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Trial NCT05850234

AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)

Phase
Phase 1/2
Sponsor
AstraZeneca
Conditions
Relapsed/Refractory Multiple Myeloma
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

Inclusion Criteria: * ≥18 years of age at the time of consent. * ECOG performance status of 0 or 1.Performance status * Documented diagnosis of MM per IMWG diagnostic criteria. * Participant must have received at least 3 prior lines of therapy, which include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody. * Have documented evidence of progressive disease per IMWG criteria. * Participant must have measurable disease at screening. * Participant must have adequate bone marrow and organ function (hematological, hepatic and renal) demonstrated at screening. Exclusion Criteria : * Participant has a history of significant toxicity during prior CAR T-cell therapy and T-cell engaging therapy. * Participant has a history of a prior non-hematologic malignancy, unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years.Prior malignancy Some exceptions may apply. * Participant has significant cardiac, neurological, or psychiatric conditions.Cardiac * Any other significant medical conditions such as: * Serious active or uncontrolled infection * Active autoimmune disease or a history of autoimmune disease within 2 years * Active plasma cell leukemia at the time of screening * Clinical evidence of dementia or altered mental status, or stroke, intracranial haemorrhage, or seizure within 6 months before signing informed consent form (ICF). * Known active or prior history of central nervous system involvement or exhibits clinical signs of meningeal involvement of MM.Brain metastases Other protocol-defined Inclusion/Exclusion criteria apply.

Restrictions found (4)

Recruiting in Massachusetts

  • Research Site · Boston, Suffolk County
  • Research Site · Boston, Suffolk County