NCT05972135

Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients

Detailed description

* This is a three-arm, non-randomized, multicenter, prospective study in adult patients with RRMM, who are administered Teclistamab (TECVAYLI™) or Talquetamab (TALVEY™), in the post-marketing setting. * Teclistamab (TECVAYLI™) is a humanized IgG-4 PAA bispecific antibody designed to target the CD3 receptor complex on T cells and BCMA on B-lineage cells. * Talquetamab (TALVEY™) is a humanized IgG-4 bispecific antibody designed to target the CD3 receptor complex on T cells and GPRC5D-expressing multiple myeloma (MM) cells This study will investigate the use of prophylactic tocilizumab or prophylactic dexamethasone to reduce the incidence and severity of CRS associated with teclistamab or talquetamab administration, to enable administration of the step-up dosing regimen of teclistamab or talquetamab in an outpatient setting.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Teclistamab	Teclistamab will be administered subcutaneously at step-up doses on Day 1, Day 4 and Day 8, one week after first treatment dose and weekly thereafter. In participants who have a partial response (PR) or better after 6 months of therapy, dosing frequency may be reduced to every 2 weeks.
DRUG	Talquetamab	Talquetamab will be administered subcutaneously at step-up doses on Day 1, Day 4, Day 8 and Day 15, one week after first treatment dose and every 2 weeks thereafter. In participants who have a very good partial response (VGPR) or better after Cycle 4, dosing frequency may be reduced to every 4 weeks
DRUG	Tocilizumab	Tocilizumab will be administered as a pretreatment medication in advance of administration of the first step-up dose of teclistamab or talquetamab on Cycle 1 Day 1.
DRUG	Oral Dexamethasone	Oral dexamethasone will be administered as a pretreatment medication every 12 hours in 3 doses (PM/AM/PM) following each step-up dose and the first full dose of teclistamab in Cycle 1. A total of 9 doses of oral dexamethasone will be administered.

Timeline

• Start date: 2023-10-23
• Primary completion: 2027-08-01
• Completion: 2027-10-01
• First posted: 2023-08-02
• Last updated: 2026-02-23

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study