalan (200 mg/m²) followed by ASCT.
* Adequate organ and bone marrow function.

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 (at diagnosis and/or at time of screening), Waldenstrom macroglobulinemia or POEMS syndrome.
* Significant neurological or psychiatric condition
* Significant medical condition that places the participant at an unacceptable risk for treatment-related complications
* Participants who required the introduction of an additional agent therapy due to inadequate response.
* Prior T-cell engager therapy directed at any target.
* Prior CAR-T and/or CAR-NK cell therapy directed at any target for any indications
* Prior any therapy that is targeted to BCMA and CD19.

Where it's running

• Research Site
  Fitzroy, Australia Recruiting
• Research Site
  London, United Kingdom Recruiting
• Research Site
  Gilbert, Arizona, United States Not yet recruiting
• Research Site
  Goodyear, Arizona, United States Not yet recruiting
• Research Site
  Phoenix, Arizona, United States Not yet recruiting
• Research Site
  Los Angeles, California, United States Withdrawn

+64 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.