Trial · NCT05060627
Study of Belantamab Mafodotin in Combination With Kd for the Treatment of Relapsed Myeloma Patients, Refractory to Lenalidomide
NCT05060627, Phase 1, Phase 2, Active not recruiting, PETHEMA Foundation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Belantamab Mafodotin in Combination With Kd for the Treatment of Relapsed Myeloma Patients, Refractory to Lenalidomide. Trials, record NCT05060627. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05060627
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Belantamab Mafodotin in Combination With Kd for the Treatment of Relapsed Myeloma Patients, Refractory to Lenalidomide
- NCT number
- NCT05060627
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- PETHEMA Foundation
- Conditions
- Relapsed Multiple Myeloma
- Interventions
- Belantamab mafodotin, Carfilzomib, Dexamethasone
- First posted
- 2021-09-29
- Last updated
- 2026-05-11
- Other registries' IDs
- eudract:2021-002125-15
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with adverse events (AEs) during the triplet-therapy in phase I. | At the end of the first 4-week cycle following a 3+3 design. | To determine the maximum tolerated dose, and the recommended phase 2 dose of belantamab mafodotin in combination with carfilzomib and dexamethasone, number of participants with adverse events (AEs) during the triplet-therapy in phase 1 will be evaluated. |
| Primary | Overall Response Rate (ORR) | 12 months. | Percentage of participants with a confirmed partial response (PR) or better (PR, VGPR, CR, sCR). |
| Primary | Minimal Residual Disease (MRD) negativity rate | At the time of CR/VGPR, and in all patients at month 12, 18, and 24, and yearly thereafter. | The percentage of participants who are MRD negative by next-generation flow cytometry (NGF). |
| Primary | Complete Response Rate (CRR) | 12 months. | The percentage of participants with a confirmed complete response (CR) or better (stringent complete response (CR, sCR)). |
| Primary | Incidence of deaths and primary cause of death. | Throughout the study. Approximately 60 months. | Frequency and percentage of deaths and primary cause of death. |
| Primary | Incidence of adverse events (AEs). | Throughout the study. Approximately 60 months. | Frequency and percentage of AEs |
| Primary | % of patients with changes in hematologic laboratory parameters | Throughout the study. Approximately 60 months. | Percentage of patients who present differences in hematologic laboratory parameters from baseline values . |
| Primary | % of patients with changes in blood chemistry laboratory parameters | Throughout the study. Approximately 60 months. | Percentage of patients who present differences in blood chemistry panel from baseline values. |
| Primary | Frequency of ocular findings on ophthalmic exam | Throughout the study. Approximately 60 months. | Ocular findings on ophthalmic exam |
| Secondary | Duration of Response (DoR) | Throughout the study. Approximately 60 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. |
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.
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/NCT05060627
GET https://conductscience.org/api/trials/v1/NCT05060627/registered