Clinical trial NCT06988488: 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
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 Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2025-05-25
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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/Exclusion criteria apply.

Primary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
measure: Number of participants with Serious AEs
timeFrame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
measure: Number of participants with AEs meeting protocol-defined DLT criteria
timeFrame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
measure: Number of participants with AEs leading to discontinuation
timeFrame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
measure: Number of deaths
timeFrame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer
measure: Recommended Phase 2 Dose (RP2D)
timeFrame: 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 outcomes:
measure: International Myeloma Working Group (IMWG) Uniform Response Criteria: Overall Response Rate (ORR)
timeFrame: 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)
measure: IMWG Uniform Response Criteria: Complete Response Rate (CRR)
timeFrame: 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)
measure: IMWG Uniform Response Criteria: Very Good Partial Response Rate (VGPRR)
timeFrame: 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)
measure: IMWG Uniform Response Criteria: Time to Response (TTR)
timeFrame: 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)
measure: IMWG Uniform Response Criteria: Duration of Response (DOR)
timeFrame: 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)
measure: IMWG Uniform Response Criteria: Progression-free Survival (PFS)
timeFrame: 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)
measure: IMWG Uniform Response Criteria: Overall Survival (OS)
timeFrame: 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)
measure: Number of participants who achieve minimal residual disease (MRD) negativity
timeFrame: 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)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0001
state: Alabama
city: New Haven
country: United States
facility: Local Institution - 0029
state: Connecticut
city: Hackensack
country: United States
facility: Local Institution - 0028
state: New Jersey
city: Houston
country: United States
facility: Local Institution - 0005
state: Texas
city: Vancouver
country: Canada
facility: Local Institution - 0026
state: British Columbia
city: Toronto
country: Canada
facility: Local Institution - 0024
state: Ontario
city: Suzhou
country: China
facility: Local Institution - 0030
state: Jiangsu
city: Shanghai
country: China
facility: Local Institution - 0031
state: Shanghai
city: Dresden
country: Germany
facility: Local Institution - 0015
city: Hamburg
country: Germany
facility: Local Institution - 0013
city: Heidelberg
country: Germany
facility: Local Institution - 0014
city: Athens
country: Greece
facility: Local Institution - 0011
state: Attikí
city: Athens
country: Greece
facility: Local Institution - 0012
state: Attikí
city: Trondheim
country: Norway
facility: Local Institution - 0017
state: Sør-Trøndelag
city: Oslo
country: Norway
facility: Local Institution - 0019
city: Santander
country: Spain
facility: Local Institution - 0021
state: Cantabria
city: Salamanca
country: Spain
facility: Local Institution - 0022
city: London
country: United Kingdom
facility: Local Institution - 0016
state: England
city: London
country: United Kingdom
facility: Local Institution - 0018
state: Sutton
city: Manchester
country: United Kingdom
facility: Local Institution - 0020
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: