An observational study in Relapse Multiple Myeloma, sponsored by PETHEMA Foundation. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by PETHEMA Foundation · Observational
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:
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 100 is below the median of 150 across 486 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →PETHEMA Foundation is the lead sponsor of 107 studies on the registry; 12 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receiving belantamab and dexametahsone plus the proteasome inhibitor Bortezomib as salvage therapy in first or second MM relapse.
Drug: Belantamab mafodotin · Drug: Bortezomib · Drug: Dexamethasone
Participants receiving belantamab and dexametahsone plus the inmunomadulatory drug Pomalidomide as salvage therapy in first or second MM relapse.
Drug: Belantamab mafodotin · Drug: Dexamethasone · Drug: Pomalidomide
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.
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.
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 18 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Dec 2027, 18 months later.
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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