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.
Summary
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.
Arms & interventions
- BiologicalAZD0120
CAR-T Cells
- DrugDaratumumab
Daratumumab
- DrugCarfilzomib
Carfilzomib
- DrugDexamethasone
Dexamethasone
- DrugBortezomib
Bortezomib
- DrugPomalidomide
Pomalidomides
Outcome measures
Primary
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.
Time frame: 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.
Time frame: 2 years
Secondary
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of CRR in participants with RRMM.
Time frame: 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.
Time frame: 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.
Time frame: 5 years
Eligibility criteria
Study locations (48)
Research Site
Gilbert, Arizona, 85234
Research Site
Phoenix, Arizona, 85054
Research Site
Tucson, Arizona, 85719
Research Site
La Jolla, California, 92093
Research Site
Sacramento, California, 95817
Research Site
Santa Monica, California, 90404
Research Site
Denver, Colorado, 80218
Research Site
New Haven, Connecticut, 06510
Research Site
Washington D.C., District of Columbia, 20007
Research Site
Coral Gables, Florida, 33156
Research Site
Tampa, Florida, 33606
Research Site
Atlanta, Georgia, 30322
Research Site
Chicago, Illinois, 60612
Research Site
Park Ridge, Illinois, 60068
Research Site
Iowa City, Iowa, 52242
Research Site
Kansas City, Kansas, 66160
Research Site
Louisville, Kentucky, 40207
Research Site
Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02215
Research Site
Boston, Massachusetts, 02215
Research Site
Detroit, Michigan, 48201
Research Site
Detroit, Michigan, 48202
Research Site
Rochester, Minnesota, 55905
Research Site
Albany, New York, 12208
Research Site
New York, New York, 10016
Research Site
New York, New York, 10029
Research Site
New York, New York, 10065
Research Site
New York, New York, 10065
Research Site
Rochester, New York, 14642
Research Site
The Bronx, New York, 10467
Research Site
Chapel Hill, North Carolina, 27514
Research Site
Charlotte, North Carolina, 28204
Research Site
Winston-Salem, North Carolina, 27103
Research Site
Cincinnati, Ohio, 45220
Research Site
Cleveland, Ohio, 44195
Research Site
Portland, Oregon, 97239
Research Site
Charleston, South Carolina, 29425
Research Site
Nashville, Tennessee, 37203
Research Site
Austin, Texas, 78704
Research Site
Dallas, Texas, 75235
Research Site
Houston, Texas, 77030
Research Site
Salt Lake City, Utah, 84112
Research Site
Charlottesville, Virginia, 22908
Research Site
Gainesville, Virginia, 20155
Research Site
Richmond, Virginia, 23298
Research Site
Seattle, Washington, 98104
Research Site
Madison, Wisconsin, 53792
Research Site
Milwaukee, Wisconsin, 53226