Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Kontakt
BMS Study Connect Contact Center www.BMSStudyConnect.com Kontakt: Phone: 855-907-3286 E-Mail: Clinical.Trials@bms.com» Kontaktdaten anzeigen First line of the email MUST contain the NCT# and Site #.
1. Number of participants with adverse events (AEs) (Time Frame - Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years))
2. Number of participants with serious AEs (SAEs) (Time Frame - Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years))
3. Number of participants with AEs leading to discontinuation (Time Frame - Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years))
4. Number of deaths (Time Frame - Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years))
5. Number of participants with Dose-limiting toxicities (DLTs) (Time Frame - Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years))
6. Overall Response Rate (ORR) (Time Frame - From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)): Phase 2 only
Secondary outcome:
1. Complete Response Rate (CRR) (Time Frame - From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years))
2. Very Good Partial Response Rate (VGPRR) (Time Frame - From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years))
3. Progression-free Survival (PFS) (Time Frame - From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years))
4. Time-to-Response (TTR) (Time Frame - From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years))
5. Duration of Response (DOR) (Time Frame - From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years))
6. Overall Survival (OS) (Time Frame - From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years))
7. ORR (Time Frame - From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)): Phase 1 only
