Trial · NCT05558319
NDMM Patients Candidates for ASCT Comparing Extended VRD Plus vs. Isa-VRD vs. Isa-V-Iberdomide
NCT05558319, Phase 3, Recruiting, PETHEMA Foundation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. NDMM Patients Candidates for ASCT Comparing Extended VRD Plus vs. Isa-VRD vs. Isa-V-Iberdomide. Trials, record NCT05558319. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05558319
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- NDMM Patients Candidates for ASCT Comparing Extended VRD Plus vs. Isa-VRD vs. Isa-V-Iberdomide
- NCT number
- NCT05558319
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 480 participants, estimated
- Lead sponsor
- PETHEMA Foundation
- Conditions
- Newly Diagnosed Multiple Myeloma
- Interventions
- Bortezomib, Isatuximab, Iberdomide, Lenalidomide, Dexamethasone
- First posted
- 2022-09-28
- Last updated
- 2026-06-25
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy in terms of patients who are MRD-negative by NGF | 24 months | Percentage of patients who are MRD-negative by next generation flow cytometry (NGF) after 18 cycles + ASCT comparing the efficacy of extended VRD + ASCT plus ERI \& (Arm B) vs. IsatuximabVRD + ASCT (Arm A). |
| Secondary | Frequency of adverse events (AEs) | Throughout the study. Approximately 78 months. | Number of patients who presented AEs in each arm to perform safety analysis. NOTE: Due to the experimental nature of the Arm C combination Isatuximab-Iberdomide-Bortezomib-Dex, a safety analysis will be performed with the first 5 patients included in each arm as per section, a second one when 25 patients in each arm have completed 3 cycles of therapy, and subsequent ones might be required if considered by the Primary-Investigator, Co-Primary-Investigator, Co-coordinators and Co-Investigator. |
| Secondary | Progression-Free Survival (PFS) | Throughout the study. Approximately 78 months | Time from the start of treatment until the earliest date of documented disease progression or death due to any cause. |
| Other | Overall Response Rate (ORR) | Throughout the study. Approximately 78 months | Percentage of participants with a confirmed partial response (PR) or better (PR, VGPR, CR, sCR). |
| Other | Complete Response Rate (CRR) | Throughout the study. Approximately 78 months | The percentage of participants with a confirmed complete response (CR) or better (stringent complete response (CR, sCR)). |
| Other | Time to Response (TTR) | Throughout the study. Approximately 78 months | Time from the start of treatment and the first documented evidence of response (PR or better) among participants who achieve confirmed PR or better. |
| Other | Duration of Response (DoR) | Throughout the study. Approximately 78 months | Time from first documented evidence of PR or better until progressive disease (PD) or death due to PD among participants who achieved PR or better. |
| Other | Overall Survival (OS) | Throughout the study. Approximately 78 months | Time from the start of treatment until the date of death due to any cause |
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.
Papers30
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/NCT05558319
GET https://conductscience.org/api/trials/v1/NCT05558319/papers?page=2