- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05503550
Pre-Approval Access Single Patient Request for Talquetamab in Relapsed or Refractory Multiple Myeloma
December 8, 2025 updated by: Janssen Research & Development, LLC
Pre-Approval Access Single Patient Request Treatment for Talquetamab for Treating Physician Use in Relapsed or Refractory Multiple Myeloma
The purpose of this pre-approval access program is to provide talquetamab for the treatment of participants with relapsed or refractory multiple myeloma.
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
August 12, 2022
First Submitted That Met QC Criteria
August 12, 2022
First Posted (Actual)
August 16, 2022
Study Record Updates
Last Update Posted (Actual)
December 16, 2025
Last Update Submitted That Met QC Criteria
December 8, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Neoplasms
- Disease Attributes
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Neoplasms, Plasma Cell
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Hemorrhagic Disorders
- Pathological Conditions, Signs and Symptoms
- Hemic and Lymphatic Diseases
- Recurrence
- Multiple Myeloma
- talquetamab
Other Study ID Numbers
- CR109169
- 64407564MMY4002 (Other Identifier: Janssen Research & Development, LLC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Relapsed or Refractory Multiple Myeloma
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Regeneron PharmaceuticalsRecruitingRelapsed and/or Refractory Multiple Myeloma (RRMM)United States, United Kingdom, Australia, South Korea
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BeBetter Med IncCompletedRelapsed or Refractory Multiple Myeloma | Relapsed or Refractory Non-Hodgkin's LymphomaChina
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AmgenTerminatedRelapsed or Refractory Multiple Myeloma | Relapsed or Refractory Acute Myeloid LeukemiaUnited States, Australia, Japan, Germany, Canada
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Institut de Recherches Internationales ServierADIR, a Servier Group companyTerminatedRelapsed or Refractory Multiple Myeloma | Relapsed or Refractory Acute Myeloid Leukemia | Relapsed or Refractory Non-Hodgkin Lymphoma | Relapsed or Refractory Chronic Lymphocytic LeukemiaUnited Kingdom, Spain, France, Australia
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Zhongshan Hospital (Xiamen), Fudan UniversityNot yet recruitingMultiple Myeloma Progression | Multiple Myeloma Refractory
-
Novartis PharmaceuticalsCompletedRefractory Multiple Myeloma | Multiple Myeloma in Relapse | Relapsed and Bortezomib Refractory Multiple MyelomaUnited States
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Oncopeptides ABTerminatedRelapsed Multiple Myeloma | Relapsed-Refractory Multiple MyelomaSerbia, Greece, Russian Federation, Czechia, Bulgaria, Georgia, Norway, Poland, Spain, Ukraine, Germany
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Oncopeptides ABTerminatedRelapsed and/or Relapsed-refractory Multiple MyelomaUnited States, Netherlands, Denmark, Sweden, Italy
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University of LeedsCompletedRelapsed or Refractory Multiple MyelomaUnited Kingdom
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Memorial Sloan Kettering Cancer CenterExelixisCompletedRelapsed or Refractory Multiple MyelomaUnited States
Clinical Trials on Talquetamab
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Memorial Sloan Kettering Cancer CenterJanssen PharmaceuticalsRecruitingMultiple MyelomaUnited States
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First Affiliated Hospital of Chongqing Medical...Not yet recruitingMyasthenia Gravis (MG)
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Janssen-Cilag Ltd.RecruitingRelapsed/Refractory Multiple Myeloma (RRMM)Spain, Sweden, Israel, Germany, Greece, United Kingdom, France, Norway, Italy, Denmark, Ireland
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Noffar BarJohnson & JohnsonRecruiting
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Janssen Research & Development, LLCActive, not recruitingHematological MalignanciesUnited States, Netherlands, Spain, Belgium
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Medical College of WisconsinRecruitingRefractory Multiple Myeloma | Relapse Multiple MyelomaUnited States
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Janssen Research & Development, LLCApproved for marketingRelapsed or Refractory Multiple MyelomaBrazil, Germany, Italy, Netherlands, Romania, Switzerland, United Kingdom
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Larysa SanchezJanssen Research & Development, LLCRecruitingMultiple Myeloma in RelapseUnited States
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Janssen Research & Development, LLCActive, not recruitingMultiple MyelomaUnited States, Israel, Japan, Spain, Canada, Australia, South Korea
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Janssen Research & Development, LLCRecruitingHematological MalignanciesUnited States, Israel, Spain, Japan, Belgium, Netherlands, China, France, Germany, Poland, South Korea