Back to resultsTeclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients
Primary Purpose
Relapsed or Refractory Multiple Myeloma
Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Teclistamab
Sponsored by
About this trial
This is an expanded access trial for Relapsed or Refractory Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- Patient diagnosed with Relapsed or Refractory Multiple Myeloma
- Patient exhausted all commercially approved and clinically appropriate (not patient or physician preference) treatment options, and is ineligible for a clinical trial
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT05463939
First Posted
July 1, 2022
Last Updated
November 9, 2022
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05463939
Brief Title
Teclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients
Official Title
Teclistamab US Expanded Access Treatment Protocol for Patients With Relapsed or Refractory Multiple Myeloma
Study Type
Expanded Access
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
5. Study Description
Brief Summary
The purpose of this expanded access treatment protocol is to provide patients access to teclistamab prior to market authorization. The program is limited to patients with relapsed or refractory multiple myeloma who have exhausted all treatment options available as local standard of care and who are not eligible for a teclistamab clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Multiple Myeloma
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Teclistamab
Other Intervention Name(s)
JNJ-64007957
Intervention Description
Teclistamab will be administered subcutaneously (SC).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Patient diagnosed with Relapsed or Refractory Multiple Myeloma
Patient exhausted all commercially approved and clinically appropriate (not patient or physician preference) treatment options, and is ineligible for a clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Teclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients
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