A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Belantamab — DRUG
  Belantamab will be administered.
• Belantamab mafodotin — DRUG
  Belantamab mafodotin will be administered.
• Pomalidomide — DRUG
  Pomalidomide will be administered.
• Dexamethasone — DRUG
  Dexamethasone will be administered.

Study Details

The study consists of three parts: * Part 1: The primary purpose of this part aims to evaluate the safety, tolerability, and clinical activity of escalating doses of single agent belantamab in participants with refractory multiple myeloma (RRMM) who have received at least 3 prior therapies (4L+). * Part 2: The primary purpose of this part is to evaluate the safety, tolerability, and clinical activity of different doses of belantamab in combination with a fixed dose of Belantamab mafodotin (delivered as separate drugs) in participants with RRMM who have received at least 3 prior therapies (4L+). * Part 3: The Primary purpose of this part will evaluate the clinical activity of a selected dose of the belantamab in combination with the pomalidomide-dexamethasone (Pd) standard of care (SoC) backbone. The study will focus on participants with multiple myeloma who have undergone at least one prior line of therapy, including treatment with lenalidomide.

Key Dates

First listed

Feb 6, 2023

Start date

Jun 14, 2023

Status verified

Aug 2026

Primary completion

Aug 3, 2028

Completion

Aug 3, 2028

Study Design

Enrollment

123 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Dose escalation and expansion of belantamab monotherapy
  Belantamab will be administered in participants with RRMM until progressive disease (PD)
• Experimental: Part 2: Belantamab and belantamab mafodotin (delivered as separate drugs) dose range finding
  Participants with RRMM will receive belantamab and belantamab mafodotin
• Experimental: Part 3: Belantamab +pomalidomide/dexamethasone in 2L+ RRMM
  Participants with RRMM will receive belantamab in combination with pomalidomide-dexamethasone backbone.
• Experimental: Part 1b: Optional belantamab mafodotin
  Participants enrolled in Part 1 and Part 2 will be dosed until PD after which they will have the option to receive treatment with single agent belantamab mafodotin.

Primary Outcome Measure

Parts 1, 2 and 3: Number of Participants with any Adverse Event [ Time Frame: Up to 52 months ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (11)

Find similar trials in Bullhead City, AZ

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