The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Progression-free Survival (PFS)
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 5 years
Overall response (OR)
Time frame: Up to 5 years
Complete response (CR) or better
Time frame: Up to 5 years
Very good partial response (VGPR) or better
Time frame: Up to 5 years
Time to response (TTR)
Time frame: Up to 5 years
Duration of response (DOR)
Time frame: Up to 5 years
Time to progression (TTP)
Time frame: Up to 5 years
Time to next treatment (TTNT)
Time frame: Up to 5 years
Progression-free survival 2 (PFS2)
Time frame: Up to 5 years
Restricted mean DOR (RMDOR)
Time frame: Up to 5 years
Minimal residual disease (MRD) negativity rate
Time frame: Up to 5 years
Incidence of adverse events (AEs)
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Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0151
Birmingham, Alabama, United States
Local Institution - 0088
Los Angeles, California, United States
Local Institution - 0358
Stanford, California, United States
Local Institution - 0355
New Haven, Connecticut, United States
Local Institution - 0434
Washington D.C., District of Columbia, United States
Local Institution - 0433
Wichita, Kansas, United States
Local Institution - 0439
Saint Matthews, Kentucky, United States
Local Institution - 0323
New Orleans, Louisiana, United States
Local Institution - 0324
Baltimore, Maryland, United States
Local Institution - 0441
Bethesda, Maryland, United States
...and 160 more locations
Time frame: Up to 5 years
Incidence of serious adverse events (SAEs)
Time frame: Up to 5 years
Change from baseline in subscale scores of European organization for research and treatment of cancer - quality of life core 30 (EORTC QLQ-C30)
Time frame: Up to 5 years
Change from baseline in subscale scores of European quality of life multiple myeloma module (EORTC QLQ-MY20)
Time frame: Up to 5 years