Relapse Multiple MyelomaGEM-BELACOMBOSNCT07637526
Study to Evaluate Efficacy and Safety of Belantamab-based Combinations for Relapsed Multiple Myeloma
An observational study of Relapse Multiple Myeloma, run by PETHEMA Foundation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapse Multiple Myeloma
- What is being tested?
- Belantamab mafodotin, Bortezomib and Dexamethasone
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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).
- Conditions
- Relapse Multiple Myeloma
- Being tested
- Belantamab mafodotin, Bortezomib, Dexamethasone, Pomalidomide
- Keywords
- belantamab mafodotin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belantamab mafodotinDrug
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.
BortezomibDrug
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.
DexamethasoneDrug
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.
PomalidomideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Belantamab mafodotin+Bortezomib+dexamethasone (BVd) | Participants receiving belantamab and dexametahsone plus the proteasome inhibitor Bortezomib as salvage therapy in first or second MM relapse. Receives: Drug: Belantamab mafodotin; Drug: Bortezomib; Drug: Dexamethasone | |
| Belantamab mafodotin+Pomalidomide-dexamethason (BPd) | Participants receiving belantamab and dexametahsone plus the inmunomadulatory drug Pomalidomide as salvage therapy in first or second MM relapse. Receives: Drug: Belantamab mafodotin; Drug: Dexamethasone; Drug: Pomalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient year of birth
Measured in date (year)
Measured: 18 months
Patient sex
Measured in male vs female
Measured: 18 months
Patient weight
Measured in kilograms
Measured: 18 months
Disease diagnosis date
Measured in date (dd/mm/yyyy)
Measured: 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.
Measured: 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.
Measured: 18 months
Disease type of immunoglobulin
Measures the type of immunoglobuline secreted by MM tumour cells (IgG, IgA, IgD, IgE or IgM)
Measured: 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
- 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
- Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
- Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
- Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
- Dead
Measured: 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
Measured: 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).
Measured: 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:
- High-risk is considered when Sβ2M>=5.5mg/L (if creatinin <1.2mg/dL).
- 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 18 months
Disease first line treatment
First line treatment refers to the treatment the patient received at diagnosis (in de novo MM status)
Measured: 18 months
Disease date of first relapse
Measured in date (dd/mm/yyyy)
Measured: 18 months
Disease date of second line treatment (if applies)
Measured in date (dd/mm/yyyy)
Measured: 18 months
Disease date of second relapse (if applies)
Measured in date (dd/mm/yyyy)
Measured: 18 months
Patient comorbidities
This outcome will annotate the patients' medical history before administering any belantamab combination including:
- Lung disease
- Heart disease
- Diabetes
- Other
Measured: 18 months
Secondary outcomes (9)
Type of treatment (BVd or BPd)
Defined as which belantamab combination the patient received (Belantamab+Bortezomib+dexamethasone [BVd], or Belantaman+Pomalidomide+dexamethaspone [BPd])
Measured: 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
Measured: 18 months
Date of drug infusion/administration
Measured in dd/mm/yyyy for each drug of the belantamab combinations
Measured: 18 months
Drug dose
The dose of each drug of the belantamab combinations will be annotated
Measured: 18 months
Dose reduction
Dose reductions for each drug of the belantamab combinations will be annotated
Measured: 18 months
Reason for dose reduction
The reason for dose reductions for each drug of the belantamab combinations will be annotated
Measured: 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
Measured: 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
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapse Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier de la Rubia, Study chair, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637526
- Sponsor's protocol ID
- GEM-BELACOMBOS
- Acronym
- GEM-BELACOMBOS
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07637526
- Acronym / sponsor ID
- GEM-BELACOMBOS / GEM-BELACOMBOS
- Conditions
- Relapse Multiple Myeloma
- Keywords
- belantamab mafodotin
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Belantamab mafodotin+Bortezomib+dexamethasone (BVd) | – | Drug: Belantamab mafodotin, Drug: Bortezomib, Drug: DexamethasoneParticipants receiving belantamab and dexametahsone plus the proteasome inhibitor Bortezomib as salvage therapy in first or second MM relapse. |
| Belantamab mafodotin+Pomalidomide-dexamethason (BPd) | – | Drug: Belantamab mafodotin, Drug: Dexamethasone, Drug: PomalidomideParticipants receiving belantamab and dexametahsone plus the inmunomadulatory drug Pomalidomide as salvage therapy in first or second MM relapse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Belantamab mafodotinAll 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 | Belantamab mafodotin+Bortezomib+dexamethasone (BVd), Belantamab mafodotin+Pomalidomide-dexamethason (BPd) |
| BortezomibParticipants 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 | Belantamab mafodotin+Bortezomib+dexamethasone (BVd) |
| DexamethasoneAll 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 | Belantamab mafodotin+Bortezomib+dexamethasone (BVd), Belantamab mafodotin+Pomalidomide-dexamethason (BPd) |
| PomalidomideParticipants 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. | Drug | Belantamab mafodotin+Pomalidomide-dexamethason (BPd) |
Primary outcome
Patient year of birth
Time frame: 18 months
Measured in date (year)
Patient sex
Time frame: 18 months
Measured in male vs female
Patient weight
Time frame: 18 months
Measured in kilograms
Disease diagnosis date
Time frame: 18 months
Measured in date (dd/mm/yyyy)
Disease Interational Score System status at diagnosis
Time frame: 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)
Time frame: 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
Time frame: 18 months
Measures the type of immunoglobuline secreted by MM tumour cells (IgG, IgA, IgD, IgE or IgM)
Disease ECOG status
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 18 months
First line treatment refers to the treatment the patient received at diagnosis (in de novo MM status)
Disease date of first relapse
Time frame: 18 months
Measured in date (dd/mm/yyyy)
Disease date of second line treatment (if applies)
Time frame: 18 months
Measured in date (dd/mm/yyyy)
Disease date of second relapse (if applies)
Time frame: 18 months
Measured in date (dd/mm/yyyy)
Patient comorbidities
Time frame: 18 months
This outcome will annotate the patients' medical history before administering any belantamab combination including: * Lung disease * Heart disease * Diabetes * Other
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Javier de la Rubia study chair
Hospital Universitario La Fe
Questions about this trial
What is this clinical trial studying?
An observational study of Relapse Multiple Myeloma, run by PETHEMA Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carmen López-Carrero (+34916 26 62 32, carmen@fundacionpethema.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient year of birth (time frame: 18 months). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.