Relapse Multiple Myeloma
Conditions
Keywords
belantamab mafodotin
Brief summary
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
DRUGBelantamab 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.
DRUGBortezomib
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.
DRUGDexamethasone
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.
DRUGPomalidomide
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.
Sponsors
PETHEMA Foundation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient year of birth | 18 months | Measured in date (year) |
| Patient sex | 18 months | Measured in male vs female |
| Patient weight | 18 months | Measured in kilograms |
| Disease diagnosis date | 18 months | Measured in date (dd/mm/yyyy) |
| Disease Interational Score System status at diagnosis | 18 months | 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. |
| Disease type of MM (secretory or oligosecretory) | 18 months | 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. |
| Disease type of immunoglobulin | 18 months | Measures the type of immunoglobuline secreted by MM tumour cells (IgG, IgA, IgD, IgE or IgM) |
| Disease ECOG status | 18 months | 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 |
| Disease extramedullar disease at relapse | 18 months | Extramedullary disease is defined as an aggressive form of multiple myeloma characterized by the presence of soft-tissue plasmacytomas that result from hematogenous spread |
| Disease presentation of plasma cell leukemia | 18 months | 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). |
| Disease high-risk | 18 months | 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 |
| Disease kidney function pre-belantamab infusion by creatinine clearance | 18 months | 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. |
| Disease kidney function pre-belantamab infusion by serum creatinine | 18 months | 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. |
| Disease kidney failure at disease progression | 18 months | 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. |
| Disease tumoral load pre-belantamab infusion by circulating cells | 18 months | 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). |
| Disease tumoral load pre-belantamab infusion by serum beta-2-microglobulin | 18 months | Tumoral load refers to the amount of disease detected at any time. It will be measured by serum beta-2-microglobulin levels (mg/L) |
| Disease presence of lytic lesions | 18 months | 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. |
| Disease previous anti-MM treatments | 18 months | Annotation of the treatments received by each patient before the treatment with belantamab combinations analyzed in this study. |
| Disease number of previous anti-MM treatments and treatment response | 18 months | 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). |
| Disease first line treatment | 18 months | First line treatment refers to the treatment the patient received at diagnosis (in de novo MM status) |
| Disease date of first relapse | 18 months | Measured in date (dd/mm/yyyy) |
| Disease date of second line treatment (if applies) | 18 months | Measured in date (dd/mm/yyyy) |
| Disease date of second relapse (if applies) | 18 months | Measured in date (dd/mm/yyyy) |
| Patient comorbidities | 18 months | This outcome will annotate the patients' medical history before administering any belantamab combination including: * Lung disease * Heart disease * Diabetes * Other |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type of treatment (BVd or BPd) | 18 months | Defined as which belantamab combination the patient received (Belantamab+Bortezomib+dexamethasone \[BVd\], or Belantaman+Pomalidomide+dexamethaspone \[BPd\]) |
| Disease comorbidities | 18 months | 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 | 18 months | Measured in dd/mm/yyyy for each drug of the belantamab combinations |
| Drug dose | 18 months | The dose of each drug of the belantamab combinations will be annotated |
| Dose reduction | 18 months | Dose reductions for each drug of the belantamab combinations will be annotated |
| Reason for dose reduction | 18 months | The reason for dose reductions for each drug of the belantamab combinations will be annotated |
| Drug delay | 18 months | The time frame (in days) of any drug delay between drug doses for each drug of the belantamab combinations will be annotated |
| New interval between doses | 18 months | The new time frame (in days) between doses of any drug for each drug of the belantamab combinations will be annotated |
| Survival data, Overall response rate | 18 months | 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. |
Contacts
CONTACTCarmen López-Carrero
STUDY_CHAIRJavier de la Rubia
Hospital Universitario La Fe
Outcome results
None listed