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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belantamab mafodotin+Bortezomib+dexamethasone (BVd) | Participants receiving belantamab and dexametahsone plus the proteasome inhibitor Bortezomib as salvage therapy in first or second MM relapse. |
| |
| Belantamab mafodotin+Pomalidomide-dexamethason (BPd) | Participants receiving belantamab and dexametahsone plus the inmunomadulatory drug Pomalidomide as salvage therapy in first or second MM relapse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belantamab mafodotin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient year of birth | Measured in date (year) | 18 months |
| Patient sex | Measured in male vs female | 18 months |
| Patient weight | Measured in kilograms | 18 months |
| Disease diagnosis date | Measured in date (dd/mm/yyyy) | 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. | 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. | 18 months |
| Disease type of immunoglobulin | Measures the type of immunoglobuline secreted by MM tumour cells (IgG, IgA, IgD, IgE or IgM) |
| Measure | Description | Time Frame |
|---|---|---|
| Type of treatment (BVd or BPd) | Defined as which belantamab combination the patient received (Belantamab+Bortezomib+dexamethasone [BVd], or Belantaman+Pomalidomide+dexamethaspone [BPd]) | 18 months |
| Disease comorbidities |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 months |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carmen López-Carrero | Contact | +34916 26 62 32 | carmen@fundacionpethema.es |
| Name | Affiliation | Role |
|---|---|---|
| Javier de la Rubia | Hospital Universitario La Fe | Study Chair |
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| ID | Term |
|---|---|
| C000631691 | belantamab mafodotin |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| C467566 | pomalidomide |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| Bortezomib | Drug | 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. |
|
| Dexamethasone | Drug | 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. |
|
| Pomalidomide | Drug | 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. |
|
| 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
| 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 | 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). | 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:
| 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. | 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. | 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. | 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). | 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) | 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. | 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. | 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). | 18 months |
| Disease first line treatment | First line treatment refers to the treatment the patient received at diagnosis (in de novo MM status) | 18 months |
| Disease date of first relapse | Measured in date (dd/mm/yyyy) | 18 months |
| Disease date of second line treatment (if applies) | Measured in date (dd/mm/yyyy) | 18 months |
| Disease date of second relapse (if applies) | Measured in date (dd/mm/yyyy) | 18 months |
| Patient comorbidities | This outcome will annotate the patients' medical history before administering any belantamab combination including:
| 18 months |
The appearance of any of the following will be annotated:
| 18 months |
| Date of drug infusion/administration | Measured in dd/mm/yyyy for each drug of the belantamab combinations | 18 months |
| Drug dose | The dose of each drug of the belantamab combinations will be annotated | 18 months |
| Dose reduction | Dose reductions for each drug of the belantamab combinations will be annotated | 18 months |
| Reason for dose reduction | The reason for dose reductions for each drug of the belantamab combinations will be annotated | 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 | 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 | 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. | 18 months |
| 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. |
| 18 months |
| 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. | 18 months |
| 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. | 18 months |
| Survival data, Progression-free survival 2 | Defined as time from the first infusion of belantamab mafodotin to the date of disease progression (second relapse) or death (whichever occurs first), documented after initiation of new anti-myeloma therapy. | 18 months |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |