Trial NCT05850234
AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)
- Phase
- Phase 1/2
- Sponsor
- AstraZeneca
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Ages
- 18+ years
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)
- Brain metastasesOutrightexclusionShow in the text
- CardiacConditionalexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0 or 1
Show in the text - Prior malignancyConditionalexclusion
disease-free < 2 years
Show in the text
Recruiting in Massachusetts
- Research Site · Boston, Suffolk County
- Research Site · Boston, Suffolk County