Trial · NCT07889323
REAL World IMROZ OutcomEs (REALIZE Study)
NCT07889323, Not yet recruiting, The Royal Wolverhampton Hospitals NHS Trust
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. REAL World IMROZ OutcomEs (REALIZE Study). Trials, record NCT07889323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07889323
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- REAL World IMROZ OutcomEs (REALIZE Study)
- NCT number
- NCT07889323
- Status
- Not yet recruiting
- Enrollment
- 150 participants, estimated
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Conditions
- Newly Diagnosed Multiple Myeloma (NDMM)
- First posted
- 2026-10-22
- Last updated
- 2026-11-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Responses | within 12 months | Responses will be evaluated using the IMWG 2016 uniform response criteria and the ORR will be calculated by evaluating the number and proportion of patients who achieve ≥partial response |
| Primary | Treatment discontinuation rate | within 12 months of receiving their first dose of Isa-VRD | Treatment discontinuation rate at 12 months will be analysed by collecting data on the number and proportion of patients who discontinued treatment within 12 months of receiving their first dose of Isa-VRD |
| Primary | Relative Dose Intensity | within 12 months of receiving their first dose of Isa-VRD | RDI within the first 12 months of treatment for each agent within Isa-VRD will be calculated by collecting the number and dose of each treatment delivered within the 12 month timeframe following their firs dose of Isa-VRD. Data on renal function will also be collected to ensure the lenalidomide dose intensity is calculated taking into account the adjusted dosing schedule for lenalidomide according to the summary of product characteristics for lenalidomide (7) |
| Primary | Progression-Free Survival | 12-months from their first dose of Isa-VRD | 12-month PFS will be calculated as the proportion of patients alive and progression free at 12-months from their first dose of Isa-VRD |
| Primary | Overall Survival | 12 months from their first dose of Isa-VRD | 12-month OS defined as the proportion patients alive at 12 months from their first dose of Isa-VRD |
| Primary | Rate of PRD negativity | 12-months from the start of Isa-VRD | Rate of PRD negativity, as defined by EXENT GAM assay negativity, will be assessed at 12-months from the start of Isa-VRD |
| Primary | Proportion of patients maintaining sustained PRD-negative status | 24-months from the start of Isa-VRD | Proportion of patients maintaining sustained PRD-negative status for a minimum duration of 12 months, will be assessed by evaluating how many patients who are PRD-negative at 12-months from initiation of Isa-VRD remain PRD-negative at 24-months from the start of Isa-VRD |
| Secondary | Number and Percentage of PRD Substudy Participants with a Negative EXENT GAM Assay at 12 Months | 12 months after the start of Isa-VRD. | Peripheral residual disease (PRD) negativity is defined as a negative result using the EXENT GAM mass-spectrometry assay. The number and percentage of eligible PRD substudy participants with a negative EXENT GAM result at 12 months after starting Isa-VRD will be reported. |
| Secondary | Number and Percentage of PRD Substudy Participants Maintaining EXENT GAM Assay Negativity for 12 Months | From 12 months to 24 months after the start of Isa-VRD | Sustained PRD negativity is defined as EXENT GAM assay negativity at 12 months after starting Isa-VRD followed by maintained PRD negativity through 24 months. The number and percentage of participants meeting this definition will be reported. |
Source ClinicalTrials.gov
Outcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT07889323
GET https://conductscience.org/api/trials/v1/NCT07889323/registered