Trial · NCT06868667

Japan Expansion Cohort: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

NCT06868667, Phase 3, Active not recruiting, GlaxoSmithKline; results first posted 2025-05-09

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Japan Expansion Cohort: 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 NCT06868667. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06868667

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Japan Expansion Cohort: 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: NCT06868667
Status: Active not recruiting
Phases: Phase 3
Enrollment: 24 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Multiple Myeloma
Interventions: Belantamab mafodotin, Daratumumab, Bortezomib, Dexamethasone
First posted: 2025-03-11
Last updated: 2026-04-23
Results first posted: 2025-05-09

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 32 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	Overall Survival (OS)	Up to 255 weeks	OS is defined as time from the date of randomization until the date of death due to any cause.
Secondary	Duration of Response (DoR)	Up to 255 weeks	DOR is defined as time from first documented evidence of partial response or better until first documented progression or death, whichever occurs first.
Secondary	Minimal Residual Disease (MRD) Negativity Rate	Up to 255 weeks	Minimal Residual Disease (MRD) negativity rate is defined as the percentage of participants who are MRD negative by next generation sequencing (NGS).
Secondary	Complete Response Rate (CRR)	Up to 255 weeks	CRR is defined as percentage of participants with a confirmed complete response (CR) or better (i.e., CR, stringent Complete Response (sCR)).
Secondary	Overall Response Rate (ORR)	Up to 255 weeks	ORR is defined as percentage of participants with a confirmed partial response (PR) or better (i.e. PR, Very Good Partial Response \[VGPR\], CR or sCR).
Secondary	Clinical Benefit Rate (CBR)	Up to 255 weeks	CBR is defined as percentage of participants with a confirmed minimal response (MR) or better per International Myeloma Working Group (IMWG).
Secondary	Time to Response (TTR)	Up to 255 weeks	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 255 weeks	TTP is defined as the time from the date of randomization until the earliest date of documented PD or death due to PD. 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	Progression-free Survival on Subsequent Line of Therapy (PFS2)	Up to 255 weeks	PFS2 is defined as time from randomization to disease progression after initiation of new anti-myeloma therapy or death from any cause, whichever is earlier. If disease progression after new anti-myeloma 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

1 to 10 of 23Source ClinicalTrials.gov

See all 23 registered outcomes

Outcomes23

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 32 months	Intent-to-Treat (ITT) Population included all randomized participants whether or not randomized treatment was administered.	Months	MEDIAN
SECONDARY	Overall Survival (OS)	Up to 255 weeks
SECONDARY	Duration of Response (DoR)	Up to 255 weeks
SECONDARY	Minimal Residual Disease (MRD) Negativity Rate	Up to 255 weeks
SECONDARY	Complete Response Rate (CRR)	Up to 255 weeks
SECONDARY	Overall Response Rate (ORR)	Up to 255 weeks
SECONDARY	Clinical Benefit Rate (CBR)	Up to 255 weeks
SECONDARY	Time to Response (TTR)	Up to 255 weeks
SECONDARY	Time to Progression (TTP)	Up to 255 weeks
SECONDARY	Progression-free Survival on Subsequent Line of Therapy (PFS2)	Up to 255 weeks

1 to 10 of 23Source ClinicalTrials.gov

See all 23 outcomes

Results 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)		NA	95% Confidence Interval 7.0 to NA	Months
Progression-free Survival (PFS)	Daratumumab + Bor + Dex		11.1	95% Confidence Interval 4.9 to NA	Months

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex)	10
Overall Study	STARTED	Daratumumab + Bor + Dex	14
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)	10
Overall Study	NOT COMPLETED	Daratumumab + Bor + Dex	14

Source ClinicalTrials.gov

Adverse events318

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	Malaise	General disorders	Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex)	4	10	4
other	Malaise	General disorders	Daratumumab + Bor + Dex	3	14	3
other	Pyrexia	General disorders	Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex)	2	10	2
other	Pyrexia	General disorders	Daratumumab + Bor + Dex	4	14	5
other	Injection site erythema	General disorders	Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex)	3	10	3
other	Injection site erythema	General disorders	Daratumumab + Bor + Dex	2	14	2
other	Sensation of foreign body	General disorders	Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex)	3	10	7
other	Sensation of foreign body	General disorders	Daratumumab + Bor + Dex	0	14	0
other	Infusion site erythema	General disorders	Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex)	0	10	0
other	Infusion site erythema	General disorders	Daratumumab + Bor + Dex	2	14	2

1 to 10 of 318Source ClinicalTrials.gov

See all 318 adverse events

Adverse 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)	0	10
Total, all-cause mortality	Daratumumab + Bor + Dex	4	14
Total, other adverse events	Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex)	10	10
Total, other adverse events	Daratumumab + Bor + Dex	14	14
Total, serious adverse events	Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex)	7	10
Total, serious adverse events	Daratumumab + Bor + Dex	2	14

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 + 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT06868667

GET https://conductscience.org/api/trials/v1/NCT06868667/registered?page=2

API reference For AI assistants