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A Study to Investigate Safety and Clinical Activity of Belantamab Mafodotin in Combination With Lenalidomide, Dexamethasone and Nirogacestat in Patients With Transplant Ineligible Newly Diagnosed Multiple Myeloma

NCT05573802 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-10-24

No results posted yet for this study

Summary

This is a phase 1/2, open-label study designed to assess the safety and clinical activity of different belantamab mafodotin doses in combination with lenalidomide, dexamethasone and nirogacestat in patients with transplant ineligible newly diagnosed multiple myeloma.

This will be a 2-part study. In part 1 participants will be enrolled in one cohort to receive belantamab mafodotin in combination with lenalidomide, dexamethasone and nirogacestat and will determine the recommended phase 2 dose (RP2D) to be further evaluated for safety and clinical activity in the dose expansion cohort. The RP2D dose will be used in future studies in the transplant-ineligible newly diagnosed multiple myeloma (NDMM) setting. In the dose expansion phase (Part 2) an expansion cohort will be treated with the RP2D. The expansion cohort will randomize participants (1:1) in two groups to evaluate two alternate dose modification guidelines for corneal AEs. Part 2 of the study will also evaluate an alternative dose modification guideline for corneal adverse events (AEs).

Overall, approximately 36 participants will be enrolled in the study. Participant follow-up will continue up to 3 years after the last participant is enrolled (follow-up period range: 3-4 years). The estimated accrual period will be 12 months, corresponding to an approximate total study duration of 4 years.

Conditions

  • Multiple Myeloma
  • Neoplasms
  • Neoplasm, Plasma Cell
  • Gammopathy, Monoclonal
  • Paraproteinemias
  • Blood Protein Disorders
  • Haematologic Disease
  • Corneal Disease

Interventions

DRUG

Belantamab Mafodotin-Blmf

Blmf will be available as 100 mg/vial in single-use vial for reconstitution, supplied as lyophilized powder. Blmf will be delivered as IV solution over at least 30 minutes.

DRUG

Lenalidomide

Lenalidomide will be administered per os.

DRUG

Dexamethasone

Dexamethasone will be administered intravenously or per os.

DRUG

Nirogacestat

Nirogacestat will be administrated each day for all subsequent cycles were Blmf is also administrated.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Hellenic Society of Hematology

    lead OTHER

Principal Investigators

  • Evangelos Terpos, Prof · Department of Clinical Therapeutics, School of Medicine, National Kapodistrian University of Athens (NKUA)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-14
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Greece

Study Locations

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Drugs
Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05573802 on ClinicalTrials.gov