Détails de l'étude

Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma (DREAMM 14)

Phase III

Type de maladie :
Traitement :
Population :
Rechute et réfractaire, Première ligne
Immunothérapie
Adultes
  • Participant must be 18 years of age inclusive at the time of signing the informed consent form (ICF).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Histologically or cytologically confirmed diagnosis of MM and a. Has undergone stem cell transplant or is considered transplant ineligible, and b. Has failed at least 3 prior lines of anti-MM therapies, including an anti-cluster of differentiation (CD)38 antibody (e.g., daratumumab) alone or in combination and is refractory to an immunomodulatory agent (e.g., lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib).
  • Participant has measurable disease per modified IMWG criteria.
  • Life expectancy of at least 6 months, in the opinion of the investigator.
  • Male and female participants agree to abide by protocol-defined contraceptive requirements.
  • Participant is capable of giving signed informed consent.
  • Participant meets country-specific inclusion criteria described in the protocol.
  • Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes), or active plasma cell leukemia at the time of screening.
  • Current corneal epithelial disease, except nonconfluent superficial punctate keratitis (SPK).
  • Evidence of active mucosal or internal bleeding.
  • Presence of an active renal condition.
  • Any serious and/or unstable pre-existing medical condition, psychiatric disorder, or other conditions that could interfere with the participant’s safety, obtaining informed consent, or compliance with the study procedures.
  • Malignancies other than the disease under study, except for any other malignancy from which the participant has been disease free for >2 years and, will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy (MM). Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.
  • Evidence of cardiovascular risk as per the protocol criteria.
  • Pregnant or lactating female.
  • Active infection requiring antibiotic, antiviral, or antifungal treatment.
  • Known human immunodeficiency virus (HIV) infection, unless the criteria in protocol can be met.
  • Hepatitis B and C will be excluded unless the criteria in protocol can be met.
  • Cirrhosis or current unstable liver or biliary disease.
  • Alanine aminotransferase (ALT) >2.5× upper limit of normal (ULN).
  • Total Bilirubin >1.5×ULN.
  • Systemic anti-MM therapy within <=14 days or 5 half-lives, whichever is shorter.
  • Systemic therapy with high dose steroids within <=14 days before the first dose of study treatment.
  • Prior allogenic stem cell transplant.
  • Prior treatment with a monoclonal antibody <=30 days before the first dose of study treatment.
  • Prior treatment with an anti-B cell maturation antigen (BCMA) targeted therapy or hypersensitivity reactions to any components of the study treatment..
  • Treatment with an antibody-drug conjugate.
  • Participant has received any major surgery <=4 weeks before the first dose of study treatment. An exception may be allowed for bone stabilizing surgery after consultation with the GSK medical director.
  • Inadequate bone marrow reserve or organ functions as demonstrated by any of the following: a. Absolute neutrophil count <1.0×10^9/L, b. Hemoglobin <8 gram/deciliter (g/dL), c. Platelet count <50×10^9/L, d. Spot urine (albumin/creatinine ratio) >500 milligram/gram (mg/g), e. Estimated glomerular filtration rate (eGFR) <30 milliliter per minute per 1.73 meter square (mL/min/1.73m^2).

Hôpital du Sacré-Cœur de Montréal

Investigateur principal : Dr Jean-Samuel Boudreault
Infirmière de recherche : Marie-Anne Capobianco

Contact
Courriel : jeansamuelboud@gmail.com