Trial · NCT05218603
Evaluation of Maintenance With Bortezomib Plus Daratumumab (V-Dara) After Induction With Bortezomib, Melphalan, Prednisone Plus Daratumumab (VMP-Dara) in Newly Diagnosed Multiple Myeloma (MM) Patients Non-eligible for autoSCT
NCT05218603, Unknown, PETHEMA Foundation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Maintenance With Bortezomib Plus Daratumumab (V-Dara) After Induction With Bortezomib, Melphalan, Prednisone Plus Daratumumab (VMP-Dara) in Newly Diagnosed Multiple Myeloma (MM) Patients Non-eligible for autoSCT. Trials, record NCT05218603. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05218603
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Evaluation of Maintenance With Bortezomib Plus Daratumumab (V-Dara) After Induction With Bortezomib, Melphalan, Prednisone Plus Daratumumab (VMP-Dara) in Newly Diagnosed Multiple Myeloma (MM) Patients Non-eligible for autoSCT
- NCT number
- NCT05218603
- Status
- Unknown
- Enrollment
- 100 participants, estimated
- Lead sponsor
- PETHEMA Foundation
- Conditions
- Multiple Myeloma, Non-eligible for Autologous Stem Cell Transplantation (ASCT)
- Interventions
- Bortezomib, Daratumumab
- First posted
- 2022-02-01
- Last updated
- 2022-09-16
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Throughout the study period. Approximately 4 years | Time from the start of induction with VMPDara until disease progression or death, whichever comes first |
| Secondary | Description of MRD status and depth | Throughout the study period. Approximately 4 years | Description of MRD status and depth, that will be conducted on bone marrow samples and outside of the bone marrow through imaging techniques if available per routine clinical practice, according to the investigator's criteria. |
| Secondary | Stringent Complete Response (sCR) rate | Throughout the study period. Approximately 4 years | |
| Secondary | Complete Response (CR) rate | Throughout the study period. Approximately 4 years | |
| Secondary | Proportion of subjects who achieve Very Good Partial Response (VGPR) or better | Throughout the study period. Approximately 4 years | |
| Secondary | Overall Response Rate (ORR) | Throughout the study period. Approximately 4 years | |
| Secondary | Duration of response | Throughout the study period. Approximately 4 years | Duration of response calculated from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease. |
| Secondary | Time to Progression (TTP) | Throughout the study period. Approximately 4 years | Time to Progression (TTP), defined as the time from the date of start of VMP-Dara to the date of first documented evidence of PD. |
| Secondary | Incidence of adverse events (AEs) | Throughout the study period. Approximately 4 years | Number of patients experiencing AEs, classified according to severity. |
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.
Papers34
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/NCT05218603
GET https://conductscience.org/api/trials/v1/NCT05218603/papers?page=2