A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Subjects With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody

Official Title

A Phase II, Open Label, Randomized, Two-Arm Study to Investigate the Efficacy and Safety of Two Doses of the Antibody Drug Conjugate GSK2857916 in Participants With Multiple Myeloma Who Had 3 or More Prior Lines of Treatment, Are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed an Anti-CD38 Antibody (DREAMM 2)

Summary:

Multiple myeloma (MM) is an incurable malignancy and accounts for 1 percentage of all cancers and for 10% of all hematologic malignancies. Subjects with relapsed/refractory multiple myeloma (RRMM) will be included in this study, to evaluate the efficacy and safety of GSK2857916 monotherapy. Subjects will be treated with GSK2857916 monotherapy until disease progression or unacceptable toxicity and will be followed for Progression Free Survival (PFS) and Overall survival (OS). The subjects will be randomized to receive either frozen GSK2857916 at the dose of 2.5 milligram per kilogram (mg/kg) or 3.4 mg/kg Intravenous (IV). There will be an independent cohort of subjects who will receive a lyophilized configuration of GSK2857916. Approximately 155 subjects will be enrolled in the study of which 130 subjects will be enrolled to receive frozen GSK2857916 and 25 subjects will be enrolled in the independent lyophilized drug product cohort. The subjects 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.

Trial Description

Primary Outcome:

  • Overall response rate (ORR)
Secondary Outcome:
  • Clinical benefit rate (CBR)
  • Duration of response (DoR)
  • Time to response
  • Progression free survival
  • Time to progression
  • Overall survival
  • Number of subjects with abnormal hematology parameters
  • Number of subjects with abnormal clinical chemistry parameters
  • Number of subjects with abnormal physical examination parameters
  • Number of subjects with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP) assessment
  • Number of subjects with abnormal pulse rate
  • Number of subjects with abnormal body temperature
  • Number of subjects with adverse events (AEs), serious AEs (SAEs) and AEs of special interest (AESI)
  • Number of subjects with abnormal ocular findings
  • Area under the curve (AUC) of GSK2857916
  • Maximum plasma concentration (Cmax) of GSK2857916
  • Time of occurrence of Cmax (Tmax) of GSK2857916
  • Terminal phase half-life (T1/2) of GSK2857916
  • Incidence and titers of anti-drug antibodies (ADAs)
  • Number of subjects with symptomatic AEs measured by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
  • Number of subjects with symptomatic AEs measured by National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25)
  • Number of subjects with symptomatic AEs measured by Ocular Surface Disease Index (OSDI)
  • Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core module (EORTC QLQ-C30) score
  • Change in EORTC QLQ- 20-item Multiple Myeloma module (MY-20) score

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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