Recruiting 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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Elranatamab, Mezigdomide, Dexamethasone.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, China, Germany, Greece +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Drug Elranatamab
Specified dose on specified days - Drug Mezigdomide
Specified dose on specified days - Drug Dexamethasone
Specified dose on specified days
Primary outcome measures
- Number of participants with Adverse Events (AEs) [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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 (8)
- International Myeloma Working Group (IMWG) Uniform Response Criteria: Overall Response Rate (ORR) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: 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)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- University of Alabama at Birmingham — Birmingham
- Yale New Haven Hospital-Smilow Cancer Center — New Haven
- Hackensack University Medical Center — Hackensack
- University of Texas MD Anderson Cancer Center — Houston
Canada · 4 centers
- Arthur J E Child Comprehensive Cancer Centre — Calgary
- Local Institution - 0026 — Vancouver
- QEII Health Sciences Centre - Victoria General Site — Halifax
- Princess Margaret Cancer Centre — Toronto
Germany · 3 centers
- Universitaetsklinikum Carl Gustav Carus Dresden — Dresden
- Universitaetsklinikum Hamburg-Eppendorf — Hamburg
- Universitaetsklinikum Heidelberg — Heidelberg
United Kingdom · 3 centers
- University College London Hospital — London
- Royal Marsden Hospital (Sutton) — London
- The Christie NHS Foundation Trust — Manchester
China · 2 centers
- Local Institution - 0030 — Suzhou
- Local Institution - 0031 — Shanghai
Greece · 2 centers
- Evangelismos General Hospital of Athens — Athens
- Alexandra General Hospital of Athens — Athens
Norway · 2 centers
- St. Olavs Hospital — Trondheim
- Sykehusapoteket Ull — Oslo
Spain · 2 centers
- Hospital Universitario Marqués de Valdecilla — Santander
- Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca — Salamanca
Identifiers
NCT: NCT06988488 · CA057-1040 · 2025-522090-11 · U1111-1317-4901