Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Confirmed diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) criteria.
Previously treated with at least 1 prior line of multiple myeloma (MM) therapy, and must have documented disease progression during or after their most recent therapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Must have at least 1 aspect of measurable disease, defined as one of the following;
1. Urine M-protein excretion \>=200 mg per 24-hour, or
2. Serum M-protein concentration \>=0.5 grams per deciliter (g/dL), or
3. Serum free light chain (FLC) assay: involved FLC level \>=10 mg per dL (\>=100 mg per liter) and an abnormal serum free light chain ratio (\<0.26 or \>1.65).
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 enrollment, except for alopecia.
Adequate organ function
You may not be if
Intolerant to daratumumab.
Refractory to daratumumab or any other anti-CD38 therapy (defined as progressive disease during treatment with anti-CD38 therapy, or within 60 days of completing that treatment).
Intolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m\^2 twice weekly, or within 60 days of completing that treatment). Note: participants with progressive disease during treatment with a weekly bortezomib regimen are allowed.
Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.
Prior treatment with anti-B-cell maturation antigen (anti-BCMA) therapy.
Prior allogenic stem cell transplant.
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain prior malignancies.
Corneal epithelial disease.
Clareo Health | Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
