A Study to Evaluate Alnuctamab in Combination With Mezigdomide in Participants With Relapsed and/or Refractory Multiple Myeloma
Phase 1
Active, not recruiting
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT06163898
- Lead Sponsor
- Celgene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 156
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/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Arm B2 Dexamethasone - Arm C1 Alnuctamab - Arm B1 Alnuctamab - Arm B1 Mezigdomide - Arm C1 Mezigdomide - Part A Alnuctamab - Part A Mezigdomide - Part A Dexamethasone - Arm B1 Dexamethasone - Arm B2 Mezigdomide - Arm C1 Dexamethasone - Arm B2 Alnuctamab - Arm C2 Alnuctamab -
- Primary Outcome Measures
Name Time Method 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 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 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 Outcome Measures
Name Time Method 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) 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) 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) 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
Trial Locations
- Locations (6)
Local Institution - 0035
🇺🇸New Haven, Connecticut, United States
Local Institution - 0018
🇺🇸New York, New York, United States
Local Institution - 0033
🇺🇸Birmingham, Alabama, United States
Local Institution - 0020
🇮🇱Jerusalem, Israel
Local Institution - 0021
🇮🇱Petah-Tikva, HaMerkaz, Israel
Local Institution - 0030
🇮🇱Ramat Gan, HaMerkaz, Israel