AZD0120 added to induction in multiple myeloma patients ineligible for stem cell transplant

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 trial is a randomized, multicenter study comparing induction regimens IsaVRd or DRd followed by a one-time AZD0120 dose versus induction regimens followed by ongoing IsaRd or DRd. The main goal is to see if the single AZD0120 dose improves progression-free survival and MRD-negative complete responses at 9 months after randomization, using IMWG criteria and blinded central review. Participants are adults with NDMM ineligible for ASCT and must have measurable disease and adequate organ function. The study includes AZD0120, daratumumab, dexamethasone, isatuximab, and lenalidomide as part of the treatment approach.

Why it matters

Who can join: the full rules

INCLUSION CRITERIA:

1. Participants must be 18 years or older, at the time of signing the ICF.
2. Participant must have documented diagnosis of MM according to the IMWG diagnostic criteria.
3. Participant must have one or more of the following measurable disease criteria: (a) Serum M-protein level ≥1.0 g/dL, (b) Urine M-protein level ≥ 200 mg/24 h, (c)Serum immunoglobulin FLC ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda FLC ratio.
4. Participant must be deemed ineligible for ASCT while also having adequate organ function for CAR-T cell treatment.
5. Participant is a candidate to receive at least one of the regimens (IsaVRd or DRd) as determined by the Investigator.
6. ECOG performance status Grade of 0 to 2.
7. Participant must have adequate organ and bone marrow function.

EXCLUSION CRITERIA:

1. Participant has active or prior CNS or meningeal involvement of MM.
2. Participant has primary amyloidosis, active plasma cell leukemia (≥5% circulating plasma cells), Waldenström macroglobulinemia, or POEMS syndrome.
3. Participant has significant neurological or psychiatric condition posing risk or impairing evaluation.
4. Participant has any other significant medical condition that increases unacceptable risk, interferes with therapy delivery, or confounds evaluation.
5. Participant has a history of a prior non-haematologic malignancy unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years.
6. Participant has a history of haematologic malignancies, other than MM, regardless of remission status.
7. Participant is positive for any of the following:

   1. HIV: Known to be seropositive for HIV (including any history of HIV).
   2. Chronic or active hepatitis B.
   3. Active hepatitis C: Hepatitis C infection.
   4. Additional local requirements for the testing for infectious diseases and exclusions of applicable participants should be followed per local regulations.
8. Participant has clinically significant cardiovascular disease.
9. Participant has COPD with an FEV1 \< 50% of predicted normal.
10. Additional exclusion for participants who are planned to receive IsaVRd as induction: Participant has peripheral neuropathy Grade 4, Grade 3, Grade 2, or Grade 1 with pain.

Where it's running

• Research Site
  Fitzroy, Australia Recruiting
• Research Site
  Gilbert, Arizona, United States Not yet recruiting
• Research Site
  Phoenix, Arizona, United States Not yet recruiting
• Research Site
  Tucson, Arizona, United States Not yet recruiting
• Research Site
  Orange, California, United States Not yet recruiting
• Research Site
  Santa Monica, California, United States Not yet recruiting

+74 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.