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Protocol No. UW19023

Principal Investigator Callander, Natalie

Phase I/II

Age Group Adult

Scope National

Sponsor Type Industry

Title A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study GSK2857916 as monotherapy and in Combination with Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) -- DREAMM 5

Objective We want to find out if GSK2857916 (belantamab mafodotin) is safe when it is combined with other anticancer treatments for multiple myeloma (MM), and to find which doses of belantamab mafodotin and its partner anticancer treatments are better at controlling multiple myeloma than the belantamab mafodotin on its own. Belantamab mafodotin is an investigational drug. This means that the US Food and Drug Administration (FDA) has not approved belantamab mafodotin for the treatment of multiple myeloma (MM), and belantamab mafodotin can only be given in a research study

Treatment
1st part is called Dose Exploration where we will look to find the most safe dose of the BCMA study drug in combination with another anticancer treatment
2nd part is called Cohort Expansion we will use the doses of the BCMA study drug and the other anti-cancer study treatment found to be the most safe and with the best level of response against myeloma in the 1st part.

Description A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study GSK2857916 as monotherapy and in Combination with Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) -- DREAMM 5

Key Eligibility
  • 18 years of age or older
  • Histologically or cytologically confirmed diagnosis of MM
  • Participants who have been treated with at least 3 prior lines of prior anti-myeloma treatments including an IMID (eg. lenalidomide), a proteasome inhibitor (eg. bortezomib) and an anti-CD38 monoclonal antibody
  • History of autologous stem cell transplant are eligible for study, provided the following eligibility criteria are met: transplant was greater than 100 days prior to screening, and no active infection(s)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Measurable disease defined as at least 1 of the following: Serum M-protein greater than or equal to 0.5 g/dL, Urine M-protein greater than or equal to 200 mg/24 hours, Serum free light chain (FLC) assay: Involved FLC level greater than or equal to 10 mg/dL and an abnormal serum FLC ratio (less than 0.26 or greater than 1.65)
  • Adequate organ system functions as defined by the protocol
  • Male and Female of childbearing potential must agree to adequate birth control as defined by the protocol
  • Can not br pregnant or breastfeeding
    EXCLUSION
  • Symptomatic amyloidosis, active ‘polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes’ (POEMS) syndrome, active plasma cell leukemia at the time of screening
  • Current corneal epithelial disease except mild punctate keratopathy
  • Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis
  • Participants with curatively treated non-melanoma skin cancer are not excluded
  • Evidence of cardiovascular risk as defined by the protocol
  • Active infection requiring antibiotic, antiviral, or antifungal treatment
  • Known HIV infection
  • Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction
  • Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study treatment
  • Positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment
  • Patients who have received prior therapy with GSK’916 (belantamab mafodotin)
  • Plasmapheresis within 7 days prior to the first dose of study drug
  • Prior allogeneic transplant is prohibited
  • Patients who have received prior CAR-T therapy with lymphodepletion with chemotherapy within 3 months of screening
  • Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GMCSF], recombinant erythropoietin) within 2 weeks before the first dose of study drug
  • Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions

  • Applicable Disease Sites Multiple Myeloma

    Status Open

    Participating Institutions UW Hospital and Clinics