A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT06988488
- Lead Sponsor
- Celgene
- Brief Summary
The purpose of this study is to evaluate the preliminary safety and determine the RP2D of mezigdomide in combination with elranatamab in participants with relapsed and refractory multiple myeloma (RRMM).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 62
- Age ≥18 with history of relapsed and refractory multiple myeloma (RRMM) treated with 2 to 4 prior lines of anti-myeloma therapy (Phase 1) or 1 to 3 prior lines of anti-myeloma therapy (Phase 2).
- Measurable MM by local laboratory.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.
- Adherence to contraception requirements.
- Prior treatment with mezigdomide.
- Prior treatment with T cell engaging or T cell engager (TCE).
- Prior treatment with B cell-maturation antigen (BCMA)-targeting therapy, with the exception of participants who have received autologous BCMA-targeted CART-cell therapy> 6 months from the start of study therapy
- Other protocol-defined Inclusion/Exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 1 Elranatamab - Phase 1 Mezigdomide - Phase 1 Dexamethasone - Phase 2 Elranatamab - Phase 2 Mezigdomide - Phase 2 Dexamethasone -
- Primary Outcome Measures
Name Time Method Number of participants with Adverse Events (AEs) From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer Number of participants with Serious AEs From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer Number of participants with AEs meeting protocol-defined DLT criteria From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer Number of participants with AEs leading to discontinuation From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer Number of deaths From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer Recommended Phase 2 Dose (RP2D) From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)
- Secondary Outcome Measures
Name Time Method IMWG Uniform Response Criteria: 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 (At approximately 5 years) IMWG Uniform Response Criteria: 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 (At approximately 5 years) IMWG Uniform Response Criteria: 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 (At approximately 5 years) International Myeloma Working Group (IMWG) Uniform Response Criteria: 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 (At approximately 5 years) IMWG Uniform Response Criteria: 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 (At approximately 5 years) IMWG Uniform Response Criteria: 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 (At approximately 5 years) IMWG Uniform Response Criteria: 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 (At approximately 5 years) Number of participants who achieve minimal residual disease (MRD) negativity From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years) Defined as less than 1 in 10\^5 nucleated cells in BMA for participants who achieve CR or better at any time after enrollment
Trial Locations
- Locations (17)
Local Institution - 0001
🇺🇸Birmingham, Alabama, United States
Local Institution - 0029
🇺🇸New Haven, Connecticut, United States
Local Institution - 0028
🇺🇸Hackensack, New Jersey, United States
Local Institution - 0005
🇺🇸Houston, Texas, United States
Local Institution - 0024
🇨🇦Toronto, Ontario, Canada
Local Institution - 0015
🇩🇪Dresden, Germany
Local Institution - 0013
🇩🇪Hamburg, Germany
Local Institution - 0014
🇩🇪Heidelberg, Germany
Local Institution - 0011
🇬🇷Athens, Attikí, Greece
Local Institution - 0012
🇬🇷Athens, Attikí, Greece
Local Institution - 0017
🇳🇴Trondheim, Sør-Trøndelag, Norway
Local Institution - 0019
🇳🇴Oslo, Norway
Local Institution - 0021
🇪🇸Santander, Cantabria, Spain
Local Institution - 0022
🇪🇸Salamanca, Spain
Local Institution - 0016
🇬🇧London, England, United Kingdom
Local Institution - 0018
🇬🇧London, Sutton, United Kingdom
Local Institution - 0020
🇬🇧Manchester, United Kingdom