Trial · NCT05280275
A Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin in Combination With Daratumumab, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Transplant Ineligible
NCT05280275, 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, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Transplant Ineligible. Trials, record NCT05280275. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05280275
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, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Transplant Ineligible
- NCT number
- NCT05280275
- Status
- Unknown
- Phases
- Phase 1, Phase 2
- Enrollment
- 36 participants, estimated
- Lead sponsor
- Hellenic Society of Hematology
- Conditions
- Multiple Myeloma, Neoplasms, Neoplasms, Plasma Cell, Gammopathy, Monoclonal, Paraproteinemias, Blood Protein Disorders, Haematologic Disease, Corneal Disease
- Interventions
- Belantamab Mafodotin-Blmf, Daratumumab, Lenalidomide, Dexamethasone
- First posted
- 2022-03-15
- Last updated
- 2023-12-01
Source ClinicalTrials.gov
Registered outcomes19
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 (%) of participants and 95% CI with the DLT in each of the cohorts 1-2, using the DLT evaluable population. |
| Primary | Part 1 and 2: Adverse Events (AEs) and Serious adverse events (SAEs) | Up to 4 years | The number (%) of participants with AEs and SAEs in each of the cohorts 1-2, using the DLT evaluable and Safety populations. |
| Primary | Part 1 and 2: Ocular toxicity | Up to 4 years | Number of participants with ocular toxicity of Grade 2 or higher (per 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: Overall Response Rate | Up to 4 years | ORR and 95% CI as per IMWG by Investigator Assessment. ORR is defined as the percentage of participants with a confirmed PR, VGPR, CR or sCR. |
| Secondary | Part 1 and 2: Lenalidomide Relative Dose Intensity (RDI) | Up to 4 years | The RDI is defined as the percentage of the total administered over the total planned lenalidomide dose. |
| 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, lenalidomide and dexamethasone, i.e., the total dose of belantamab mafodotin that was administered. |
| Secondary | Part 1: Very good partial response | Up to 4 years | VGPR+ and 95% CI as per IMWG by Investigator Assessment (ITT population) \[Part 1 only\]; 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). Descriptive methods will be used for the estimation of the time to response (i.e., mean, standard deviation, median, 1st and 3rd quartiles, minimum value and maximum value). |
| 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. The Kaplan-Meier method will be used for the estimation of DoR. The median DoR will be presented along with the respective 95% confidence intervals \[CIs\]) and the 1st and 3rd quartiles. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 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/NCT05280275
GET https://conductscience.org/api/trials/v1/NCT05280275/registered