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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
508
CAR-T Cells
Daratumumab
Carfilzomib
Dexamethasone
Bortezomib
Pomalidomides
Research Site
Gilbert, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Phoenix, Arizona, United States
WITHDRAWNResearch Site
Tucson, Arizona, United States
NOT_YET_RECRUITINGResearch Site
La Jolla, California, United States
WITHDRAWNTo 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
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
AstraZeneca Clinical Study Information Center
CONTACT
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Research Site
Sacramento, California, United States
NOT_YET_RECRUITINGResearch Site
Santa Monica, California, United States
NOT_YET_RECRUITINGResearch Site
Denver, Colorado, United States
RECRUITINGResearch Site
New Haven, Connecticut, United States
RECRUITINGResearch Site
Washington D.C., District of Columbia, United States
NOT_YET_RECRUITINGResearch Site
Coral Gables, Florida, United States
WITHDRAWN...and 133 more locations