Study Comparing Teclistamab Alone to Other Drug Combinations in Patients with Relapsed or Hard-to-Treat Multiple Myeloma

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05572515

Provider View

This clinical trial is comparing the effectiveness of a new drug, teclistamab, to other existing drug combinations in treating patients with multiple myeloma that has returned or is not responding to treatment.

Patient Parameters

Program Overview

The aim of this study is to see if teclistamab, a new type of treatment, is more effective than current drug combinations in helping patients with multiple myeloma, a type of blood cancer, that has come back or is not responding to previous treatments. The study will involve a screening phase, a treatment phase, and a follow-up phase, and will last up to 9 years. Participants will be monitored for safety through physical exams, lab tests, and other assessments.

Description

Multiple myeloma is a type of cancer that affects plasma cells in the blood and is currently incurable. This study is testing a new drug called teclistamab, which is designed to help the body's immune system target and destroy cancer cells. Teclistamab works by bringing certain immune cells closer to the cancer cells, which may help in killing the cancer cells. The study will compare teclistamab to other drug combinations that include pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd). The main goal is to see if teclistamab can help patients live longer without their cancer getting worse compared to the other treatments. Participants will go through a screening process to ensure they meet the study criteria, receive the treatment, and then be followed up to monitor their health and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of multiple myeloma based on specific medical criteria.
  • Have measurable disease at the time of screening.
  • Have received 1 to 3 previous treatments for multiple myeloma, including specific drugs like an anti-CD38 antibody and lenalidomide.
  • Show evidence that the disease is progressing or not responding to the last treatment.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Female participants must agree not to be pregnant or breastfeeding and to use effective contraception during the study and for 6 months after the last treatment.
  • Be willing and able to follow the study's lifestyle guidelines.

Exclusion Criteria

  • Have received any previous treatment targeting BCMA.
  • Not eligible for PVd treatment if they have had prior pomalidomide therapy, cannot be retreated with bortezomib, or have severe allergies or intolerances to these drugs.
  • Not eligible for Kd treatment if they have had prior carfilzomib therapy, have uncontrolled high blood pressure, or have severe nerve damage.
  • Have cancer that has spread to the brain or spinal cord.
  • Have received a live vaccine within 4 weeks before starting the study.
  • Have certain other blood disorders or conditions like plasma cell leukemia or amyloidosis.
  • Have taken high doses of corticosteroids recently.

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