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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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