Trial · NCT03188172
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression free survival | At 18 months post registration | Defined as the time from registration until first documented evidence of progressive disease or death. Participants not progressed at analysis will be censored at the last date known to be alive and progression free. |
| Secondary | Occurrence of Serious Adverse Events(SAE) and Suspected, Unexpected Serious Adverse Reactions (SUSAR) | At 120 days post autologous stem cell transplant (ASCT) | Will be reported based on occurrence of SAE \& SUSARs with details of causality and expectedness. |
| Secondary | Progression free survival at 100 days post autologous stem cell transplant | At 100 days post ASCT | Determine whether the treatment schedule should be dropped for futility |
| Secondary | Minimal residual disease (MRD) negative disease | At 100 days post ASCT | Defined as absence of aberrant phenotype plasma cells |
| Secondary | Overall survival | At 12 months, 24 months & 36 months post registration | Median overall survival estimates |
| Secondary | Maximum response | From registration to end of induction therapy, 100 days post ASCT, post consolidation part 2 | Proportion of participants achieving each response category. Time from registration until the participant achieves a maximum response. |
| Secondary | Overall response | At end of induction therapy, 100 days post ASCT, post consolidation part 2 | Proportion of participants receiving at least a partial response |
| Secondary | Second progression free survival | From registration until second disease progression, 3 years | Time from registration to second disease progression or death. |
| Secondary | Overall treatment benefit | At the end of induction therapy and 100 days post autologous stem cell transplant | Clinician assessment of treatment benefit will be obtained |
| Secondary | Quality of life using the EQ-5D questionnaire | From registration until second disease progression, 3 years | Quality of life will be summarised at each post-registration timepoint, adjusting for baseline mean scores and 95% confidence intervals. This will also be summarised descriptively using bar charts, box plots, plots of mean QoL over time and summary tables. |
| Secondary | Quality of life using the EORTC QLQ-C30 questionnaire | From registration until second disease progression, 3 years | Quality of life will be summarised at each post-registration timepoint, adjusting for baseline mean scores and 95% confidence intervals. This will also be summarised descriptively using bar charts, box plots, plots of mean QoL over time and summary tables. |
| Secondary | Quality of life using the QLQ-MY20 questionnaire | From registration until second disease progression, 3 years | Quality of life will be summarised at each post-registration timepoint, adjusting for baseline mean scores and 95% confidence intervals. This will also be summarised descriptively using bar charts, box plots, plots of mean QoL over time and summary tables. |
| Other | Progression free survival (comparison with Myeloma XI/XI+ data) | From registration until second disease progression, 3 years | Matched comparison of progression free survival |
| Other | Impact of minimal residual disease on progression free survival | From registration until second disease progression, 3 years | Analysis will include any participant with a MRD assessment |
| Other | Genomic instability | From registration until second disease progression, 3 years | To be investigated in an exploratory manner and will include analysis of new genetic abnormalities |
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/NCT03188172/registered