Multiple Myeloma Clinical Trial
Official title:
A Phase 1b/2a, Multicenter, Open-label Study 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
| Verified date | June 2024 |
| Source | Celgene |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 156 |
| Est. completion date | February 13, 2032 |
| Est. primary completion date | February 13, 2032 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Local Institution - 0020 | Jerusalem | |
| Israel | Local Institution - 0021 | Petah-Tikva | HaMerkaz |
| Israel | Local Institution - 0030 | Ramat Gan | HaMerkaz |
| United States | Local Institution - 0033 | Birmingham | Alabama |
| United States | Local Institution - 0035 | New Haven | Connecticut |
| United States | Local Institution - 0018 | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene |
United States, Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | ||
| Primary | 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) | ||
| Primary | 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) | ||
| Primary | 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) | ||
| Primary | 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) | ||
| Primary | Overall Response Rate (ORR) | Phase 2 only | 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) | |
| Secondary | 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) | ||
| Secondary | 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) | ||
| Secondary | 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) | ||
| Secondary | 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) | ||
| Secondary | 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) | ||
| Secondary | 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) | ||
| Secondary | ORR | Phase 1 only | 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) |
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