Belantamab Mafodotin Effectiveness and Safety in Multiple Myeloma (BEAMM-2) in Germany - real-world use, safety, and effectiveness of belantamab mafodotin combination therapies among patients with relapsed / refractory multiple myeloma

Belantamab Mafodotin Effectiveness and Safety in Multiple Myeloma (BEAMM-2) in Germany - real-world use, safety, and effectiveness of belantamab mafodotin combination therapies among patients with relapsed / refractory multiple myeloma - BEAMM-2

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039573

Enrollment

200

Registered

2026-03-25

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C90.0

Interventions

Group 1: Myeloma patients who have already received at least 1 therapy and are receiving an approved therapy combination with Belantamab Mafodotin (Belamaf): either Belamaf, Bortezomib, Dexamethasone

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Confirmed diagnosis of Multiple Myeloma Treatment with Belantamab-Mafodotin according to SMPC signed ICF

Exclusion criteria

Exclusion criteria: enrollment in an interventional clinical trial involving any investigational medicinal product or medical device

Design outcomes

Primary

Measure	Time frame
Characterization of patients with relapsed/refractory MM (2L+), who received real-world treatment with belamaf combination therapies (BVd or BPd), in terms of patient demographics, disease status, clinical characteristics, and treatment history.	—

Secondary

Measure	Time frame
real-world treatment patterns with belamaf combination therapies (BVd or BPd), including, but not limited to, description of starting dose and frequency of treatment, duration, and changes in treatment. To assess the real-world effectiveness of belamaf combination therapies (BVd or BPd), in terms of real-world overall response rate (rwORR), duration of response (DoR), and real-world progression-free survival (rwPFS). further explorative endpoints: real-world effectiveness of belamaf combination therapies (BVd or BPd), in terms of real-world overall survival (rwOS) and rwPFS2, duration of treatment (DoT), rwORR, DoR, rwPFS, rwOS, and rwPFS2 among the following sub-populations: a. Patients who received real-world treatment with an anti-CD38 treatment (e.g., daratumumab or isatuximab) after real-world treatment with belamaf combination therapies (BVd or BPd) b. Patients who received treatment with an anti-CD38 treatment before treatment with belamaf combination therapies (BVd [stratified by 2L or 3L+] or BPd [stratified by 2L or 3L+]) - incidence, severity, and duration of eye-related side effects (ERSEs) and the management steps executed to mitigate them - incidence and grade of infections and prophylactic IVIg use - real-world use of concomitant and subsequent treatments	—

Measure

Time frame

real-world treatment patterns with belamaf combination therapies (BVd or BPd), including, but not limited to, description of starting dose and frequency of treatment, duration, and changes in treatment. To assess the real-world effectiveness of belamaf combination therapies (BVd or BPd), in terms of real-world overall response rate (rwORR), duration of response (DoR), and real-world progression-free survival (rwPFS). further explorative endpoints: real-world effectiveness of belamaf combination therapies (BVd or BPd), in terms of real-world overall survival (rwOS) and rwPFS2, duration of treatment (DoT), rwORR, DoR, rwPFS, rwOS, and rwPFS2 among the following sub-populations: a. Patients who received real-world treatment with an anti-CD38 treatment (e.g., daratumumab or isatuximab) after real-world treatment with belamaf combination therapies (BVd or BPd) b. Patients who received treatment with an anti-CD38 treatment before treatment with belamaf combination therapies (BVd [stratified by 2L or 3L+] or BPd [stratified by 2L or 3L+]) - incidence, severity, and duration of eye-related side effects (ERSEs) and the management steps executed to mitigate them - incidence and grade of infections and prophylactic IVIg use - real-world use of concomitant and subsequent treatments

—

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026