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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
GlaxoSmithKline
Study ID
NCT03525678
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belantamab mafodotin frozen liquid — DRUG
    Belantamab mafodotin will be available as frozen liquid. Frozen liquid will be available as 30 milligram (mg)/vial solution in a single use vial with unit dose strength of 2.5 or 3.4 mg/kg. Belantamab mafodotin will be administered as IV solution over at least 30 minutes. Frozen belantamab mafodotin will be diluted in 0.9 percent saline and administered via infusion pump.
  • Belantamab mafodotin lyophilized powder — DRUG
    Belantamab mafodotin will be available as lyophilized powder. Lyophilized powder will be available as 100 mg/vial in single-use vial for reconstitution with unit dose strength of 3.4 mg/kg. Lyophilized belantamab mafodotin will be reconstituted using water for injection and diluted with saline before use.

Study Details

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.

Key Dates

Start date
Jun 18, 2018
Status verified
Aug 2025
Primary completion
Jun 21, 2019
Completion
Sep 12, 2024

Study Design

Enrollment
221 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants receiving frozen 2.5 mg/kg belantamab mafodotin
    Participants will receive 2.5 mg/kg frozen liquid belantamab mafodotin. Participants will be administered with frozen liquid belantamab mafodotin via infusion pump every 3 weeks.
  • Experimental: Participants receiving frozen 3.4 mg/kg belantamab mafodotin
    Participants will receive 3.4 mg/kg frozen liquid belantamab mafodotin. Participants will be administered with frozen liquid belantamab mafodotin via infusion pump every 3 weeks.
  • Experimental: Participants receiving lyophilized belantamab mafodotin
    Participants in lyophilized arm will receive lyophilized belantamab mafodotin once lyophilized configuration becomes available and enrollment has been completed for frozen liquid arms.

Primary Outcome Measure

Overall Response Rate (ORR) by Independent Review Committee (IRC) (Full Analysis Population) [ Time Frame: Up to 48 weeks ]

Locations (21)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteNew HavenConnecticut06510-
GSK Investigational SiteAtlantaGeorgia30322-
GSK Investigational SiteAtlantaGeorgia30342-
GSK Investigational SiteChicagoIllinois60612-
GSK Investigational SiteChicagoIllinois60637-
GSK Investigational SiteIndianapolisIndiana46202-
GSK Investigational SiteFairwayKansas66205-
GSK Investigational SiteBaton RougeLouisiana70121-
GSK Investigational SiteBaltimoreMaryland21201-
GSK Investigational SiteBostonMassachusetts02215-
GSK Investigational SiteRochesterMinnesota55905-
GSK Investigational SiteNew YorkNew York10029-
GSK Investigational SiteNew YorkNew York10065-
GSK Investigational SiteCharlotteNorth Carolina28204-
GSK Investigational SiteColumbusOhio43210-
GSK Investigational SitePhiladelphiaPennsylvania19104-
GSK Investigational SiteNashvilleTennessee37232-
GSK Investigational SiteHoustonTexas77030-
GSK Investigational SiteSalt Lake CityUtah84112-
GSK Investigational SiteSeattleWashington98109-
GSK Investigational SiteMadisonWisconsin53792-

Find similar trials in New Haven, CT

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
GSK Investigational Site· New Haven, CTGSK Investigational Site· Atlanta, GAGSK Investigational Site· Chicago, ILGSK Investigational Site· Indianapolis, INGSK Investigational Site· Fairway, KSGSK Investigational Site· Baton Rouge, LA

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