Clinical trial for Newly Diagnosed Multiple Myeloma
Official title Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT
ClinicalTrials.gov ID: NCT07764978
What this study is testing
What is AZD0120?
AZD0120 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for newly diagnosed 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 a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of standard induction regimens (IsaVRd and DRd) followed by AZD0120 versus standard induction regimens followed by continuous therapy (IsaRd and DRd) in participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT) as initial therapy.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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
- Participants must be 18 years or older, at the time of signing the ICF.
- Participant must have documented diagnosis of MM according to the IMWG diagnostic criteria.
- 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...
- Participant must be deemed ineligible for ASCT while also having adequate organ function for CAR-T cell treatment.
- Participant is a candidate to receive at least one of the regimens (IsaVRd or DRd) as determined by the Investigator.
You likely can't join if
- Participant has active or prior CNS or meningeal involvement of MM.
- Participant has primary amyloidosis, active plasma cell leukemia (≥5% circulating plasma cells), Waldenström macroglobulinemia, or POEMS syndrome.
- Participant has significant neurological or psychiatric condition posing risk or impairing evaluation.
- Participant has any other significant medical condition that increases unacceptable risk, interferes with therapy delivery, or confounds evaluation.
- Participant has a history of a prior non-haematologic malignancy unless the participant has been disease-free with no evidence of recurrence for ≥ 2...
- Participant has a history of haematologic malignancies, other than MM, regardless of remission status.
See the full eligibility criteria
- Participants must be 18 years or older, at the time of signing the ICF.
- Participant must have documented diagnosis of MM according to the IMWG diagnostic criteria.
- 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...
- Participant must be deemed ineligible for ASCT while also having adequate organ function for CAR-T cell treatment.
- Participant is a candidate to receive at least one of the regimens (IsaVRd or DRd) as determined by the Investigator.
- ECOG performance status Grade of 0 to 2.
- Participant must have adequate organ and bone marrow function.
- Participant has active or prior CNS or meningeal involvement of MM.
- Participant has primary amyloidosis, active plasma cell leukemia (≥5% circulating plasma cells), Waldenström macroglobulinemia, or POEMS syndrome.
- Participant has significant neurological or psychiatric condition posing risk or impairing evaluation.
- Participant has any other significant medical condition that increases unacceptable risk, interferes with therapy delivery, or confounds evaluation.
- 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.
- Participant has a history of haematologic malignancies, other than MM, regardless of remission status.
- Participant is positive for any of the following:
- HIV: Known to be seropositive for HIV (including any history of HIV).
- Chronic or active hepatitis B.
- Active hepatitis C: Hepatitis C infection.
- Additional local requirements for the testing for infectious diseases and exclusions of applicable participants should be followed per local regulations.
- Participant has clinically significant cardiovascular disease.
- Participant has COPD with an FEV1 \< 50% of predicted normal.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Orange, California, United States
- Santa Monica, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Coral Gables, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Wichita, Kansas, United States
- Louisville, Kentucky, United States
- Baton Rouge, Louisiana, United States
- Baltimore, Maryland, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- East Brunswick, New Jersey, United States
+ 90 more site(s).
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 Gilbert, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Orange, California, United States; Santa Monica, California, United States; Aurora, Colorado, United States and 104 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.