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A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination with Pomalidomide and Dexamethasone (B-Pd) versus Pomalidomide plus Bortezomib and Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma (DREAMM 8)

A Phase III Study of Belantamab Mafodotin plus Pomalidomide and Dexamethasone vs Pomalidomide, Bortezomib and Dexamethasone in Participants with RRMM (DREAMM 8)

Ishibashi Hideyasu

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

jp.gskjrct@gsk.com

Ishibashi Hideyasu

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

+81-120-561-007

jp.gskjrct@gsk.com

Not Recruiting

Oct. 01, 2021

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

-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.

Both

Relapsed/Refractory Multiple Myeloma

Belantamab mafodotin will be administered intravenously (IV) at a single dose of 2.5 mg/kg on Day 1 (D1) of Cycle 1 and 1.9 mg/kg in Cycle 2 and beyond (2+) of every 28-day cycle

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

+81-11-706-7061

June. 15, 2021

No

USA/Canada/Italy/Spein/Poland/Turkey/France/Czech Republic/Germany/Israel/UK/Russia/Greece/Korea/Australia/New Zealand