Multiple Myeloma
Conditions
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).
Interventions
DRUGElranatamab
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
* 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.
Exclusion criteria
* 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| 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) | — |
| 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 |
Countries
Canada, China, Germany, Greece, Norway, Spain, United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain the NCT# and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed