NCT03525678 is a Phase 2 clinical trial of Belantamab mafodotin frozen liquid in Multiple Myeloma, sponsored by GlaxoSmithKline.

Who is sponsoring NCT03525678?

NCT03525678 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT03525678?

Interventions in NCT03525678: Belantamab mafodotin frozen liquid, Belantamab mafodotin lyophilized powder.

What condition does NCT03525678 study?

NCT03525678 studies Multiple Myeloma.

Is NCT03525678 still recruiting?

NCT03525678 is currently completed. Last updated 3 September 2025.

Are results published for NCT03525678?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-09-03 · How we verify

NCT03525678

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody

Completed Phase 2 Results posted Last updated 3 September 2025

What this trial tests

Phase 2 trial testing Belantamab mafodotin frozen liquid in Multiple Myeloma in 221 participants. Completed in 12 September 2024.

Timeline

18 June 2018

Primary endpoint
21 June 2019

12 September 2024

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	221
Start date	18 June 2018
Primary completion	21 June 2019
Estimated completion	12 September 2024
Sites	59 locations across Spain, United Kingdom, Australia, United States, Canada, Italy, France, Germany

Drugs / interventions tested

Belantamab mafodotin frozen liquid — full drug profile →
Belantamab mafodotin lyophilized powder — full drug profile →

Conditions studied

Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Multiple myeloma (MM) is an incurable malignancy and accounts for 1 percentage (%) of all cancers and for 10% of all hematologic malignancies. Participants with relapsed/refractory multiple myeloma (RRMM) will be included in this study, to evaluate the efficacy and safety of belantamab mafodotin (GSK2857916) monotherapy. Participants will be treated with belantamab mafodotin monotherapy until disease progression (PD) or unacceptable toxicity and will be followed for Progression Free Survival and Overall survival. The participants will be randomized to receive either frozen belantamab mafodotin at the dose of 2.5 milligram per kilogram (mg/kg) or 3.4 mg/kg administered Intravenously (IV). There will be an independent cohort of participants who will receive a lyophilized configuration of belantamab mafodotin. For participants who discontinued from the study other than Progressive disease (PD), disease evaluation will continue to be performed at 3-week intervals until confirmed PD, death, start of a new anticancer treatment, withdrawal of consent, or end of the study whichever occurs first.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study.
Lonial S, Lee HC, Badros A, Trudel S, et al · · 2020 · cited 566× · PMID 31859245 · DOI 10.1016/s1470-2045(19)30788-0
Antibodies to watch in 2020.
Kaplon H, Muralidharan M, Schneider Z, Reichert JM. · · 2020 · cited 332× · PMID 31847708 · DOI 10.1080/19420862.2019.1703531
Antibodies to watch in 2021.
Kaplon H, Reichert JM. · · 2021 · cited 215× · PMID 33459118 · DOI 10.1080/19420862.2020.1860476
BCMA-targeted immunotherapy for multiple myeloma.
Yu B, Jiang T, Liu D. · · 2020 · cited 165× · PMID 32943087 · DOI 10.1186/s13045-020-00962-7
Precision medicine for human cancers with Notch signaling dysregulation (Review).
Katoh M, Katoh M. · · 2020 · cited 159× · PMID 31894255 · DOI 10.3892/ijmm.2019.4418
Stepping forward in antibody-drug conjugate development.
Jin Y, Schladetsch MA, Huang X, Balunas MJ, et al · · 2022 · cited 136× · PMID 34171334 · DOI 10.1016/j.pharmthera.2021.107917
Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study.
Farooq AV, Degli Esposti S, Popat R, Thulasi P, et al · · 2020 · cited 133× · PMID 32712806 · DOI 10.1007/s40123-020-00280-8
Longer term outcomes with single-agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13-month follow-up from the pivotal DREAMM-2 study.
Lonial S, Lee HC, Badros A, Trudel S, et al · · 2021 · cited 112× · PMID 34314018 · DOI 10.1002/cncr.33809

Verify or expand the search:

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma · Phase 1 · recruiting
NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma · Phase 1 · recruiting
NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma · Phase 2 · recruiting
NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma · Phase 2 · recruiting
NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With · Phase 3 · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03525678 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 3 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03525678.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing