NCT05493618

Pembrolizumab, Belantamab and Dexamethasone in Refractory Multiple Myeloma.

A Phase II Study of Pembrolizumab, Belantamab and Dexamethasone in Patients With Triple Class Refractory Multiple Myeloma.

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hackensack Meridian Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, multi-institution (1) Hackensack Meridian Health at Hackensack, New Jersey (NJ) (2) Jersey Shore Medical Center, Neptune, NJ and (3) Georgetown/Lombardi Cancer Center) phase II study of the combination of pembrolizumab, belantamab, and dexamethasone in patients with triple class refractory multiple myeloma.

Detailed description

This is a single arm, multi-institution (1) Hackensack Meridian Health at Hackensack, NJ (2) Jersey Shore Medical Center, Neptune, NJ and (3) Georgetown/Lombardi Cancer Center) phase II study of the combination of pembrolizumab, belantamab, and dexamethasone in patients with triple class refractory multiple myeloma. All institutions will share the same Institutional Review Board. Safety lead-in Cohort: After the first 10 patients are enrolled, an independent safety review committee will meet to review adverse events and toxicity and determine whether the trial will continue to enroll. Phase 2 portion: The remainder of patients will be enrolled using a Simon's - 2 stage design. The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

Conditions

• Multiple Myeloma, Refractory

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab 200 mg IV q3 weeks until unacceptable toxicity or disease progression for up to 2 years (35 cycles).
DRUG	Belantamab mafodotin	Belantamab 2.5 mg/kg IV q3 weeks until unacceptable toxicity or disease progression for up to 2 years (35 cycles).
DRUG	Dexamethasone	Dexamethasone 40 mg IV q3 weeks (20 mg if patient \>75) until unacceptable toxicity or disease progression for up to 2 years (35 cycles).

Timeline

• Start date: 2022-12-01
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2022-08-09
• Last updated: 2023-01-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study