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.
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).
Study Type
OBSERVATIONAL
Enrollment
100
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.
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.
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.
Patient year of birth
Measured in date (year)
Time frame: 18 months
Patient sex
Measured in male vs female
Time frame: 18 months
Patient weight
Measured in kilograms
Time frame: 18 months
Disease diagnosis date
Measured in date (dd/mm/yyyy)
Time frame: 18 months
Disease Interational Score System status at diagnosis
Developed in 2005 by the International Myeloma Working Group (IMWG), it uses two readily available blood tests (serum β2 microglobulin (Sβ2M) and serum albumin) to classify patients into three stages: Stage I: Sβ2M \< 3.5 mg/L; serum albumin ≥ 3.5 g/dL. Stage II: Sβ2M \< 3.5 mg/L; serum albumin \< 3.5 g/dL; or β2M 3.5 to 5.5 mg/L, irrespective of serum albumin. Stage III: Sβ2M \> 5.5 mg/L.
Time frame: 18 months
Disease type of MM (secretory or oligosecretory)
Defined as secretory (when immunoglobulines are detectable in the patient's serum and/or urine) or oligosecretory (when inmunoglobulines are below the treshold shown next). Secretory treshold definition: M-protein≥1 gr/dL, or U-PEP \> 200 mg/24 hours or involved free light chain≥ 100 mg/L.
Time frame: 18 months
Disease type of immunoglobulin
Measures the type of immunoglobuline secreted by MM tumour cells (IgG, IgA, IgD, IgE or IgM)
Time frame: 18 months
Disease ECOG status
The ECOG Performance Status Scale describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Grades: 0: Fully active, able to carry on all pre-disease performance without restriction 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours 3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 5. Dead
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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.
Time frame: 18 months
Disease extramedullar disease at relapse
Extramedullary disease is defined as an aggressive form of multiple myeloma characterized by the presence of soft-tissue plasmacytomas that result from hematogenous spread
Time frame: 18 months
Disease presentation of plasma cell leukemia
Plasma cell leukemia is a rare and aggressive variant of myeloma characterized by the presence of circulating plasma cells; diagnosis is based upon the percentage (≥20%) and absolute number (≥2 × 109/L) of plasma cells in peripheral blood. This outcome aims to annotate if the particpiant has a canonical MM (between 10% and 19% of clonal plasma cells in bone marrow) or the rare leukemized variant of MM, which is also known as plasma cell leukemia (≥20% clonal plasma cells).
Time frame: 18 months
Disease high-risk
This outcome aims to annotate if the participant has high-risk MM. High-risk MM can be measured by a) beta 2-microglobulin (Sβ2M) levels, or by b) tumour genetic alterations: 1. High-risk is considered when Sβ2M\>=5.5mg/L (if creatinin \<1.2mg/dL). 2. High-genetic risk in MM (Avet-Loiseau H J Clin Oncol 2025) is defined as the presence of any of the following: * Deletion of 17p in \>20% of sorted plasma cells * TP53 mutation * Biallelic deletion of 1p32 * 2 alterations of the following: t(4;14), t(14;16) or t(14,20); or Gain/amplification of 1q; or monoallelic del 1p32
Time frame: 18 months
Disease kidney function pre-belantamab infusion by creatinine clearance
This outcome aims to annotate if the participant shows kideny disfunction or impairment at any time during treatment. Kidney or renal impairment is defined as creatinine clearance below 40 mL/min due to myeloma.
Time frame: 18 months
Disease kidney function pre-belantamab infusion by serum creatinine
This outcome aims to annotate if the participant shows kideny disfunction or impairment at any time during treatment. Kidney or renal impairment can also be evaluated by serum creatinine and this happens when serum creatinine is above 2 mg/dL due to myeloma.
Time frame: 18 months
Disease kidney failure at disease progression
This outcome aims to annotate if the participant shows kidney failure at disease progression. Kidney failure is defined as an estimated glomerular filtration rate (eGFR) below 15 mL/min.
Time frame: 18 months
Disease tumoral load pre-belantamab infusion by circulating cells
Tumoral load refers to the amount of disease detected at any time. It will be measured by the number of circulating tumour cells in peripheral blood (cells/L).
Time frame: 18 months
Disease tumoral load pre-belantamab infusion by serum beta-2-microglobulin
Tumoral load refers to the amount of disease detected at any time. It will be measured by serum beta-2-microglobulin levels (mg/L)
Time frame: 18 months
Disease presence of lytic lesions
This outcome aims to annotate if the participant shows bone lytic lesions at any time during treatment. Lytic lesions are lesions that replace normal bone or with a vast proportion showing a lower density or attenuation than the normal bone. These lesions are characterized either by the replacement of bone matrix by other types of tissue including soft tissue, fluid or fat. These lytic lesions are caused by MM cells and are detected and accounted by radiography.
Time frame: 18 months
Disease previous anti-MM treatments
Annotation of the treatments received by each patient before the treatment with belantamab combinations analyzed in this study.
Time frame: 18 months
Disease number of previous anti-MM treatments and treatment response
Annotation of the number of treatments received by each patient before the treatment with belantamab combinations analyzed in this study, and what patients' duration of response was (defined in months).
Time frame: 18 months
Disease first line treatment
First line treatment refers to the treatment the patient received at diagnosis (in de novo MM status)
Time frame: 18 months
Disease date of first relapse
Measured in date (dd/mm/yyyy)
Time frame: 18 months
Disease date of second line treatment (if applies)
Measured in date (dd/mm/yyyy)
Time frame: 18 months
Disease date of second relapse (if applies)
Measured in date (dd/mm/yyyy)
Time frame: 18 months
Patient comorbidities
This outcome will annotate the patients' medical history before administering any belantamab combination including: * Lung disease * Heart disease * Diabetes * Other
Time frame: 18 months
Type of treatment (BVd or BPd)
Defined as which belantamab combination the patient received (Belantamab+Bortezomib+dexamethasone \[BVd\], or Belantaman+Pomalidomide+dexamethaspone \[BPd\])
Time frame: 18 months
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
Time frame: 18 months
Date of drug infusion/administration
Measured in dd/mm/yyyy for each drug of the belantamab combinations
Time frame: 18 months
Drug dose
The dose of each drug of the belantamab combinations will be annotated
Time frame: 18 months
Dose reduction
Dose reductions for each drug of the belantamab combinations will be annotated
Time frame: 18 months
Reason for dose reduction
The reason for dose reductions for each drug of the belantamab combinations will be annotated
Time frame: 18 months
Drug delay
The time frame (in days) of any drug delay between drug doses for each drug of the belantamab combinations will be annotated
Time frame: 18 months
New interval between doses
The new time frame (in days) between doses of any drug for each drug of the belantamab combinations will be annotated
Time frame: 18 months
Survival data, Overall response rate
Defined as the percentage of patients with confirmed partial response or better (i.e., partial response, very good partial response, complte remission, and strict complete response), according to International Myeloma Working Group 2016 or later criteria, if possible, and clinician's notes otherwise.
Time frame: 18 months