Belantamab for Multiple Myeloma

(DREAMM-20 Trial)

Recruiting at 21 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: GlaxoSmithKline

Must not be taking: Antibiotics, Antivirals, Antifungals, others

Disqualifiers: Amyloidosis, POEMS syndrome, Leukemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

55 Participants Needed

Trial Summary

What is the purpose of this trial?

The study consists of two 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 dose ratios of belantamab mafodotin in combination with belantamab (delivered as separate drugs) in participants with RRMM who have received at least 3 prior therapies (4L+).

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

This trial is for individuals with Multiple Myeloma who've had at least three prior treatments, including an immunomodulating agent, a proteasome inhibitor, and an anti-CD38 mAb. They should have no active infections, be in relatively good health (ECOG-PS of 0 to 2), and meet specific laboratory criteria indicating the presence of myeloma.

Inclusion Criteria

My transplant was over 100 days ago.

I do not have any current infections.

I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive escalating doses of single agent belantamab until progressive disease

Until progressive disease

Treatment Part 2

Participants receive belantamab in combination with a fixed dose of belantamab mafodotin until progressive disease

Until progressive disease

Optional Extension

Participants have the option to receive treatment with single agent belantamab mafodotin after progressive disease

Until progressive disease

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Belantamab
• Belantamab Mafodotin
• Dexamethasone
• Lenalidomide
• Standard of Care

Trial Overview The study tests Belantamab as a single agent and in combination with Belantamab mafodotin in patients with refractory Multiple Myeloma. It aims to find safe dosages while assessing the drugs' effectiveness against this type of cancer after several other treatments have failed.

Participant Groups

Group I: Part 2: Belantamab and belantamab mafodotin (delivered as separate drugs) dose range finding Experimental Treatment 1 Intervention

Participants with RRMM will receive belantamab in combination with a fixed dose of belantamab mafodotin (delivered as separate drugs)

Group II: Part 1b: Optional belantamab mafodotin Experimental Treatment 1 Intervention

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.

Group III: Part 1: Dose escalation of belantamab monotherapy Experimental Treatment 1 Intervention

Belantamab will be administered in participants with RRMM until progressive disease (PD)

Belantamab is already approved in United States, European Union for the following indications:

Approved in United States as Blenrep for:

• Relapsed or refractory multiple myeloma in adults

Approved in European Union as Blenrep for:

• Relapsed or refractory multiple myeloma in adults

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School