IA Trial Radar | ||
|---|---|---|
El ensayo clínico NCT07391657 (DURGA-4) para Mieloma múltiple en recaída/refractario está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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) Fase III 508 Etiqueta abierta
A Phase III Open-label, Randomised, Multicentre Study Comparing AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CART) Therapy Directed Against BCMA and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma.
- DURGA-4
- D8311C00001
- AZD0120 (Otro identificador) (AstraZeneca)
CAR-T
CD19
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalArm A AZD0120 | AZD0120 CAR-T Cells |
Comparador activoArm B 1 of the following 4 standard regimens per investigator choice; DKd, DPd, PVd, Kd. | Daratumumab Daratumumab Carfilzomib Carfilzomib Dexamethasone Dexamethasone Bortezomib Bortezomib Pomalidomide Pomalidomides |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of PFS in participants with RRMM. | PFS: defined as time from randomisation until progression according to IMWG 2016 criteria as assessed by BICR, or death due to any cause, whichever occurs first. | 3 years |
To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of MRD negativity rate at 9 months in participants with RRMM. | MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status and have a response of CR or sCR (according to the IMWG 2016 criteria) at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy. | 2 years |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of CRR in participants with RRMM. | 2 years | |
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of ORR in participants with RRMM. | 2 years | |
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of OS in participants with RRMM. | 5 years |
Age ≥ 18 years
Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria
Documented evidence of measurable disease:
- 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. Participants with only 1 prior line of therapy must have progressed within 47 months of a stem cell transplant, or if not transplanted, then within 42 months of starting initial 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 response to the line of therapy
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
Adequate hematology and chemistry laboratory values:
- 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 plasma cells
- 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
Arizona
California
Colorado
Connecticut
District of Columbia
Georgia
Illinois
Iowa
Kansas
Kentucky
Massachusetts
Michigan
Minnesota
New York
North Carolina
Ohio
Oregon
South Carolina
Tennessee
Texas
Utah
Virginia
Washington
Wisconsin
Alberta
British Columbia
Ontario
Quebec