Trial · NCT04246047
Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
NCT04246047, Phase 3, Active not recruiting, GlaxoSmithKline; results first posted 2024-10-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma. Trials, record NCT04246047. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04246047
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
- NCT number
- NCT04246047
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 494 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Multiple Myeloma
- Interventions
- Belantamab mafodotin, Daratumumab, Bortezomib, Dexamethasone
- First posted
- 2020-01-29
- Last updated
- 2026-04-23
- Results first posted
- 2024-10-24
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Up to approximately 41 months | PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5 grams per deciliter {g/dL}\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200 milligrams per 24 hours {mg/24h}\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels \[absolute increase \>10mg/dL\]; appearance of new lesion,\>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1 centimeter (cm) in short axis. |
| Secondary | Complete Response Rate (CRR) | Up to 73 months | CRR is defined as percentage of participants with a confirmed complete response or better. |
| Secondary | Overall Response Rate (ORR) | Up to 73 months | ORR is defined as percentage of participants with a confirmed partial response or better. |
| Secondary | Clinical Benefit Rate (CBR) | Up to 73 months | CBR is defined as percentage of participants with a confirmed minimal response (MR) or better |
| Secondary | Duration of Response (DoR) | Up to 73 months | DOR is defined as time from first documented evidence of partial response or better until first documented progression or death, whichever occurs first. |
| Secondary | Time to Response (TTR) | Up to 73 months | TTR is defined as time from the date of randomization and the first documented evidence of response (PR or better) among participants who achieve partial response or better. |
| Secondary | Time to Progression (TTP) | Up to 73 months | TTP is defined as time from the date of randomization until the earliest date of documented date of disease progression or death, whichever occurs first. |
| Secondary | Overall Survival (OS) | Up to 73 months | OS is defined as time from the date of randomization until the date of death due to any cause. |
| Secondary | Progression-free Survival on Subsequent Line of Therapy (PFS2) | Up to 73 months | Progression-free survival on subsequent line of therapy is defined as time from randomization to disease progression after initiation of new anti-myeloma therapy or death from any cause, whichever occurs first. If disease progression after new antimyeloma therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any cause, whichever is earlier. |
| Secondary | Minimal Residual Disease (MRD) Negativity Rate | Up to 73 months | Minimal Residual Disease (MRD) negativity rate is defined as the percentage of participants who are MRD negative status by next generation sequencing (NGS). |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | Up to approximately 41 months | Intent-to-Treat (ITT) Population included of all randomized participants whether or not randomized treatment was administered. | Months | MEDIAN |
| SECONDARY | Complete Response Rate (CRR) | Up to 73 months | |||
| SECONDARY | Overall Response Rate (ORR) | Up to 73 months | |||
| SECONDARY | Clinical Benefit Rate (CBR) | Up to 73 months | |||
| SECONDARY | Duration of Response (DoR) | Up to 73 months | |||
| SECONDARY | Time to Response (TTR) | Up to 73 months | |||
| SECONDARY | Time to Progression (TTP) | Up to 73 months | |||
| SECONDARY | Overall Survival (OS) | Up to 73 months | |||
| SECONDARY | Progression-free Survival on Subsequent Line of Therapy (PFS2) | Up to 73 months | |||
| SECONDARY | Minimal Residual Disease (MRD) Negativity Rate | Up to 73 months |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) | 36.6 | 95% Confidence Interval 28.4 to NA | Months | |
| Progression-free Survival (PFS) | Daratumumab + Bor + Dex | 13.4 | 95% Confidence Interval 11.1 to 17.5 | Months |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) | 243 | |
| Overall Study | STARTED | Daratumumab + Bor + Dex | 251 | |
| Overall Study | Safety Population | Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) | 242 | |
| Overall Study | Safety Population | Daratumumab + Bor + Dex | 246 | |
| Overall Study | COMPLETED | Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) | 0 | |
| Overall Study | COMPLETED | Daratumumab + Bor + Dex | 0 | |
| Overall Study | NOT COMPLETED | Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) | 243 | |
| Overall Study | NOT COMPLETED | Daratumumab + Bor + Dex | 251 |
Source ClinicalTrials.gov
Adverse events446
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Thrombocytopenia | Blood and lymphatic system disorders | Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) | 167 | 242 | 501 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Daratumumab + Bor + Dex | 122 | 246 | 269 |
| other | Anaemia | Blood and lymphatic system disorders | Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) | 45 | 242 | 66 |
| other | Anaemia | Blood and lymphatic system disorders | Daratumumab + Bor + Dex | 64 | 246 | 110 |
| other | Neutropenia | Blood and lymphatic system disorders | Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) | 34 | 242 | 83 |
| other | Neutropenia | Blood and lymphatic system disorders | Daratumumab + Bor + Dex | 27 | 246 | 51 |
| other | Lymphopenia | Blood and lymphatic system disorders | Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) | 21 | 242 | 44 |
| other | Lymphopenia | Blood and lymphatic system disorders | Daratumumab + Bor + Dex | 23 | 246 | 38 |
| other | Leukopenia | Blood and lymphatic system disorders | Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) | 14 | 242 | 42 |
| other | Leukopenia | Blood and lymphatic system disorders | Daratumumab + Bor + Dex | 10 | 246 | 17 |
1 to 10 of 446Source ClinicalTrials.gov
See all 446 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) | 50 | 242 |
| Total, all-cause mortality | Daratumumab + Bor + Dex | 77 | 246 |
| Total, other adverse events | Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) | 238 | 242 |
| Total, other adverse events | Daratumumab + Bor + Dex | 239 | 246 |
| Total, serious adverse events | Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) | 121 | 242 |
| Total, serious adverse events | Daratumumab + Bor + Dex | 90 | 246 |
Source ClinicalTrials.gov
Papers5
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) vs Daratumumab + Bor + Dex: deaths from any cause | Trial comparisons |
| Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) vs Daratumumab + Bor + Dex: serious adverse events | Trial comparisons |
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/NCT04246047
GET https://conductscience.org/api/trials/v1/NCT04246047/registered?page=2