Trial comparing treatments for Relapsed Refractory Multiple Myeloma
Official title A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)
ClinicalTrials.gov ID: NCT07391657
What this study is testing
What is AZD0120?
AZD0120 is an investigational CAR‑T cell therapy being studied for relapsed refractory 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 study is testing whether AZD0120 works better and is safe compared to standard treatment regimens.
- Who it's for
- You may be able to join if you have relapsed refractory multiple myeloma.
- What's involved
- You will receive a single infusion of AZD0120 or one of the standard medicine combos. You will have doctor visits and tests to see how well it works and how safe it is.
- Time commitment
- The study lasts several months with regular check‑in visits.
- 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
- Age ≥ 18 years
- Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria
- Serum M-protein level ≥ 1 g/dL
- Urine M-protein level ≥ 200 mg/24h
- Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio
You likely can't join if
- Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.
- Primary amyloidosis, active plasma cell leukaemia, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin...
- Participants with primary refractory MM (failed to generate at least a minimal response to any prior therapy)
- Significant neurological or psychiatric condition
- Significant medical condition that places the participant at an unacceptable risk for treatment-related complications
- Previously received any prior BCMA-targeted treatment
See the full eligibility criteria
- Age ≥ 18 years
- Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria
- Serum M-protein level ≥ 1 g/dL
- Urine M-protein level ≥ 200 mg/24h
- Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio
- Documented evidence of PD by IMWG 2016 criteria based on investigator's determination during or after the most recent line of therapy.
- Received 1 to 3 lines of prior therapy including an IMiD and either a PI or a CD38 antibody. Participant must have undergone at least 2 complete cycles of treatment for each line of therapy, unless PD was the best...
- Eligible to receive at least one of the standard regimens (DKd, PVd, DPd, or Kd) as determined by the Investigator.
- ECOG performance status score of 0 to 1
- Haemoglobin ≥ 8.0 g/dL
- Absolute neutrophil count ≥ 1 × 10\^9/L (1000 per mm3)
- Platelet count ≥ 75 × 10\^9/L (75000 per mm3) in participants with \< 50% of bone marrow nucleated cells are plasma cells or ≥ 50 × 10\^9/L (50000 per mm3) in participants with ≥ 50% of bone marrow nucleated cells are...
- Absolute lymphocyte count ≥ 300/µL (0.3 × 109/L)
- Total bilirubin ≤ 1.5 × ULN in the absence of Gilbert's syndrome or ≤ 3 × ULN if the participant has Gilbert's syndrome. AST and ALT≤ 3.0 × ULN. CrCl by Cockcroft and Gault method ≥ 30 mL/minute
- Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.
- Primary amyloidosis, active plasma cell leukaemia, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome.
- Participants with primary refractory MM (failed to generate at least a minimal response to any prior therapy)
- Significant neurological or psychiatric condition
- Significant medical condition that places the participant at an unacceptable risk for treatment-related complications
- Previously received any prior BCMA-targeted treatment
- Previously received CAR-T or CAR-NK therapy directed at any target
- Previously received T-cell engager therapy directed at any target
- Previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of randomization
The study team makes the final eligibility decision.
Where it is enrolling
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Atlanta, Georgia, United States
- Louisville, Kentucky, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
- Camperdown, Australia
- Darlinghurst, Australia
- Fitzroy, Australia
- Melbourne, Australia
- Salvador, Brazil
- São Paulo, Brazil
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
+ 15 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, but 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?
This study is enrolling now at Denver, Colorado, United States; New Haven, Connecticut, United States; Atlanta, Georgia, United States; Louisville, Kentucky, United States; New York, New York, United States; Charlotte, North Carolina, United States and 29 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.