?A study to investigate the safety and clinical activity of belantamab for the treatment of multiple myeloma when used as monotherapy and in combination treatments.

?A Phase 1/2 open-label, multicentre, dose escalation and expansion study to investigate the safety, tolerability, and clinical activity of belantamab as monotherapy and in combination with other treatments in participants with multiple myeloma.?

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202606758025670

Enrollment

Registered

2026-06-19

Start date

2026-06-05

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Cancer

Interventions

Belantamab

Belantamab mafodotin

Pomalidomide

Dexamethasone

Belamantab mafodotin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ??Men and women are included in the study if they: 1. ?Are aged = 18 years and have a confirmed MM diagnosis with measurable disease as described in the protocol. 2. ?Have received at least 3 prior lines of anti-myeloma treatments (Part 1 and Part 2) at least 1 prior line of anti-myeloma treatment including leanalidomide (Part3).?

Exclusion criteria

Exclusion criteria: Participants can be excluded from the study if they have: 1. ??Disease of the outermost layer of the eye (cornea). 2. ?Signs and symptoms showing MM affecting the brain and spinal cord. 3. ?Use of any anti-myeloma therapy within 14 days of the study start. ?

Design outcomes

Primary

Measure	Time frame
Part 1: To assess the safety, tolerability and clinical activity (ability to fight cancer) of belantamab monotherapy, given intravenously (IV) to relapsed or refractory MM (RRMM) participants who have had at least three prior therapies Part 2: To assess the safety, tolerability, and clinical activity (ability to fight cancer) of belantamab mafodotin in combination with belantamab (Bb) in participants with RRMM who have had at least three prior therapies. Part 3: To assess the safety, tolerability and clinical activity (ability to fight cancer) of belantamab antibody without (bPd) or with belantamab mafodotin (BbPd) in combination with pomalidomide/dexamethasone in participants with RRMM in participants with RRMM who have received at least 1 prior therapy, including lenalidomide	—

Measure

Time frame

Part 1: To assess the safety, tolerability and clinical activity (ability to fight cancer) of belantamab monotherapy, given intravenously (IV) to relapsed or refractory MM (RRMM) participants who have had at least three prior therapies Part 2: To assess the safety, tolerability, and clinical activity (ability to fight cancer) of belantamab mafodotin in combination with belantamab (Bb) in participants with RRMM who have had at least three prior therapies. Part 3: To assess the safety, tolerability and clinical activity (ability to fight cancer) of belantamab antibody without (bPd) or with belantamab mafodotin (BbPd) in combination with pomalidomide/dexamethasone in participants with RRMM in participants with RRMM who have received at least 1 prior therapy, including lenalidomide

—

Secondary

Measure	Time frame
Part 1: To assess the pharmacokinetic (PK) profile of single and repeat IV dose of belantamab, antidrug antibodies (ADAs) against belantamab and clinical activity of repeat doses of belantamab in RRMM participants. Part 2: To assess how well belantamab and belantamab mafodotin work in treating RRMM by measuring how long responses last, and to evaluate their pharmacokinetic profiles and any anti-drug antibodies that develop Part 3: To further assess how well each treatment works in participants with RRMM, understand how the body handles total belantamab, belantamab mafodotin, and cys-mcMMAF after single or repeat IV doses, and check for any ADAs to these medicines.	—

Measure

Time frame

Part 1: To assess the pharmacokinetic (PK) profile of single and repeat IV dose of belantamab, antidrug antibodies (ADAs) against belantamab and clinical activity of repeat doses of belantamab in RRMM participants. Part 2: To assess how well belantamab and belantamab mafodotin work in treating RRMM by measuring how long responses last, and to evaluate their pharmacokinetic profiles and any anti-drug antibodies that develop Part 3: To further assess how well each treatment works in participants with RRMM, understand how the body handles total belantamab, belantamab mafodotin, and cys-mcMMAF after single or repeat IV doses, and check for any ADAs to these medicines.

—

Countries

South Africa

Contacts

Public ContactItumeleng Siweya

Clinical Operations Director. GMASE Head Clinical Operations South Africa

itumeleng.i.siweya@gsk.com+27103001000

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026