Study to Evaluate Efficacy and Safety of Belantamab-based Combinations for Relapsed Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Belantamab mafodotin, Bortezomib, Dexamethasone, Pomalidomide.
- Who it may be relevant to
- Registry conditions: Relapse Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Retrospective Observational Study to Evaluate the Effectiveness and Safety of Belantamab Mafodotin-based Combinations (Belantamab Mafodotin, Bortezomib, Dexamethasone [BVd] or Belantamab Mafodotin, Pomalidomide, Dexamethasone [BPd]) Used as Compassionate Use in Patients With Multiple Myeloma in First or Second Relapse
Overview
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.
Detailed description
This retrospective observational study will collect data from MM patients at first or second relapse to evaluate the response rates under belantamab mafodotin-based therapeutic schedules as salvage therapy.
Data from participants either treated with belantamab mafodotin+bortezomib+dexamethasone \[BVd\] or belantamab mafodotin+pomalidomide+dexamethasone \[BPd\] schedules will be evaluated. Data collection will include the following data:
* Sociodemographics (demographic data, disease status and clinical chracteristics). * Medical history (MM diagnosis, disease characteristics and history of prior treatment with anti-MM therapies). * Treatment with BVd or BPd (overall response rate, duration of response, progression-free survival at diagnosis, progression-free survival at relapse, duration of the treatment, overall survival, side effects, infections and concomitant treatments during the treatment with belantamab-based schedules).
Interventions
- Drug Belantamab mafodotin
All 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. - Drug Bortezomib
Participants 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. - Drug Dexamethasone
All 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. - Drug Pomalidomide
Participants 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.
Primary outcome measures
- Patient year of birth [Time frame: 18 months]
- Patient sex [Time frame: 18 months]
- Patient weight [Time frame: 18 months]
- Disease diagnosis date [Time frame: 18 months]
- Disease Interational Score System status at diagnosis [Time frame: 18 months]
- Disease type of MM (secretory or oligosecretory) [Time frame: 18 months]
- Disease type of immunoglobulin [Time frame: 18 months]
- Disease ECOG status [Time frame: 18 months]
- Disease extramedullar disease at relapse [Time frame: 18 months]
- Disease presentation of plasma cell leukemia [Time frame: 18 months]
Secondary outcome measures (9)
- Type of treatment (BVd or BPd) [Time frame: 18 months]
- Disease comorbidities [Time frame: 18 months]
- Date of drug infusion/administration [Time frame: 18 months]
- Drug dose [Time frame: 18 months]
- Dose reduction [Time frame: 18 months]
- Reason for dose reduction [Time frame: 18 months]
- Drug delay [Time frame: 18 months]
- New interval between doses [Time frame: 18 months]
- Survival data, Overall response rate [Time frame: 18 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07637526 · GEM-BELACOMBOS