The goal of this retrospective observational study is to characterize multiple myeloma (MM) patients (by collecting demographics, disease characteristics and treatment history data) treated in first or second relapse with belantamab mafodotin combinations under compassionate use conditions.
Confirmed diagnosis of relapsed/refractory MM.
Having received at least one dose of a belantamab mafodotin combination (BVd or BPd) under compassionate use conditions as treatment for a first or second relapse.
Patients ≥18 years of age at the start of treatment with the belantamab mafodotin combination (BVd or BPd) under compassionate use conditions.
Any patient who has received a belantamab mafodotin combination (BVd or BPd) under compassionate use conditions in fourth line of treatment or later will be excluded from the study.
Adult patients with Multiple Myeloma treated under compassionate use with combinations of Belantamab Mafodotin at first or second relapse, or refractory disease, not being in fourth or more lines of treatment.
Cohort
Retrospective
Belantamab mafodotin
DrugAll participants evaluated in this study must have received this drug as salvage therapy in first or second relapse. Doses, dose reductions, increased spacing between doses and number of total infusions will be recorded.
Bortezomib
DrugParticipants in BVd arm must have received this drug in combination with belantamab mafodotin in first or second relapse. Doses, dose reductions, increased spacing between doses and number of total infusions will be recorded.
Dexamethasone
DrugAll participants evaluated in this study must have received this drug as salvage therapy in first or second relapse. Doses, dose reductions, increased spacing between doses and number of total infusions will be recorded.
Pomalidomide
DrugParticipants in BPd arm must have received this drug in combination with belantamab mafodotin in first or second relapse. Doses, dose reductions, increased spacing between doses and number of total infusions will be recorded.
Patient year of birth
Measured in date (year)
Patient sex
Measured in male vs female
Patient weight
Measured in kilograms
Disease diagnosis date
Measured in date (dd/mm/yyyy)
Type of treatment (BVd or BPd)
Defined as which belantamab combination the patient received (Belantamab+Bortezomib+dexamethasone \[BVd\], or Belantaman+Pomalidomide+dexamethaspone \[BPd\])
Disease comorbidities
The appearance of any of the following will be annotated: * Hypercalcemia * Kidney failure * Anemia * Bone problems, such as osteoporosis, bone pain, and fractures
Date of drug infusion/administration
Measured in dd/mm/yyyy for each drug of the belantamab combinations
Drug dose
The dose of each drug of the belantamab combinations will be annotated
Incidence, grade and duration of side effects of belantamab mafodotin combinations (BVd and BPd) under compasionate use conditions
Data on incidence, grade, duration and type of infections will be collected, as well as the proportion of participants who required inmunoglobulin treatment during BVd or BPd.
Survival data, Duration of response
Defined as the time from first documented evidence of partial response or better to disease progression or death, among patients who achieved confirmed partial response or better.
Survival data, Progression-free survival
Defined as defined as the time in months from the first belantamab mafodotin infusion to the date of the first documented disease progression or death, whichever occurs first.
Survival data, Overall Survival
Defined as defined as the time from the first infusion of belantamab mafodotin (start date) until the date of death from any cause.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
