The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
850
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Progression-free survival (PFS) assessed by the Investigator
Time frame: Up to approximately 67 months
PFS assessed by the Investigator
Time frame: Up to approximately 67 months
Overall survival (OS)
Time frame: Up to approximately 67 months
Event-free survival (EFS)
Time frame: Up to approximately 67 months
Complete Metabolic Response assessed by the Independent Response Adjudication Committee (IRAC)
Time frame: Up to approximately 18 weeks
Minimal residual disease (MRD) negativity rate
Time frame: Up to approximately 18 weeks
Progression-free survival (PFS) assessed by the IRAC
Time frame: Up to approximately 47 months
Objective response (OR) assessed by the Investigator
Time frame: Up to approximately 18 weeks
Complete metabolic response (CMR) assessed by the Investigator
Time frame: Up to approximately 18 weeks
PFS24 assessed by the Investigator 24 months after randomization
Time frame: Up to 24 months
Duration of response (DoR)
Time frame: Up to approximately 67 months
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Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0014
Mobile, Alabama, United States
Local Institution - 0477
Anchorage, Alaska, United States
Local Institution - 0452
Phoenix, Arizona, United States
Local Institution - 0342
San Francisco, California, United States
Local Institution - 0497
Fort Myers, Florida, United States
Local Institution - 0287
Jacksonville, Florida, United States
Local Institution - 0415
Margate, Florida, United States
Local Institution - 0045
Miami Beach, Florida, United States
Local Institution - 0012
Pensacola, Florida, United States
Local Institution - 0502
St. Petersburg, Florida, United States
...and 315 more locations
Second progression-free survival (PFS2) assessed by the Investigator
Time frame: Up to approximately 67 months
Relative dose intensity (%)
Time frame: Up to 18 weeks
Time from randomization to meaningful improvement in primary domains of interest in the European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) Questionnaire
Time frame: Up to approximately 67 months
Time from randomization to meaningful improvement in primary domains of interest in the Functional Assessment of Cancer Treatment-Lymphoma (FACT-LymS) Questionnaire
Time frame: Up to approximately 67 months
Mean change from baseline in the EORTC QLQ-C30
Time frame: Up to approximately 67 months
Mean change from baseline in the FACT-LymS
Time frame: Up to approximately 67 months
Number of participants with Adverse Events (AEs)
Time frame: Up to approximately 20 weeks
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to approximately 20 weeks
Number of participants with laboratory abnormalities
Time frame: Up to approximately 20 weeks
Number of participants with vital sign abnormalities
Time frame: Up to approximately 20 weeks