Last updated 31 days ago
A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments
48 patients around the world
Available in Brazil, Argentina, Mexico
GlaxoSmithKline
2Research sites
48Patients around the world
This study is for people with
Multiple myeloma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
DOM Centro de Reumatología - CABA
Recruiting
Sanatorio Nuestra Señora del Pilar - Bs As
Recruiting
StudyDREAMM-20
SponsorGlaxoSmithKline
Conditions
Multiple myeloma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05714839
