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Trial · NCT07555938

Registered outcomes30

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

ListOutcomeTime frameDescription
PrimaryMinimal Residual Disease (MRD)-Negative Complete Response (CR) RateUp to 1 year after the last participant is randomized
PrimaryProgression-Free Survival (PFS)Up to 5 years after the last participant is randomized
SecondaryVery Good Partial Response (VGPR) or Better RateUp to 5 years after the last participant is randomized
SecondaryOverall Survival (OS)Up to 5 years after the last participant is randomized
SecondaryChange in Disease Symptoms as Assessed by the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Multiple Myeloma Module 20 (MY20)From baseline to Month 6Primary domains: fatigue, pain, physical functioning, cognitive functioning and global health status.
SecondaryOverall Response Rate (ORR)Up to 5 years after the last participant is randomized
SecondaryComplete Response (CR) RateUp to 5 years after the last participant is randomized
SecondaryTime to Response (TTR)Up to 5 years after the last participant is randomized
SecondaryTime to Best Response (TTBR)Up to 5 years after the last participant is randomized
SecondaryDuration of Response (DOR)Up to 5 years after the last participant is randomized
SecondaryProgression-Free Survival (PFS)Up to 5 years after the last participant is randomized
SecondaryProgression-Free Survival 2 (PFS2)Up to 5 years after the last participant is randomized
SecondaryOverall MRD-Negative Complete Response RateUp to 5 years after the last participant is randomized
SecondaryOverall MRD-Negative RateUp to 5 years after the last participant is randomized
SecondarySustained MRD-Negative CR RateAt 6, 12, and 24 months
SecondaryPercentage of Participants With Adverse Events (AEs)Up to 5 years after the last participant is randomized
SecondaryTolerability as Assessed by the Incidence of Dose Interruptions, Dose Reductions, Dose Intensity, and Treatment DiscontinuationUp to 5 years after the last participant is randomized
Secondary
Number of Participants With Presence, Frequency of Occurrence, Severity, and/or Degree of Interference With Daily Function of Shortness of Breath, Cough, Heart Palpitations, Rash, Dizziness, and Nausea Assessed NCI PRO-CTCAE
Up to 5 years after the last participant is randomized
Secondary
Change From Baseline in Shortness of Breath, Cough, Heart Palpitations, Rash, Dizziness, and Nausea Assessed by the National Cancer Institute Patient Reported Outcomes Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)
Baseline and up to 5 years after the last participant is randomized
SecondaryChange From Cycle 1 Day 8 in Treatment-Related Side Effect Bother as Assessed by the Functional Assessment of Cancer Therapy-General, General Population 5 (FACTG GP5)At Day 8 of Cycle 1, up to 5 years after the last participant is randomized. Cycle 1 is 21 days.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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