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Not Yet Recruiting NCT05714839

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

Conditions: Multiple Myeloma

Sex: All
Ages: 18 Years – N/A
Phase: PHASE1, PHASE2
Enrollment: 124
Sponsor: GlaxoSmithKline

Summary

The study consists of three partsPart 1: The primary purpose of this part is to determine the safety, and recommended part 2 dose of belantamab (bela) in participants with relapsed or refractory multiple myeloma (RRMM).Part 2: The primary purpose of this part is to determine safety, tolerability and percentage of adverse events (AEs) that happen to eyes in participants with RRMM treated with bela in combination with other treatments.Part 3: The primary objective of this part is to assess the safety, tolerability and rate of ocular AEs in participants with transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) treated with either belantamab mafodotin (belamaf) or bela in combination with other treatments.

Eligibility Criteria

Inclusion Criteria:Participants at the time of signing the Informed Consent Form (ICF) are at least 18 years old or are of the legal age of consent in the jurisdiction in which the study is taking place.Participants who have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the IMWG, and measurable disease.PART 1: Participants who have received at least 3 prior lines of anti-myeloma treatments, and have already received an immunomodulating agent, a proteasome inhibitor, and an anti-CD38 mAb (unless contraindicated or unavailable). Lines of therapy are defined by consensus panel of the International Myeloma Workshop.PART 2: Participants who meet all of the following:Have undergone Autologous stem cell transplant (ASCT) or are considered transplant ineligibleHave been previously treated with at least ONE prior line of MM therapyHave documented disease progression during or after their most recent therapyPART 3: Participants who meet both of the following:NDMM with a requirement for treatment as documented per IMWG criteriaNot considered a candidate for high dose chemotherapy with ASCT due to:Age ≥ 65 years ORAge 18-65 years with presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT or who refuse high-dose chemotherapy with ASCT as an initial treatment.Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and protocol.Exclusion Criteria:Diagnosis of primary Amyloid Light chain (AL) Amyloidosis, active Polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes (POEMS) syndrome, primary plasma cell leukemia.Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance with study procedures.Active infection requiring antibiotic, antiviral, or antifungal treatment.Known, current drug or alcohol abuse.Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this trial, unless prospective Independent Review Board (IRB) approval (by chair or designee) is allowing exception to this criterion for a specific participant.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05714839). StuddyBuddy aggregates publicly available trial information.