# DREAMM-1 (NCT02064387)

> Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916

No report yet. It can be ordered.

- Drugs tested: belantamab mafodotin
- Indication: relapsed or refractory multiple myeloma

## Registry

- Registry record: https://clinicaltrials.gov/study/NCT02064387
- Phase: PHASE1
- Status: COMPLETED
- Sponsor: GlaxoSmithKline
- Conditions: Multiple Myeloma
- Interventions: GSK2857916
- Enrollment: 79
- Primary outcome: Number of Participants With Serious Adverse Events (SAEs) and Common (>=5%) Non-serious Adverse Events- Part 1
- Primary outcome: Number of Participants With SAEs and Common (>=5%) Non-serious Adverse Events- Part 2 (MM)
- Primary outcome: Number of Participants With SAEs and Common (>=5%) Non-serious Adverse Events- Part 2 (NHL)
- Primary outcome: Number of Participants With Dose-limiting Toxicities (DLTs) During the Determinative Period- Part 1
- Primary outcome: Number of Participants With Grade Change From Baseline in Vital Signs-DBP & SBP-Part 1
- Primary outcome: Number of Participants With Grade Change From Baseline in Vital Signs-DBP & SBP-Part 2 (MM)
- Primary outcome: Number of Participants With Grade Change From Baseline in Vital Signs-DBP & SBP-Part 2 (NHL)
- Primary outcome: Number of Participants With Change From Baseline in Heart Rate and Temperature-Part 1
- Primary outcome: Number of Participants With Change From Baseline in Heart Rate and Temperature-Part 2 (MM)
- Primary outcome: Number of Participants With Change From Baseline in Heart Rate and Temperature-Part 2 (NHL)
- Primary outcome: Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1
- Primary outcome: Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2 (MM)
- Primary outcome: Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2 (NHL)
- Primary outcome: Number of Participants With Change From Baseline in Clinical Chemistry Data With Respect to Normal Range-Part 1
- Primary outcome: Number of Participants With Change From Baseline in Clinical Chemistry Data With Respect to Normal Range-Part 2 (MM)
- Primary outcome: Number of Participants With Change From Baseline in Clinical Chemistry Data With Respect to Normal Range-Part 2 (NHL)
- Primary outcome: Number of Participants With Grade Change From Baseline in Hematology Data-Part 1
- Primary outcome: Number of Participants With Grade Change From Baseline in Hematology Data-Part 2 (MM)
- Primary outcome: Number of Participants With Grade Change From Baseline in Hematology Data-Part 2 (NHL)
- Primary outcome: Number of Participants With Change From Baseline in Hematology Data With Respect to Normal Range-Part 1
- Primary outcome: Number of Participants With Change From Baseline in Hematology Data With Respect to Normal Range-Part 2 (MM)
- Primary outcome: Number of Participants With Change From Baseline in Hematology Data With Respect to Normal Range-Part 2 (NHL)
- Primary outcome: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method -Part 1
- Primary outcome: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method -Part 2 (MM)
- Primary outcome: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method -Part 2 (NHL)
- Primary outcome: Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.06 mg/kg
- Primary outcome: Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.03 mg/kg and 0.12 mg/kg
- Primary outcome: Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.24 mg/kg
- Primary outcome: Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.48 mg/kg
- Primary outcome: Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.96 mg/kg
- Primary outcome: Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 1.92 mg/kg
- Primary outcome: Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 2.50 mg/kg
- Primary outcome: Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 3.40 mg/kg and 4.60 mg/kg
- Primary outcome: Change From Baseline in Urine Protein Excretion (24 Hour)-Part 2 (MM)
- Primary outcome: Change From Baseline in Urine Protein Excretion (24 Hour)-Part 2 (NHL)

## Indexed commentary on DREAMM-1 so far

Podcasts, YouTube videos and X posts we have indexed that name the trial. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.

- 9 posts on X
- 5 YouTube videos

## Order

Standard, $1,250 at most (a smaller delivered size costs its own price): https://www.erudio.com/contact?report=dreamm-1-nct02064387

## Free preview

POST https://www.erudio.com/api/trial-requests with {"nct_id": "NCT02064387", "email": "<work email>"}; the inbox owner confirms by the emailed link.