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Tests treatment safety and results for Multiple Myeloma
Official title A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120 in Participants With Multiple Myeloma (DURGA-2)
ClinicalTrials.gov ID: NCT07073547
What this study is testing
What is AZD0120?
AZD0120 is an investigational medicine, being studied as a potential treatment for multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an interventional, modular, open-label, multicenter study to primarily evaluate the safety and tolerability of AZD0120 in adult participants with multiple myeloma (MM).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age:
- Males and females ≥18 years of age at the time of consent Type of Participant and Disease Characteristics:
- Participant must have documented diagnosis of MM per IMWG diagnostic criteria
- ECOG performance status of 0 or 1.
- Adequate organ and bone marrow function. For NDMM participants:
You likely can't join if
- Have received prior treatment with CAR T therapy directed at any target
- Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
- Active or history of plasma cell leukemia at the time of screening
- Seropositive for human immunodeficiency virus (HIV)
- Active Hepatitis B infection
- Active Hepatitis C infection
See the full eligibility criteria
- Age:
- Males and females ≥18 years of age at the time of consent Type of Participant and Disease Characteristics:
- Participant must have documented diagnosis of MM per IMWG diagnostic criteria
- ECOG performance status of 0 or 1.
- Adequate organ and bone marrow function. For NDMM participants:
- Participants on Module 1: Newly diagnosed multiple myeloma (NDMM) without prior anti- myeloma therapy (no more than 2 cycles of induction therapy before enrollment are acceptable)
- For participants on Module 2: Newly diagnosed MM with a minimum of 4 cycles and a maximum of 6 cycles of induction therapy completed prior to screening
- Classified as high-risk MM For Early Relapsed or Primary Refractory MM (1 or 2 prior lines of therapy) participants:
- Have received and failed 1 or 2 lines of anti-myeloma therapy
- Have received a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) as part of their previous therapy
- Have documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria within 1 year of starting treatment, or on or within 6 months of completing treatment of the...
- Have received prior treatment with CAR T therapy directed at any target
- Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
- Active or history of plasma cell leukemia at the time of screening
- Seropositive for human immunodeficiency virus (HIV)
- Active Hepatitis B infection
- Active Hepatitis C infection
- Serious underlying medical condition
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Duarte, California, United States
- Denver, Colorado, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Iowa City, Iowa, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Duarte, California, United States; Denver, Colorado, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Iowa City, Iowa, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.