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Trial · NCT02545907

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With Dose-Limiting Toxicities as Assessed by Reported DataAfter 1 cycle of treatment; to be completed within 1 year.
Evaluable set- patient who received at least one cycle of the study treatment. KTD Patients who do not receive one complete cycle due to experiencing a DLT will be included in the analysis; patients who do not receive at least one complete cycle for reasons other than toxicity, without experiencing a DLT, and who miss a dose of Carfilzomib, more than 14 doses Thalidomide or 2 doses of Dexamethasone in the first cycle, will be replaced.
ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants Experiencing Grade 3 or 4 Toxicity as Assessed by CTCAE v4.0.Between informed consent provided and 30 days post last trial treatment administration, up to 7 monthsAll patients that receive at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYClonal Response Rate Within 3 Months, at 3 Months, Within 6 Months and at 6 Months as Determined by Paraprotein and Free Light Chain Assessment.Within 3 months, at 3 months, within 6 months and at 6 monthsParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYAmyloidotic Organ Response Rate Within 3 Months and 6 Months Based on Biochemical, Electrocardiographical, and Radiographical Assessment.Within 3 months and 6 monthsParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYTime to Amyloidotic Organ Response Based on Reported Data.Within 6 monthsParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Deaths at 6 Months Based on Reported Data.6 monthsParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Patients Progression-free at 6 Months Based on Reported Data.6 monthsParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYMaximum Response Determined by Paraprotein and Free Light Chain Assessment.Within 6 monthsParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYTime to Maximum Response Based on Reported Data.Within 6 monthsmonthsMEDIAN
SECONDARYNumber of Patients Withdrawing From Treatment Based on Reported Data.Within 6 monthsParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Patients Experiencing Dose Delays Based on Reported Data.Within 6 monthsParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYCompliance Profile of KTD Based on Reported Chemotherapy Compliance Data.Within 6 monthsParticipantsCOUNT_OF_PARTICIPANTS

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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