- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05164250
Compassionate Use (CU) of REGN5458 for Patients With Relapsed or Refractory Multiple Myeloma (MM)
November 6, 2025 updated by: Regeneron Pharmaceuticals
Provide Compassionate Use' of REGN5458 for Patients with Relapsed or Refractory Multiple Myeloma
Study Overview
Detailed Description
Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications.
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Description
Inclusion Criteria:
-
Exclusion Criteria:
-
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.
Sponsor
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
December 9, 2021
First Submitted That Met QC Criteria
December 9, 2021
First Posted (Actual)
December 20, 2021
Study Record Updates
Last Update Posted (Estimated)
November 10, 2025
Last Update Submitted That Met QC Criteria
November 6, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Keywords
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
Other Study ID Numbers
- R5458-MM
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 Multiple Myeloma
-
Zhongshan Hospital (Xiamen), Fudan UniversityNot yet recruitingMultiple Myeloma Progression | Multiple Myeloma Refractory
-
University Health Network, TorontoNot yet recruitingMultiple Myeloma in Relapse | Multiple Myeloma RefractoryCanada
-
Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
-
Second Affiliated Hospital, School of Medicine,...Tongji Hospital; Jinhua Municipal Central Hospital; Taizhou Hospital of Zhejiang...RecruitingRelapse Multiple MyelomaChina
-
Guangzhou Bio-gene Technology Co., LtdWithdrawnMultiple Myeloma Refractory
-
Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on REGN5458
-
Regeneron PharmaceuticalsRecruitingRelapsed Refractory Multiple Myeloma (RRMM)Australia
-
Regeneron PharmaceuticalsNot yet recruitingRelapsed/Refractory Multiple Myeloma (RRMM)
-
Regeneron PharmaceuticalsRecruitingRelapsed/Refractory Multiple MyelomaAustralia, United Kingdom
-
Regeneron PharmaceuticalsRecruitingRelapsed/Refractory Systemic Light Chain AmyloidosisUnited States, Spain, United Kingdom, South Korea, Greece
-
Regeneron PharmaceuticalsRecruitingMonoclonal Gammopathy of Undetermined Significance (MGUS) | Smoldering Multiple Myeloma (SMM)United States, Spain, Ireland, Italy, Poland, Belgium, France
-
Regeneron PharmaceuticalsRecruiting
-
Regeneron PharmaceuticalsRecruitingMultiple MyelomaUnited States, Spain, Belgium, Japan, Germany, United Kingdom, South Korea
-
Regeneron PharmaceuticalsActive, not recruiting
-
Regeneron PharmaceuticalsNot yet recruitingHigh Risk Smoldering Multiple Myeloma (HR-SMM)
-
Regeneron PharmaceuticalsRecruiting