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Clinical trial · no report yet · Phase 1
DREAMM-1 trial: what clinicians have said so far
Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916
- NCT02064387 ↗
- Completed
- GlaxoSmithKline
- Standard size, estimated: 151–300 verified statements
We haven't built an HCP commentary report on DREAMM-1 (belantamab mafodotin in relapsed or refractory multiple myeloma) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on DREAMM-1 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Indexed so far | |
|---|---|
| 9 posts on X | |
| 5 YouTube videos |
The trial
ClinicalTrials.gov- Official title
- A Phase I Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of the Antibody Drug Conjugate GSK2857916 in Subjects With Relapsed/Refractory Multiple Myeloma and Other Advanced Hematologic Malignancies Expressing BCMA
- Phase
- Phase 1
- Status
- Completed
- Conditions
- Multiple Myeloma
- Interventions
- GSK2857916
- Arms
- Schedule 1 Part 1 · Experimental
- Schedule 2 Part 1 · Experimental
- Schedule 1 Part 2 · Experimental
- Schedule 2 Part 2 · Experimental
- Enrollment
- 79
- Primary outcomes
- Number of Participants With Serious Adverse Events (SAEs) and Common (>=5%) Non-serious Adverse Events- Part 1
- Number of Participants With SAEs and Common (>=5%) Non-serious Adverse Events- Part 2 (MM)
- Number of Participants With SAEs and Common (>=5%) Non-serious Adverse Events- Part 2 (NHL)
- Number of Participants With Dose-limiting Toxicities (DLTs) During the Determinative Period- Part 1
- Number of Participants With Grade Change From Baseline in Vital Signs-DBP & SBP-Part 1
- Number of Participants With Grade Change From Baseline in Vital Signs-DBP & SBP-Part 2 (MM)
- Number of Participants With Grade Change From Baseline in Vital Signs-DBP & SBP-Part 2 (NHL)
- Number of Participants With Change From Baseline in Heart Rate and Temperature-Part 1
- Number of Participants With Change From Baseline in Heart Rate and Temperature-Part 2 (MM)
- Number of Participants With Change From Baseline in Heart Rate and Temperature-Part 2 (NHL)
- Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1
- Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2 (MM)
- Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2 (NHL)
- Number of Participants With Change From Baseline in Clinical Chemistry Data With Respect to Normal Range-Part 1
- Number of Participants With Change From Baseline in Clinical Chemistry Data With Respect to Normal Range-Part 2 (MM)
- Number of Participants With Change From Baseline in Clinical Chemistry Data With Respect to Normal Range-Part 2 (NHL)
- Number of Participants With Grade Change From Baseline in Hematology Data-Part 1
- Number of Participants With Grade Change From Baseline in Hematology Data-Part 2 (MM)
- Number of Participants With Grade Change From Baseline in Hematology Data-Part 2 (NHL)
- Number of Participants With Change From Baseline in Hematology Data With Respect to Normal Range-Part 1
- Number of Participants With Change From Baseline in Hematology Data With Respect to Normal Range-Part 2 (MM)
- Number of Participants With Change From Baseline in Hematology Data With Respect to Normal Range-Part 2 (NHL)
- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method -Part 1
- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method -Part 2 (MM)
- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method -Part 2 (NHL)
- Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.06 mg/kg
- Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.03 mg/kg and 0.12 mg/kg
- Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.24 mg/kg
- Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.48 mg/kg
- Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.96 mg/kg
- Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 1.92 mg/kg
- Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 2.50 mg/kg
- Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 3.40 mg/kg and 4.60 mg/kg
- Change From Baseline in Urine Protein Excretion (24 Hour)-Part 2 (MM)
- Change From Baseline in Urine Protein Excretion (24 Hour)-Part 2 (NHL)
- Sponsor
- GlaxoSmithKline
- Start
- Jul 29, 2014
- Primary completion
- Aug 31, 2018
- Results posted
- Yes
- Registry record
- NCT02064387 · updated Aug 11, 2020
Publications
linked from the registry- Trudel S, Lendvai N, Popat R, Voorhees PM, Reeves B, Libby EN, Richardson PG, Hoos A, Gupta I, Bragulat V, He Z, Opalinska JB, Cohen AD. Antibody-drug conjugate, GSK2857916, in relapsed/refractory multiple myeloma: an update on safety and efficacy from dose expansion phase I study. Blood Cancer J. 2019 Mar 20;9(4):37. doi: 10.1038/s41408-019-0196-6. PubMed 30894515
- Collins J, van Noort M, Rathi C, Post TM, Struemper H, Jewell RC, Ferron-Brady G. Longitudinal efficacy and safety modeling and simulation framework to aid dose selection of belantamab mafodotin for patients with multiple myeloma. CPT Pharmacometrics Syst Pharmacol. 2023 Oct;12(10):1411-1424. doi: 10.1002/psp4.13016. Epub 2023 Aug 2. PubMed 37465991
- Trudel S, Lendvai N, Popat R, Voorhees PM, Reeves B, Libby EN, Richardson PG, Anderson LD Jr, Sutherland HJ, Yong K, Hoos A, Gorczyca MM, Lahiri S, He Z, Austin DJ, Opalinska JB, Cohen AD. Targeting B-cell maturation antigen with GSK2857916 antibody-drug conjugate in relapsed or refractory multiple myeloma (BMA117159): a dose escalation and expansion phase 1 trial. Lancet Oncol. 2018 Dec;19(12):1641-1653. doi: 10.1016/S1470-2045(18)30576-X. Epub 2018 Nov 12. PubMed 30442502
- Tai YT, Anderson KC. Targeting B-cell maturation antigen in multiple myeloma. Immunotherapy. 2015;7(11):1187-99. doi: 10.2217/imt.15.77. Epub 2015 Sep 15. PubMed 26370838