A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT06425991
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
108 participants
INTERVENTIONAL
2024-06-07
2027-03-03
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Pre-change Teclistamab
Participants will receive teclistamab monotherapy (made from the pre-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first.
Teclistamab
Teclistamab will be administered subcutaneously.
Arm B: Post-change Teclistamab
Participants will receive teclistamab monotherapy (made from the post-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first.
Teclistamab
Teclistamab will be administered subcutaneously.
Interventions
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Teclistamab
Teclistamab will be administered subcutaneously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Cleveland Clinic Florida
Weston, Florida, United States
Augusta University- Georgia Cancer Center
Augusta, Georgia, United States
St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Franciscan Health
Indianapolis, Indiana, United States
Cleveland Clinic
Cleveland, Ohio, United States
Baylor University Medical Center
Dallas, Texas, United States
Flinders Medical Centre
Bedford Park, , Australia
Box Hill Hospital
Box Hill, , Australia
Royal Prince Alfred Hospital
Camperdown, , Australia
Epworth Healthcare
Richmond, , Australia
Cross Cancer Institute
Edmonton, Alberta, Canada
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, Canada
CHRU de Lille Hopital Claude Huriez
Lille, , France
CHU Nantes
Nantes, , France
CHU de Bordeaux - Hospital Haut-Leveque
Pessac, , France
CHU Lyon Sud
Pierre-Bénite, , France
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Universitatsklinikum Wurzburg
Würzburg, , Germany
Carmel Medical Center
Haifa, , Israel
Hadassah University Hospita Ein Kerem
Jerusalem, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Ospedali Riuniti Di Ancona
Ancona, , Italy
ASST Papa Giovanni XXIII Bergamo
Bergamo, , Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, , Italy
Ospedale Santa Chiara AO Universitaria Pisana
Pisa, , Italy
Policlinico Universitario Agostino Gemelli
Rome, , Italy
Wojewodzki Szpital Specjalistyczny
Biała Podlaska, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Pratia Onkologia Katowice
Katowice, , Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, , Poland
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin, , Poland
Dolnoslaskie Centrum Onkologii
Wroclaw, , Poland
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, , South Korea
Hosp Clinic de Barcelona
Barcelona, , Spain
ICO L'Hospitalet - Hospital Duran i Reynals
Barcelona, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Clinica Univ. de Navarra
Pamplona, , Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, , Spain
Hosp Clinico Univ de Salamanca
Salamanca, , Spain
Hosp. Univ. Marques de Valdecilla
Santander, , Spain
Hammersmith Hospital
London, , United Kingdom
The Christie NHS Foundation Trust Christie Hospital
Manchester, , United Kingdom
Norfolk & Norwich University Hospital
Norwich, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Countries
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Other Identifiers
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64007957MMY1008
Identifier Type: OTHER
Identifier Source: secondary_id
2023-508426-10-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
64007957MMY1008
Identifier Type: -
Identifier Source: org_study_id