A Phase III Study of Belantamab Mafodotin plus Pomalidomide and Dexamethasone vs Pomalidomide, Bortezomib and Dexamethasone in Participants with RRMM (DREAMM 8)
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Registration Number
- jRCT2011210067
- Lead Sponsor
- GlaxoSmithKline K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 20
-18 years or older (at the time consent is obtained) -Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 -Have undergone autologous stem cell transplant (SCT) or are considered transplant ineligible. -Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen (lenalidomide must have been administered for at least 2 consecutive cycles) and must have documented disease progression during or after their most recent therapy. -Adequate organ system functions as defined by the laboratory assessments listed in study protocol
- Active plasma cell leukemia at the time of screening. Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin changes).
- Systemic anti-myeloma therapy (including chemotherapy and systemic steroids) or use of an investigational drug 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.
- Received prior treatment with or intolerant to pomalidomide
- Received prior BCMA targeted therapy
- Plasmapheresis within 7 days prior to the first dose of study drug.
- Participants after prior allogeneic SCT.
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) defined as the time from the date of randomization until the earliest date of documented disease progression or death due to any cause
- Secondary Outcome Measures
Name Time Method