Trial · NCT04802356
Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma Patients
NCT04802356, Phase 2, Active not recruiting, PETHEMA Foundation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma Patients. Trials, record NCT04802356. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04802356
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma Patients
- NCT number
- NCT04802356
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- PETHEMA Foundation
- Conditions
- Multiple Myeloma
- Interventions
- Belantamab mafodotin, Bortezomib, Lenalidomide, Dexamethasone, Autologous stem cell transplant (ASCT)
- First posted
- 2021-03-17
- Last updated
- 2026-03-05
- Other registries' IDs
- eudract:2020-002050-24
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of deaths | Throughout the study period. Approximately 48 months | Number of patients that are exitus after start of the study treatment |
| Primary | Incidence of adverse events (AEs) | Throughout the study period. Approximately 48 months | Number of patients experiencing AEs, either treatment or non-treatment related, classified according to severity and graded according to NCTCAE V4.0 |
| Primary | Incidence of analytical alterations | Throughout the study period. Approximately 48 months | Changes in laboratory analytes from the hematology and blood chemistry panel after start of the study experimental treatment |
| Primary | Incidence of ocular events | Throughout the study period. Approximately 48 months | Number of patients experiencing ocular alterations after start of the study experimental treatment. |
| Secondary | Overall Response Rate (ORR) | Throughout the study period. Approximately 48 months | The percentage of participants with a confirmed partial response (PR) or better (PR, Very good partial response (VGPR), Complete response (CR), stringent complete response (sCR)). Assessed Q4W during induction, three months after ASCT, after consolidation, q4W during maintenance until PD, unacceptable toxicity, death, withdrawal of consent, loss to follow-up or end of the study. |
| Secondary | Complete Response Rate (CRR) | Throughout the study period. Approximately 48 months | The percentage of participants with a confirmed complete response (CR) or better (stringent complete response (CR, sCR)). Assessed Q4W during induction, three months after ASCT, after consolidation, q4W during maintenance until PD, unacceptable toxicity, death, withdrawal of consent, loss to follow-up or end of the study. |
| Secondary | Minimal Residual Disease (MRD) negativity rate | Throughout the study period. Approximately 48 months | The percentage of participants who are MRD negative by next-generation flow cytometry (NGF). MRD will be evaluated after each phase of treatment (induction, autologous stem cell transplant, consolidation and once a year during maintenance). If there is suspect of CR at any time different of those previously specified, the MRD should be evaluated at the suspicion of CR. Assessed Q4W during induction, three months after ASCT, after consolidation, q4W during maintenance until PD, unacceptable toxicity, death, withdrawal of consent, loss to follow-up or end of the study. |
| Secondary | Time to Response (TTR) | Throughout the study period. Approximately 48 months | The time from the date of inclusion and the first documented evidence of response (PR or better) among participants who achieve confirmed PR or better. |
| Secondary | Duration of Response (DoR) | Throughout the study period. Approximately 48 months | The 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. |
| Secondary | Progression-Free Survival (PFS) | Throughout the study period. Approximately 48 months | The time from the date of inclusion until the earliest date of documented disease progression or death due to any cause. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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.
Papers10
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/NCT04802356
GET https://conductscience.org/api/trials/v1/NCT04802356/registered