Trial · NCT05344833
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants that have MRD-negative CR rate, defined as 10-6 | 1 year | Evaluate the number of participants that have MRD-negative at 1 year that were MRD-positive multiple myeloma (MM) treated with isatuximab and lenalidomide based maintenance after ASCT |
| Secondary | Observed length of time of progressive free survival (PFS) | 3 years | Number of days participants remain PFS |
| Secondary | Observed length of time of overall survival (OS) | 3 years | Number of days participants remain OS |
| Secondary | Number of participants that achieve a deeper MRD-negative CR rate, defined as 10-6 | 1 year | Evaluate the number of participants that achieve a deeper MRD-negative at 1 year that were MRD-positive in MM treated with isatuximab and lenalidomide based maintenance after ASCT |
| Secondary | Number of participants that convert from MRD-positive to MRD-negative disease status in MM patients | 3 years | Evaluate number of participants that convert from MRD-positive to MRD-negative disease status in MM patients receiving isatuximab and lenalidomide based maintenance |
| Secondary | Number of participants that have an International Myeloma Working Group (IMWG) defined response rate of MM patients receiving isatuximab and lenalidomide based maintenance | 3 years | Evaluate the number of participants that have an IMWG defined response rate |
| Secondary | Number of participants that have MRD-negative CR rates of MM patients receiving isatuximab and lenalidomide based maintenance | 3 years | Evaluate the number of participants that have MRD-negative CR rates |
| Secondary | Number of occurrences of treatment-related adverse events (AE) in MM patients receiving isatuximab and lenalidomide based maintenance | 3 years | Evaluate the number of occurrences of treatment-related AES |
| Secondary | Evaluate health related quality of life in MM patients receiving isatuximab and lenalidomide based maintenance | 3 years | Complete European Organization for Research and Treatment of Cancer Quality of Life Questionnaires-C30 questionnaire at 3 years. The higher the score the worse the subject's health is and the lower the score the better the subject's health is |
| Secondary | Evaluate health related quality of life in MM patients receiving isatuximab and lenalidomide based maintenance | 3 years | Complete European Organization for Research and Treatment of Cancer Quality of Life Questionnaires-Multiple Myeloma Module at 3 years. The higher the score the worse the subject's health is and the lower the score the better the subject's health is and the lower the score the better the subject's health is |
| Secondary | Evaluate health related quality of life in MM patients receiving isatuximab and lenalidomide based maintenance | 3 years | Complete European Quality of Life Five Dimensions Questionnaire-5-level at 3 years. The higher the score the worse the subject's health is and the lower the score the better the subject's health is |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT05344833/registered