Trials
Search / Trial NCT06425991

A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · May 17, 2024

Trial Information

Current as of February 19, 2025

Recruiting

Keywords

1 3 Prior Lines

ClinConnect Summary

This clinical trial is looking to compare two different versions of a medication called teclistamab for patients with relapsed or refractory multiple myeloma, which is a type of blood cancer that has returned or did not respond to previous treatments. The study aims to understand how the body processes this drug, focusing on two manufacturing methods: the current one and a new one.

To be eligible for this trial, participants need to have a confirmed diagnosis of multiple myeloma and must have already received at least one to three treatments for their cancer. They should also show signs that their disease is not responding to the last treatment. The trial is open to adults aged 65 and older, and both men and women can participate. Participants will receive either of the two versions of teclistamab and will be monitored for their health and any side effects. It's important to note that individuals with certain health conditions or recent surgeries may not qualify for this study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Documented diagnosis of multiple myeloma as defined by the criteria below: (a) Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level \>=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain \>=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio
  • Received 1 to 3 prior lines of antimyeloma therapy, including a minimum of 2 consecutive cycles each of a protease inhibitor (PI), lenalidomide, and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (or minimum of 6 doses if anti CD38 monoclonal antibody was only part of a maintenance regimen) in any prior line
  • Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by IMWG criteria
  • Have an eastern cooperative oncology group (ECOG) performance status score of 0 to 2
  • A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study
  • Exclusion Criteria:
  • Received any bispecific antibody and/or chimeric antigen receptor T cell (CAR-T) cell therapy
  • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
  • Received a live, attenuated vaccine within 4 weeks before the first dose of study drug. Non-live or non-replicating vaccines authorized for emergency use by local health authorities are allowed
  • Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology may be required
  • Participant had major surgery or had significant traumatic injury within 2 weeks prior to randomization, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study

Trial Officials

Janssen Research & Development, LLC Clinical Trial

Study Director

Janssen Research & Development, LLC

About Janssen Research & Development, Llc

Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing innovative therapies in multiple therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. With a strong commitment to scientific excellence and patient-centered research, Janssen leverages cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. The company is focused on addressing unmet medical needs through rigorous clinical trials and a robust pipeline, aiming to improve health outcomes and enhance the quality of life for patients worldwide.

Locations

Edmonton, Alberta, Canada

Dallas, Texas, United States

Cleveland, Ohio, United States

Weston, Florida, United States

Tel Aviv, , Israel

Denver, Colorado, United States

Plymouth, , United Kingdom

London, , United Kingdom

Heidelberg, , Germany

Chemnitz, , Germany

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Camperdown, , Australia

Norwich, , United Kingdom

Pisa, , Italy

Gdansk, , Poland

Meldola, , Italy

Brescia, , Italy

Bedford Park, , Australia

Lublin, , Poland

Lille, , France

Gilbert, Arizona, United States

Rome, , Italy

Wroclaw, , Poland

Würzburg, , Germany

Ancona, , Italy

Haifa, , Israel

Madrid, , Spain

Santander, , Spain

Box Hill, , Australia

Katowice, , Poland

Seoul, , Korea, Republic Of

Barcelona, , Spain

Pamplona, , Spain

Ramat Gan, , Israel

Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of

Pozuelo De Alarcon, , Spain

Nantes Cedex 1, , France

Kielce, , Poland

Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of

Richmond, , Australia

Toronto, Ontario, Canada

Pessac Cedex, , France

Manchester, , United Kingdom

Bergamo, , Italy

Pierre Benite, , France

Biala Podlaska, , Poland

Seoul, , Korea, Republic Of

Barcelona, , Spain

Salamanca, , Spain

Jerusalem, , Israel

Augusta, Georgia, United States

Katowice, , Poland

Hamburg, , Germany

Indianapolis, Indiana, United States

Gdansk, , Poland

Kielce, , Poland

Lublin, , Poland

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0