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Trial · NCT07348393

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryDetermine the progression-free survival (PFS) of mezigdomide, carfilzomib and dexamethasone (480Kd) in participants with relapsed or refractory multiple myeloma (RRMM)2 years
PFS defined as the time from inclusion to first documentation of progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma or death due to any cause, whichever occurs first.
SecondaryOverall Survival (OS)At 2-yearsDefined as the time from inclusion to time of death due to any cause
SecondaryBest overall Response Rate (ORR)2 yearsDefined as the percentage of participants who achieve best response of partial response (PR) or better according to the IMWG Uniform Response Criteria for Multiple Myeloma
SecondaryRate of very good partial response (VGPR) or better (VGPRR)2 yearsDefined as the percentage of participants who achieve best response of VGPR or better according to the IMWG Uniform Response Criteria for Multiple Myeloma
SecondaryRate of complete response (CR) or better (CRR)2 yearsDefined as the percentage of participants who achieve best response of CR or better according to the IMWG Uniform Response Criteria for Multiple Myeloma
SecondaryTime to Response (TTR)2 yearsDefined as the time from inclusion on to the first documentation of response (PR or better)
SecondaryDuration of Response (DOR)2 yearsDefined as the time from the first documentation of response (PR or better) to the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first
SecondaryTime to Progression (TTP)2 yearsDefined as the time from inclusion to the first documentation of PD
SecondaryTime to Next Treatment (TTNT)2 yearsDefined as the time from inclusion to the start of the next anti-myeloma treatment
SecondaryTo evaluate minimal residual disease (MRD) negativity rate in participants treated with 480Kd2 yearsthe proportion of participants who achieve CR or better and are MRD negative (defined at a sensitivity of a minimum of 1 in 105 nucleated cells)
SecondaryTo evaluate safety of 480Kd in participants with RRMM2 yearsDefined as the type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment
SecondaryTo evaluate cancer and multiple myeloma-related symptoms2 years
Using the European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30) and the European Quality of Life Multiple Myeloma module (EORTC QLQ-MY20) in participants treated with 480Kd
SecondaryTo evaluate health-related quality of life (HRQoL)2 yearsUsing HRQoL questionnaire

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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