A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed / Refractory Multiple Myeloma - DREAMM-6

R
Rafat Abonour, MD

Primary Investigator

Overview

This is a 2-part study, where Part 1 will be dose-escalation phase and Part 2 will be dose expansion phase. Part 1 will first evaluate the safety and tolerability profile of 2 doses of GSK2857916, when administered in combination with approved regimens of either lenalidomide plus dexamethasone (Arm A) or bortezomib plus dexamethasone (Arm B) and will identify a recommended Phase 2 dose (RP2D) for each combination treatment (Part 1). Part 2 of the study will evaluate the clinical activity at the RP2D for GSK2857916 in combination with lenalidomide plus dexamethasone (Arm A) or bortezomib plus dexamethasone (Arm B) in additional subjects with RRMM.

Description

A total of 90 evaluable subjects will be enrolled in the study of which up to 24 will be included in Part 1 and up to 66 will be included in Part 2. Subjects receiving treatment A, may continue combination treatment until the occurrence of PD, intolerable (AEs), consent withdrawal, or death. The subjects receiving treatment B, may continue combination treatment for a total of up to 8 cycles. After 8 cycles of combination therapy, the subjects will continue treatment with GSK2857916, as monotherapy until PD, intolerable AEs, consent withdrawal, or death.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Multiple Myeloma
  • Age: Between 18 Years - 100 Years
  • Gender: All

Inclusion Criteria
Have confirmed diagnosis of Multiple Myeloma
Have undergone stem cell transplant (SCT), or are considered transplant ineligible
Have been previously treated with at least 1 prior line of MM therapy, and must have documented disease progression during or after their most recent therapy according to the IMWG criteria.
Must have at least ONE aspect of measurable disease
Exclusion Criteria
Systemic anti-myeloma therapy (including systemic steroids) within 14 days, or plasmapheresis within 7 days prior to the first dose of study drug
Use of an investigational drug within 14 days or five half-lives (whichever is longer) preceding the first dose of study drug
Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs
Prior allogenic stem cell transplant
Evidence of active mucosal or internal bleeding
Any major surgery within the last four weeks
Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect subject's safety). Subjects with isolated proteinuria resulting from MM are eligible, provided they fulfill criteria
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures
Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease per investigator's assessment)
Subjects with previous or concurrent malignancies are allowed only if the second tumor is not contributing to the subject's illness. The subject must not be receiving active therapy, other than hormonal therapy for this disease and the disease must be considered medically stable for at least 2 years
Pregnant or lactating female
Active infection requiring treatment
Known HIV infection
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)
Current corneal disease except for mild punctuate keratopathy
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. NOTE: Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained

Updated on 13 Apr 2023. Study ID: 1807284744 (207497)

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