Trial · NCT03188172
MUK Nine b: OPTIMUM Treatment Protocol
NCT03188172, Phase 2, Unknown, University of Leeds
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. MUK Nine b: OPTIMUM Treatment Protocol. Trials, record NCT03188172. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03188172
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MUK Nine b: OPTIMUM Treatment Protocol
- NCT number
- NCT03188172
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 95 participants, estimated
- Lead sponsor
- University of Leeds
- Conditions
- Multiple Myeloma
- Interventions
- Cyclophosphamide, Bortezomib, Lenalidomide, Daratumumab, Dexamethasone, Melphalan, Filgrastim
- First posted
- 2017-06-15
- Last updated
- 2024-05-14
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03188172
GET https://conductscience.org/api/trials/v1/NCT03188172/registered