A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma

Conditions

• Relapsed/ Refractory Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Talquetamab — DRUG
  Talquetamab will be administered as a subcutaneous (SC) injection.
• Teclistamab — DRUG
  Teclistamab will be administered as a SC injection.
• PD-1 Inhibitor — DRUG
  The PD-1 inhibitor will be administered as an intravenous injection.

Study Details

The purpose of the study is to identify the safe dose(s) of a PD-1 inhibitor in combination with talquetamab or teclistamab, and to characterize the safety and tolerability of talquetamab or teclistamab when administered in combination with a PD-1 inhibitor.

Key Dates

Start date

May 25, 2022

Status verified

Jun 2026

Primary completion

May 22, 2025

Completion

May 3, 2027

Study Design

Enrollment

74 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Dose Escalation
  Participants will receive either talquetamab (treatment regimen A) or teclistamab (treatment regimen B) with a PD-1 inhibitor biweekly.
• Experimental: Part 2: Dose Expansion
  Participants will receive either treatment regimen A or treatment regimen B with a PD-1 inhibitor at the dose levels identified in Part 1.

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 2 years 5 months ]

Locations (7)

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