Trial · NCT06679101
A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)
NCT06679101, Phase 3, Recruiting, GlaxoSmithKline
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM). Trials, record NCT06679101. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06679101
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)
- NCT number
- NCT06679101
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 520 participants, estimated
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Multiple Myeloma, Newly Diagnosed Multiple Myeloma
- Interventions
- Belantamab mafodotin, Lenalidomide, Dexamethasone, Daratumumab
- First posted
- 2024-11-07
- Last updated
- 2026-04-22
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PFS | Up to approximately 7 years | Defined as the time from the date of randomization to the date of first documented PD per International Myeloma Working Group (IMWG) criteria by Independent Review Committee (IRC) or death from any cause in the absence of progression, whichever occurs first. |
| Primary | Number of Participants Achieving MRD Negative Status | Up to approximately 7 years | Defined as achieving MRD negativity at 10\^-5 sensitivity threshold (1 nucleated tumor cell in 100,000 normal cells) assessed by next-generation sequencing (NGS) at least once during the time of confirmed complete response (CR) or better response per IMWG criteria by IRC. |
| Secondary | Overall Survival (OS) | Up to approximately 7 years | |
| Secondary | PFS2 | Up to approximately 7 years | Defined as the time from the date of randomization to the date of documented PD following the first subsequent anti-myeloma therapy or death from any cause, whichever is earlier. |
| Secondary | Number of Participants Achieving CR or Better (CR+) | Up to approximately 7 years | |
| Secondary | Number of Participants Achieving Very Good Partial Response (VGPR) or Better | Up to approximately 7 years | |
| Secondary | Number of Participants Achieving Sustained MRD Negative Status | Up to approximately 7 years | Defined as achieving MRD negative status at 10\^-5 sensitivity threshold (1 nucleated tumor cell in 100,000 normal cells) assessed by NGS at least twice, a minimum of 1 year apart and with no MRD positive result in between, during the time of confirmed CR+ response per IMWG criteria by IRC. |
| Secondary | Duration of Response (DoR) | Up to approximately 7 years | |
| Secondary | Time to Second Next Line Therapy (TTST) | Up to approximately 7 years | |
| Secondary | Number of Participants With Adverse Events (AEs) | Up to approximately 7 years |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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/NCT06679101
GET https://conductscience.org/api/trials/v1/NCT06679101/registered