Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05714839 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments

Study acronym: DynaMMic-1
StatusRecruiting
PhasePhase 1/2
Started2023-06-14
View on ClinicalTrials.gov ↗
The study consists of three parts: * Part 1: The primary purpose of this part aims to evaluate the safety, tolerability, and clinical activity of escalating doses of single agent belantamab in participants with refractory multiple myeloma (RRMM) who have received at least 3 prior therapies (4L+). * Part 2: The primary purpose of this part is to evaluate the safety, tolerability, and clinical activity of different doses of belantamab in combination with a fixed dose of Belantamab mafodotin (delivered as separate drugs) in participants with RRMM who have received at least 3 prior therapies (4L+). * Part 3: The Primary purpose of this part will evaluate the clinical activity of a selected dose of the belantamab in combination with the pomalidomide-dexamethasone (Pd) standard of care (SoC) backbone. The study will focus on participants with multiple myeloma who have undergone at least one prior line of therapy, including treatment with lenalidomide.

Amendment history 8 changes detected by DataLookout

2026-08-20
Primary endpoint(s) modified
WasPart 1 and 2: Number of Participants with Dose Limiting Toxicities (DLTs), Part 1, 2 and 3: Number of Participants with Worst Case Grade Change from Baseline in Laboratory and Vital Sign Parameters, Part 1, 2 and 3: Number of Participants with any Adverse Event, Part 1, 2 and 3: Number of Participants with severity of ocular events by the Keratopathy Visual Acuity (KVA) scale, Part 2: Overall Response Rate (ORR), Part 3: Very Good Partial Response and better rate (VGPR+)
NowPart 1 (Dose escalation cohort) and Part 2: Number of Participants with Dose Limiting Toxicities (DLTs), Part 1, 2 and 3: Number of Participants with Worst Case Grade Change from Baseline in Laboratory and Vital Sign Parameters, Part 2: Number of Participants with severity of ocular events by the Keratopathy Visual Acuity (KVA) scale, Part 2: Overall Response Rate (ORR), Part 3: Very Good Partial Response and better rate (VGPR+), Parts 1, 2 and 3: Number of Participants with any Adverse Event
2026-08-20
Trial sites expanded: 36 → 44 locations
2026-07-11
Primary endpoint(s) modified
WasPart 1, 2 and 3: Number of Participants with any Adverse Event, Part 1, 2 and 3: Number of Participants with severity of ocular events by the Keratopathy Visual Acuity (KVA) scale, Part 1, 2and 3: Number of Participants with Worst Case Grade Change from Baseline in Laboratory and Vital Sign Parameters, Part 1: Number of Participants with Dose Limiting Toxicities (DLTs), Part 2: Overall Response Rate (ORR), Part 3: Very Good Partial Response and better rate (VGPR+)
NowPart 1 and 2: Number of Participants with Dose Limiting Toxicities (DLTs), Part 1, 2 and 3: Number of Participants with Worst Case Grade Change from Baseline in Laboratory and Vital Sign Parameters, Part 1, 2 and 3: Number of Participants with any Adverse Event, Part 1, 2 and 3: Number of Participants with severity of ocular events by the Keratopathy Visual Acuity (KVA) scale, Part 2: Overall Response Rate (ORR), Part 3: Very Good Partial Response and better rate (VGPR+)
2026-07-11
Enrollment reduced: 152 → 123 participants
2026-07-11
Trial sites expanded: 30 → 36 locations
2026-07-11
Primary completion moved earlier: 2029-12-03 → 2028-08-03
2026-07-11
Completion moved earlier: 2029-12-03 → 2028-08-03
2026-05-23
Trial sites expanded: 27 → 30 locations
Trial Details
NCT Number NCT05714839
Lead Sponsor GlaxoSmithKline
Conditions Multiple Myeloma
Enrollment 123 participants
Start Date 2023-06-14
Primary Completion 2028-08-03 (estimated)
Study Completion 2028-08-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-19