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Belantamab mafodotin plus pomalidomide and dexamethasone (Pd) versus vortezomib plus Pd in relapsed/refractory multiple myeloma (DREAMM 8)

Description

This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple myeloma (RRMM).

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this study is progression-free survival.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Accepting patients who meet these criteria:

  • Capable of giving signed informed consent.
  • Male or female, 18 years or older.
  • Have a confirmed diagnosis of multiple myeloma (MM) as defined by the IMWG criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen and must have documented disease progression during or after their most recent therapy.
  • Must have at least 1 aspect of measurable disease defined as one of the following;
    • Urine M-protein excretion >=200 mg per 24-hour, or
    • Serum M-protein concentration >=0.5 grams per deciliter, or
    • Serum free light chain (FLC) assay: involved FLC level >=10 mg per deciliter and an abnormal serum free light chain ratio (<0.26 or >1.65) only if participant has no measurable urine or serum M spike.
  • Have undergone autologous stem cell transplant (SCT) or are considered transplant ineligible. Participants with a history of autologous SCT may be eligible for study participation.
  • All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE] version 5.0) must be <=Grade 1 at the time of enrolment, except for alopecia.
  • Adequate organ system functions.
  • Male and female participants agree to abide by protocol-defined contraceptive requirements.

Declining patients who meet these criteria:

  • Active plasma cell leukemia, symptomatic amyloidosis or active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin changes (POEMS) syndrome at the time of screening.
  • Prior allogeneic SCT.
  • Systemic anti-myeloma therapy (including chemotherapy and systemic steroids) within 14 days or five half-lives (whichever is shorter) preceding the first dose of study drug; prior treatment with a monoclonal antibody drug within 30 days of receiving the first dose of study drugs.
  • Plasmapheresis within 7 days prior to the first dose of study drug.
  • Received prior treatment with or intolerant to pomalidomide.
  • Received prior Beta cell maturation antigen (BCMA) targeted therapy.
  • Intolerant to bortezomib or refractory to bortezomib (for example; participant experienced progressive disease during treatment, or within 60 days of completing treatment, with a bortezomib-containing regimen of 1.3 mg/ m^2 twice weekly).
  • Evidence of cardiovascular risk including any of the following;
    • Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram abnormalities including second degree (Mobitz type II) or third degree atrioventricular (AV) block.
    • Recent history within (3 months of screening) of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting
    • Class III or IV heart failure as defined by the New York Heart Association functional classification system
    • Uncontrolled hypertension
  • Any major surgery within the last 4 weeks
  • Previous or concurrent invasive malignancy other than multiple myeloma, except:
    • The disease must be considered medically stable for at least 2 years, or
    • The participant must not be receiving active therapy, other than hormonal therapy for this disease
  • Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment
  • Evidence of active mucosal or internal bleeding
  • Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice
  • Active infection requiring treatment
  • Known human immunodeficiency virus (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
  • Positive hepatitis C antibody test result or positive hepatitis ribonucleic acid test result at screening or within 3 months prior to first dose of study treatment
  • Intolerance or contraindications to anti-viral prophylaxis
  • Presence of active renal conditions (such as infection, severe renal impairment requiring dialysis or any other condition that could affect participant's safety)
  • Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain
  • Active or history of venous thromboembolism within the past 3 months
  • Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophylaxis
  • Current corneal disease except for mild punctate keratopathy
  • 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 to the study procedures
  • Pregnant or lactating female
     

Accepting new patients

 

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