Trial · NCT06956170
All Japanese Population: Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma
NCT06956170, Phase 3, Active not recruiting, GlaxoSmithKline; results first posted 2025-06-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. All Japanese Population: Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma. Trials, record NCT06956170. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06956170
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- All Japanese Population: Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma
- NCT number
- NCT06956170
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 21 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Multiple Myeloma
- Interventions
- Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
- First posted
- 2025-05-04
- Last updated
- 2026-06-12
- Results first posted
- 2025-06-11
Source ClinicalTrials.gov
Registered outcomes29
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 120 weeks | 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 is defined as 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 | Overall Survival (OS) | Up to approximately 407 weeks | Overall Survival (OS) defined as the interval of time from randomization to the date of death due to any cause. |
| Secondary | Duration of Response (DoR) | Up to approximately 407 weeks | Duration of Response (DoR) defined as the time from first documented evidence of partial response (PR) or better until progressive disease (PD) or death due to any cause. Response will be based on IRC-assessment per IMWG criteria. |
| Secondary | Minimal Residual Disease (MRD) Negativity Rate | Up to approximately 407 weeks | MRD negativity rate defined as the percentage of participants who achieve MRD negative status (as assessed by NGS at 10\^5 threshold) at least once during the time of confirmed CR or better response based on IRC-assessment per IMWG. |
| Secondary | Overall Response Rate (ORR) | Up to approximately 407 weeks | ORR is defined as the percentage of participants with a confirmed partial response or better (i.e., PR, VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria. |
| Secondary | Complete Response Rate (CRR) | Up to approximately 407 weeks | Complete Response Rate (CRR), defined as the percentage of participants with a confirmed complete response (CR) or better (i.e., CR and stringent complete response (sCR)) based on IRC assessment per IMWG criteria. |
| Secondary | Percentage of Participants With a Confirmed Very Good Partial Response (VGPR) or Better | Up to approximately 407 weeks | VGPR is defined as the percentage of participants with a confirmed VGPR or better (i.e., VGPR, CR, and sCR) based on IRC-assessment per IMWG criteria. |
| Secondary | Time to Best Response (TTBR) | Up to approximately 407 weeks | Time to Best Response (TTBR) defined as the interval of time between the date of randomization and the earliest date of achieving best response among participants with a confirmed PR or better based on IRC-assessment per IMWG. |
| Secondary | Time to Response (TTR) | Up to approximately 407 weeks | Time to Response (TTR) defined as the time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve a response (i.e., confirmed PR or better) based on IRC-assessment per IMWG. |
| Secondary | Time to Progression (TTP) | Up to approximately 407 weeks | Time to Progression (TTP) defined as the time from randomization until the earliest date of PD based on IRC-assessment per IMWG criteria, or death due to PD. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
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 120 weeks | Intent-to-Treat (ITT) Population included all randomized participants whether or not randomized treatment was administered. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to approximately 407 weeks | |||
| SECONDARY | Duration of Response (DoR) | Up to approximately 407 weeks | |||
| SECONDARY | Minimal Residual Disease (MRD) Negativity Rate | Up to approximately 407 weeks | |||
| SECONDARY | Overall Response Rate (ORR) | Up to approximately 407 weeks | |||
| SECONDARY | Complete Response Rate (CRR) | Up to approximately 407 weeks | |||
| SECONDARY | Percentage of Participants With a Confirmed Very Good Partial Response (VGPR) or Better | Up to approximately 407 weeks | |||
| SECONDARY | Time to Best Response (TTBR) | Up to approximately 407 weeks | |||
| SECONDARY | Time to Response (TTR) | Up to approximately 407 weeks | |||
| SECONDARY | Time to Progression (TTP) | Up to approximately 407 weeks |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 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+Pomalidomide+Dexamethasone | NA | 95% Confidence Interval 0.2 to NA | Months | |
| Progression-Free Survival (PFS) | Bortezomib + Pomalidomide + Dexamethasone | 14.8 | 95% Confidence Interval 1.9 to NA | Months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Belantamab Mafodotin+Pomalidomide+Dexamethasone | 10 | |
| Overall Study | STARTED | Bortezomib + Pomalidomide + Dexamethasone | 11 | |
| Overall Study | COMPLETED | Belantamab Mafodotin+Pomalidomide+Dexamethasone | 0 | |
| Overall Study | COMPLETED | Bortezomib + Pomalidomide + Dexamethasone | 0 | |
| Overall Study | NOT COMPLETED | Belantamab Mafodotin+Pomalidomide+Dexamethasone | 10 | |
| Overall Study | NOT COMPLETED | Bortezomib + Pomalidomide + Dexamethasone | 11 |
Source ClinicalTrials.gov
Adverse events270
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 | Anaemia | Blood and lymphatic system disorders | Belantamab Mafodotin+Pomalidomide+Dexamethasone | 2 | 10 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Bortezomib + Pomalidomide + Dexamethasone | 2 | 11 | 5 |
| other | Eosinophilia | Blood and lymphatic system disorders | Belantamab Mafodotin+Pomalidomide+Dexamethasone | 0 | 10 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Bortezomib + Pomalidomide + Dexamethasone | 1 | 11 | 2 |
| other | Leukocytosis | Blood and lymphatic system disorders | Belantamab Mafodotin+Pomalidomide+Dexamethasone | 0 | 10 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Bortezomib + Pomalidomide + Dexamethasone | 1 | 11 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | Belantamab Mafodotin+Pomalidomide+Dexamethasone | 0 | 10 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Bortezomib + Pomalidomide + Dexamethasone | 2 | 11 | 2 |
| other | Lymphopenia | Blood and lymphatic system disorders | Belantamab Mafodotin+Pomalidomide+Dexamethasone | 0 | 10 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Bortezomib + Pomalidomide + Dexamethasone | 1 | 11 | 1 |
1 to 10 of 270Source ClinicalTrials.gov
See all 270 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Belantamab Mafodotin+Pomalidomide+Dexamethasone | 2 | 10 |
| Total, all-cause mortality | Bortezomib + Pomalidomide + Dexamethasone | 1 | 11 |
| Total, other adverse events | Belantamab Mafodotin+Pomalidomide+Dexamethasone | 10 | 10 |
| Total, other adverse events | Bortezomib + Pomalidomide + Dexamethasone | 11 | 11 |
| Total, serious adverse events | Belantamab Mafodotin+Pomalidomide+Dexamethasone | 5 | 10 |
| Total, serious adverse events | Bortezomib + Pomalidomide + Dexamethasone | 4 | 11 |
Source ClinicalTrials.gov
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Belantamab Mafodotin+Pomalidomide+Dexamethasone vs Bortezomib + Pomalidomide + Dexamethasone: deaths from any cause | Trial comparisons |
| Belantamab Mafodotin+Pomalidomide+Dexamethasone vs Bortezomib + Pomalidomide + Dexamethasone: 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/NCT06956170
GET https://conductscience.org/api/trials/v1/NCT06956170/registered?page=2