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

First listed

Apr 21, 2022

Start date

May 25, 2022

Status verified

Jul 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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