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Pre-approval Access Single Patient Request for Teclistamab (JNJ-64007957)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05161598
Expanded Access Status : No longer available
First Posted : December 17, 2021
Last Update Posted : June 27, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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Brief Summary:
Teclistamab pre-approval access in relapsed or refractory multiple myeloma.

Condition or disease Intervention/treatment
Multiple Myeloma Drug: Teclistamab

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: PRE-APPROVAL ACCESS (PAA) Single Patient Request (SPR) TREATMENT GUIDELINES for Teclistamab (JNJ-64007957) for Treating Physician Use

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Interventions
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Intervention Details:
  • Drug: Teclistamab
    Teclistamab will be administered subcutaneously (SC).
    Other Name: JNJ-64007957
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria
Must have relapsed/refractory multiple myeloma (RRMM) and have evidence of disease progression after last therapy. Must have exhausted all available treatment options accessible as local standard of care (example. proteasome inhibitors [PIs], immunomodulatory imide drugs [IMIDs], anti CD38 monoclonal antibodies [mAbs] and therapies targeting Exportin 1 [XPO1] and B cell maturation antigen [BCMA]). Must not be eligible for a clinical trial with teclistamab or other medicines in this setting
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05161598


Locations
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Denmark
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Estonia
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Iceland
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Ireland
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Israel
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Italy
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Lithuania
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Portugal
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Romania
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Switzerland
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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT05161598    
Other Study ID Numbers: CR108846
64007957PTL4001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: December 17, 2021    Key Record Dates
Last Update Posted: June 27, 2022
Last Verified: June 2022
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases