Trial · NCT04483739
Isa-KRd vs KRd in Newly Diagnosed Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplantation (IsKia TRIAL)
NCT04483739, Phase 3, Active not recruiting, European Myeloma Network B.V.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Isa-KRd vs KRd in Newly Diagnosed Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplantation (IsKia TRIAL). Trials, record NCT04483739. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04483739
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Isa-KRd vs KRd in Newly Diagnosed Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplantation (IsKia TRIAL)
- NCT number
- NCT04483739
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 302 participants, actual
- Lead sponsor
- European Myeloma Network B.V.
- Conditions
- Multiple Myeloma
- Interventions
- Carfilzomib Lenalidomide Dexamethasone, Isatuximab Carfilzomib Lenalidomide Dexamethasone
- First posted
- 2020-07-23
- Last updated
- 2026-07-16
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of MRD negativity after ASCT consolidation treatment by NGS | The end of consolidation, average of 12 months | The rate of MRD negativity is determined as the proportion of patients with MRD negativity (≥10-5 sensitivity level) after ASCT consolidation treatment using ITT principle. For patients who withdraw from the study or are lost to follow up before four post ASCT consolidation cycles, the best MRD assessment will be considered. Patients will be classified as MRD positive if they have only MRD positive test results or do not undergo MRD assessment. |
| Secondary | Post induction MRD negativity rate by NGS | The end of induction, average of 4 months | The rate of MRD negativity after induction is determined as the proportion of patients with MRD negativity (≥10-5 sensitivity level, NGS) after the induction phase using ITT principle. Patients will be classified as MRD positive if they have only MRD positive test results or do not undergo MRD assessment/sample not adequate. |
| Secondary | Progression-free survival (PFS) in the 2 arms | approximately up to 5 years | PFS will be measured from the date of randomization to the date of first observation of PD, or death from any cause as an event. Subjects who have not progressed or who withdraw from the study will be censored at the time of the last complete disease assessment. All subjects who were lost to FU will also be censored at the time of last complete disease assessment |
| Secondary | Post light-consolidation MRD negativity rate by NGS | At the end of light-consolidation, average of 24 months | The rate of MRD negativity after light consolidation is determined as the proportion of patients with MRD negativity (≥10-5 sensitivity level, NGS) after light consolidation phase using ITT principle. Patients will be classified as MRD positive if they have only MRD positive test results or do not undergo MRD assessment/sample not adequate. Patients who withdraw from the study or are lost to follow up before MRD evaluation, the best MRD assessment will be considered |
| Secondary | Overall Response Rate (ORR) post-induction | Approx 4 months | Response rate (sCR, CR, VGPR, PR, ORR) will be evaluated according to IMWG Response criteria after induction. |
| Secondary | Overall Response Rate (ORR) post-transplant | Approximately 8 months | Response rate (sCR, CR, VGPR, PR, ORR) will be evaluated according to IMWG Response criteria after ASCT. |
| Secondary | Overall Response Rate (ORR) post-consolidation | Approximately 12 months | Response rate (sCR, CR, VGPR, PR, ORR) will be evaluated according to IMWG Response criteria after consolidation. |
| Secondary | Overall Response Rate (ORR) post light-consolidation | Approximately 24 months | Response rate (sCR, CR, VGPR, PR, ORR) will be evaluated according to IMWG Response criteria after light consolidation. |
| Secondary | Post ASCT MRD negativity rate by NGS | After ASCT, approximately 8 months. | The rate of MRD negativity after ASCT is determined as the proportion of patients with MRD negativity (≥10-5 sensitivity level), NGS using ITT principle. For patients who withdraw from the study or are lost to follow up before ASCT, the best MRD assessment will be considered. Patients will be classified as MRD positive if they have only MRD positive test results or do not undergo MRD assessment. |
| Secondary | MRD negativity rate by NGF post induction | Approximately 4 months | The rate of MRD negativity (by NGF) after induction is determined as the proportion of patients with MRD negativity (≥10-5 sensitivity level) after the specific phase using ITT principle. Patients will be classified as MRD positive if they have only MRD positive test results or do not undergo MRD assessment. Patients who withdraw from the study or are lost to follow up before MRD evaluation phase, the best MRD assessment will be considered. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41942646 | DERIVED |
Source PubMed
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/NCT04483739
GET https://conductscience.org/api/trials/v1/NCT04483739/registered