Multiple Myeloma
Conditions
Brief summary
The purpose of this study is to determine the recommended dose and schedule, and evaluate the safety and preliminary efficacy of alnuctamab in combination with mezigdomide in participants with relapsed and/or refractory multiple myeloma.
Interventions
DRUGAlnuctamab
Specified dose on specified days
DRUGMezigdomide
Specified dose on specified days
DRUGDexamethasone
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participant has a history of RRMM, and must: * Part A: Have previously received ≥ 3 prior lines of anti-myeloma therapy. * Part B and Part C: Have received 1 to 3 prior lines of anti-myeloma therapy.
Exclusion criteria
• Must not have previously received alnuctamab or mezigdomide. Note: Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs) | 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) | — |
| Number of participants with serious AEs (SAEs) | 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) | — |
| Number of participants with AEs leading to discontinuation | 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) | — |
| Number of deaths | 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) | — |
| Number of participants with Dose-limiting toxicities (DLTs) | 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) | — |
| Overall Response Rate (ORR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate (CRR) | 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) | — |
| ORR | 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 |
| Very Good Partial Response Rate (VGPRR) | 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) | — |
| Progression-free Survival (PFS) | 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) | — |
| Time-to-Response (TTR) | 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) | — |
| Duration of Response (DOR) | 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) | — |
| Overall Survival (OS) | 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) | — |
Countries
Israel, United States
Outcome results
None listed