Study to Evaluate Efficacy and Safety of Belantamab-based Combinations for Relapsed Multiple Myeloma

NCT07637526 | Not Yet Recruiting FDA Drug

• 1 other identifier: GEM-BELACOMBOS
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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. The main question it aims to answer is which belantamab combinations (belantamab mafodotin+bortezomib+dexamethasone \[BVd\] vs. belantamab mafodotin+pomalidomide+dexamethasone \[BPd\]) show higher response rates in patients with MM in first or second relapse.

Conditions

Relapse Multiple Myeloma

Keywords

belantamab mafodotin

Outcome Measures

Primary Outcomes (23)

• 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)

  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

  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 genetic risk

  This outcome aims to annotate if the participant has high-genetic risk MM. 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

  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 relapse (if applies)

  Measured in date (dd/mm/yyyy)

  18 months

• Disease date of second line treatment (if applies)

  Measured in date (dd/mm/yyyy)

  18 months

Secondary Outcomes (14)

• Type of treatment (BVd or BPd)

  18 months

• Incidence, grade and duration of side effects of belantamab mafodotin combinations (BVd and BPd) under compasionate use conditions

  18 months

• Disease comorbidities

  18 months

• Date of drug infusion

  18 months

• Drug dose

  18 months

Study Arms (2)

Belantamab mafodotin+Bortezomib+dexamethasone (BVd)

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

Belantamab mafodotin+Pomalidomide-dexamethason (BPd)

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

Interventions

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.

Belantamab mafodotin+Bortezomib+dexamethasone (BVd); Belantamab mafodotin+Pomalidomide-dexamethason (BPd)

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.

Belantamab mafodotin+Bortezomib+dexamethasone (BVd)

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.

Belantamab mafodotin+Bortezomib+dexamethasone (BVd); Belantamab mafodotin+Pomalidomide-dexamethason (BPd)

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.

Belantamab mafodotin+Pomalidomide-dexamethason (BPd)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with Multiple Myeloma treated with combinations of belantamab mafodotin at first or second relapse, or refractory disease, not being in fourth or more lines of treatment.

You may qualify if:

• Confirmed diagnosis of relaps/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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PETHEMA Foundation: lead

MeSH Terms

Interventions

belantamab mafodotin; Bortezomib; Dexamethasone; pomalidomide

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Javier de la Rubia

  Hospital Universitario La Fe

  STUDY CHAIR

Central Study Contacts

Carmen López-Carrero

CONTACT

+34916 26 62 32; carmen@fundacionpethema.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share