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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.
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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

Reclutando
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El ensayo clínico NCT07391657 (DURGA-4) está diseñado para estudiar el tratamiento de Mieloma múltiple en recaída/refractario. Es un estudio intervencionista de Fase III. Su estado actual es: reclutando. El estudio se inició el 23 de febrero de 2026, con el objetivo de reclutar a 508 participantes. Dirigido por AstraZeneca, se espera que finalice el 29 de julio de 2030. Los datos se actualizaron por última vez en ClinicalTrials.gov el 12 de marzo de 2026.
Resumen
This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of AZD0120 versus standard regimens (DKd \[daratumumab, carfilzomib, and dexamethasone\], DPd \[daratumumab, pomalidomide, and dexamethasone\], PVd \[pomalidomide, bortezomib and dexamethasone\], or Kd \[carfilzomib and dexamethasone\]) in participants with RRMM.
Título oficial

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.

Condiciones médicas
Mieloma múltiple en recaída/refractario
Otros ID del estudio
  • DURGA-4
  • D8311C00001
  • AZD0120 (Otro identificador) (AstraZeneca)
Número del NCT
Inicio del estudio (real)
2026-02-23
Última actualización
2026-03-12
Fecha de finalización (estimada)
2030-07-29
Inscripción (prevista)
508
Tipo de estudio
Intervencionista
FASE
Fase III
Estado general
Reclutando
Palabras clave
BCMA
CAR-T
CD19
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/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
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo 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
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo 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
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  • Age ≥ 18 years

  • Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria

  • Documented evidence of measurable disease:

    1. Serum M-protein level ≥ 1 g/dL
    2. Urine M-protein level ≥ 200 mg/24h
    3. 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:

    1. Haemoglobin ≥ 8.0 g/dL
    2. Absolute neutrophil count ≥ 1 × 10^9/L (1000 per mm3)
    3. 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
    4. Absolute lymphocyte count ≥ 300/µL (0.3 × 109/L)
    5. 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
AstraZeneca logoAstraZeneca
Contactos centrales del estudio
Contacto: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
108 Centros del estudio en 14 países
Research Site, Barcelona, 08036, Spain
Aún no recluta
Research Site, Barcelona, 8035, Spain
Aún no recluta
Research Site, Madrid, 28041, Spain
Aún no recluta
Research Site, Pamplona, 31008, Spain
Aún no recluta
Research Site, Salamanca, 37007, Spain
Aún no recluta
Research Site, Santander, 39008, Spain
Aún no recluta
Research Site, Valencia, 46026, Spain
Aún no recluta

Arizona

Research Site, Gilbert, Arizona, 85234, United States
Aún no recluta
Research Site, Phoenix, Arizona, 85054, United States
Aún no recluta
Research Site, Tucson, Arizona, 85719, United States
Aún no recluta

California

Research Site, La Jolla, California, 92093, United States
Retirado
Research Site, Santa Monica, California, 90404, United States
Aún no recluta

Colorado

Research Site, Denver, Colorado, 80218, United States
Aún no recluta

Connecticut

Research Site, New Haven, Connecticut, 06510, United States
Aún no recluta

District of Columbia

Research Site, Washington D.C., District of Columbia, 20007, United States
Aún no recluta

Georgia

Research Site, Atlanta, Georgia, 30322, United States
Aún no recluta

Illinois

Research Site, Chicago, Illinois, 60612, United States
Aún no recluta
Research Site, Park Ridge, Illinois, 60068, United States
Aún no recluta

Iowa

Research Site, Iowa City, Iowa, 52242, United States
Retirado

Kansas

Research Site, Kansas City, Kansas, 66160, United States
Aún no recluta

Kentucky

Research Site, Louisville, Kentucky, 40207, United States
Aún no recluta

Massachusetts

Research Site, Boston, Massachusetts, 02114, United States
Aún no recluta
Research Site, Boston, Massachusetts, 02215, United States
Aún no recluta
Research Site, Boston, Massachusetts, 02215, United States
Retirado

Michigan

Research Site, Detroit, Michigan, 48202, United States
Retirado

Minnesota

Research Site, Rochester, Minnesota, 55905, United States
Aún no recluta

New York

Research Site, New York, New York, 10016, United States
Retirado
Research Site, New York, New York, 10029, United States
Aún no recluta
Research Site, New York, New York, 10065, United States
Aún no recluta
Research Site, Rochester, New York, 14642, United States
Retirado
Research Site, The Bronx, New York, 10467, United States
Retirado

North Carolina

Research Site, Chapel Hill, North Carolina, 27514, United States
Aún no recluta
Research Site, Charlotte, North Carolina, 28204, United States
Aún no recluta
Research Site, Winston-Salem, North Carolina, 27103, United States
Aún no recluta

Ohio

Research Site, Cincinnati, Ohio, 45220, United States
Aún no recluta
Research Site, Cleveland, Ohio, 44195, United States
Aún no recluta

Oregon

Research Site, Portland, Oregon, 97239, United States
Aún no recluta

South Carolina

Research Site, Charleston, South Carolina, 29425, United States
Retirado

Tennessee

Research Site, Nashville, Tennessee, 37203, United States
Aún no recluta

Texas

Research Site, Austin, Texas, 78704, United States
Aún no recluta
Research Site, Dallas, Texas, 75235, United States
Aún no recluta
Research Site, Houston, Texas, 77030, United States
Aún no recluta

Utah

Research Site, Salt Lake City, Utah, 84112, United States
Aún no recluta

Virginia

Research Site, Charlottesville, Virginia, 22908, United States
Retirado
Research Site, Richmond, Virginia, 23298, United States
Retirado

Washington

Research Site, Seattle, Washington, 98104, United States
Aún no recluta

Wisconsin

Research Site, Madison, Wisconsin, 53792, United States
Aún no recluta
Research Site, Milwaukee, Wisconsin, 53226, United States
Aún no recluta
Research Site, Camperdown, 2050, Australia
Aún no recluta
Research Site, Darlinghurst, 2010, Australia
Aún no recluta
Research Site, Fitzroy, VIC3065, Australia
Reclutando
Research Site, Liverpool, 2170, Australia
Aún no recluta
Research Site, Melbourne, 3000, Australia
Aún no recluta
Research Site, Melbourne, 3004, Australia
Aún no recluta
Research Site, Murdoch, WA6150, Australia
Aún no recluta
Research Site, Salvador, 41253-190, Brazil
Aún no recluta
Research Site, São Paulo, 01509-900, Brazil
Aún no recluta
Research Site, São Paulo, 05652-900, Brazil
Aún no recluta

Alberta

Research Site, Calgary, Alberta, T2N 5G2, Canada
Aún no recluta

British Columbia

Research Site, Vancouver, British Columbia, V5Z 4E6, Canada
Aún no recluta

Ontario

Research Site, Toronto, Ontario, M5G 2M9, Canada
Aún no recluta

Quebec

Research Site, Montreal, Quebec, H3A 1A1, Canada
Aún no recluta
Research Site, Lille, 59037, France
Aún no recluta
Research Site, Nantes, 44093, France
Aún no recluta
Research Site, Paris, 75010, France
Aún no recluta
Research Site, Pierre-Bénite, 69495, France
Aún no recluta
Research Site, Poitiers, 86021, France
Aún no recluta
Research Site, Toulouse, 31059, France
Aún no recluta
Research Site, Berlin, 12200, Germany
Aún no recluta
Research Site, Dresden, 01307, Germany
Aún no recluta
Research Site, Erlangen, 91054, Germany
Aún no recluta
Research Site, Essen, 45147, Germany
Aún no recluta
Research Site, Freiburg im Breisgau, 79106, Germany
Aún no recluta
Research Site, Hamburg, 20246, Germany
Aún no recluta
Research Site, Leipzig, 04103, Germany
Aún no recluta
Research Site, Mainz, 55131, Germany
Aún no recluta
Research Site, Nuremberg, 90419, Germany
Aún no recluta
Research Site, Würzburg, 97080, Germany
Aún no recluta
Research Site, Bologna, 40138, Italy
Aún no recluta
Research Site, Milan, 20132, Italy
Aún no recluta
Research Site, Milan, 20133, Italy
Aún no recluta
Research Site, Naples, 80131, Italy
Aún no recluta
Research Site, Rozzano, 20089, Italy
Aún no recluta
Research Site, Torino, 10126, Italy
Aún no recluta
Research Site, Bunkyō City, 113-8431, Japan
Aún no recluta
Research Site, Kashiwa, 277-8577, Japan
Aún no recluta
Research Site, Kyoto, 602-8566, Japan
Aún no recluta
Research Site, Nagoya, 467-8602, Japan
Aún no recluta
Research Site, Shibuya-ku, 150-8935, Japan
Aún no recluta
Research Site, Shinjuku-ku, 160-8582, Japan
Aún no recluta
Research Site, Oslo, 0450, Norway
Aún no recluta
Research Site, Gdansk, 80-952, Poland
Aún no recluta
Research Site, Gliwice, 44-101, Poland
Aún no recluta
Research Site, Lublin, 20-090, Poland
Aún no recluta
Research Site, Poznan, 60-569, Poland
Aún no recluta
Research Site, Warsaw, 02-776, Poland
Aún no recluta
Research Site, Wroclaw, 50-367, Poland
Aún no recluta
Research Site, Seoul, 03080, South Korea
Aún no recluta
Research Site, Seoul, 06351, South Korea
Aún no recluta
Research Site, Seoul, 06591, South Korea
Aún no recluta
Research Site, Seoul, 5505, South Korea
Aún no recluta
Research Site, Taipei, 10002, Taiwan
Aún no recluta
Research Site, Taipei, 106, Taiwan
Aún no recluta
Research Site, Taipei, 112, Taiwan
Aún no recluta
Research Site, Birmingham, B9 5SS, United Kingdom
Aún no recluta
Research Site, Bristol, BS2 8ED, United Kingdom
Aún no recluta
Research Site, Glasgow, Scotland, G12 0YN, United Kingdom
Aún no recluta
Research Site, London, SM2 5NG, United Kingdom
Aún no recluta