Trial · NCT05581875
A Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin in Combination With Daratumumab, Pomalidomide and Dexamethasone in Patients With Relapsed/ Refractory Multiple Myeloma Previously Treated With One Line Therapy Who Are Lenalidomide Refractory
NCT05581875, Phase 1, Phase 2, Unknown, Hellenic Society of Hematology
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin in Combination With Daratumumab, Pomalidomide and Dexamethasone in Patients With Relapsed/ Refractory Multiple Myeloma Previously Treated With One Line Therapy Who Are Lenalidomide Refractory. Trials, record NCT05581875. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05581875
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin in Combination With Daratumumab, Pomalidomide and Dexamethasone in Patients With Relapsed/ Refractory Multiple Myeloma Previously Treated With One Line Therapy Who Are Lenalidomide Refractory
- NCT number
- NCT05581875
- Status
- Unknown
- Phases
- Phase 1, Phase 2
- Enrollment
- 48 participants, estimated
- Lead sponsor
- Hellenic Society of Hematology
- Conditions
- Multiple Myeloma, Multiple Myeloma in Relapse, Neoplasms, Gammopathy, Monoclonal, Paraproteinemias, Blood Protein Disorders, Haematologic Disease, Corneal Disease, Neoplasms, Plasma Cell
- Interventions
- Belantamab Mafodotin-Blmf, Daratumumab, Pomalidomide, Dexamethasone
- First posted
- 2022-10-17
- Last updated
- 2022-10-17
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Dose-Limiting Toxicity (DLT) | Up to 28 days | The number (percent) of participants with DLTs using the DLT evaluable population. |
| Primary | Part 1 and 2: Adverse Events (AEs) and Serious adverse events (SAEs) | Up to 4 years | The number (percent) of participants with AEs and SAEs using the DLT evaluable and Safety populations. |
| Primary | Part 1 and 2: Ocular Toxicity | Up to 4 years | The number (percent) of participants with Grade ≥2 ocular toxicity per Keratopathy Visual Acuity (KVA) scale. |
| Primary | Part 2: Overall Response Rate (ORR) | Up to 4 years | ORR as per IMWG by Investigator assessment; defined as the percentage of participants with a confirmed partial response (PR), very good partial response (VGPR), complete response (CR) or stringent CR (sCR) (For the 'intention to treat' (ITT) population). |
| Secondary | Part 1 and 2: Cumulative dose of belantamab mafodotin | Up to 4 years | Cumulative belantamab mafodotin dose of (DLT evaluable population, safety population) administered in combination with daratumumab, pomalidomide and dexamethasone, i.e., the total dose of belantamab mafodotin that was administered. |
| Secondary | Part 1: Overall Response Rate (ORR) | Up to 4 years | ORR and 95% CI as per IMWG by Investigator Assessment (ITT population); ORR is defined as the percentage of participants with a confirmed PR, VGPR, CR or sCR. |
| Secondary | Part 1: Very good partial response (VGPR) | Up to 4 years | VGPR+ and 95% CI as per IMWG by Investigator Assessment (ITT population);ORR is defined as the percentage of participants with a confirmed VGPR, CR or sCR. |
| Secondary | Part 1 and 2: Time to response (TTR) | Up to 4 years | TTR as per IMWG by Investigator Assessment (ITT population). TTR is defined as the time (in months) between the date of randomization and the first evidence of confirmed response (PR or better) for participants who achieve a response (i.e., confirmed PR or better). |
| Secondary | Part 1 and 2: Duration of Response | Up to 4 years | DoR as per IMWG by Investigator Assessment (ITT population). DoR is defined as the time (months) from first evidence of confirmed PR or better until the earliest date of: documented disease progression (PD) per IMWG response criteria; or death due to PD among participants who achieved a response of PR or better. For alive and progression-free participants, data will be censored at the date of initiation of the subsequent line of treatment or at the last date of follow-up that the participant was known to be alive and progression-free. |
| Secondary | Part 1 and 2: Complete Response Rate (CRR) | Up to 4 years | CRR as per IMWG by Investigator Assessment (ITT population). CRR is defined as the percentage of participants with a confirmed CR or sCR. The denominator will be the total number of participants in each population and group respectively. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05581875
GET https://conductscience.org/api/trials/v1/NCT05581875/registered?page=2