- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05346835
Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma
December 5, 2023 updated by: Janssen Scientific Affairs, LLC
Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) in Patients With Multiple Myeloma
The purpose of this expanded access program (EAP) is to provide ciltacabtagene autoleucel (cilta-cel) that does not meet the commercial release specifications of CARVYKTI and is not available via the local health care system in the country where the treatment is requested.
Study Overview
Study Type
Expanded Access
Expanded Access Type
- Intermediate-size Population
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Study Contact
- Phone Number: 1-800-526-7736
- Email: Janssenmedinfo@its.jnj.com
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
Description
Inclusion Criteria:
- Eligible for treatment with cilta-cel per United States Prescribing Information (USPI)
- Has serious or life-threatening multiple myeloma per USPI, and where re-apheresis, re-manufacturing, or other anti-myeloma directed therapy is not considered feasible or adequate per treating physician discretion
- Favorable participant benefit/risk assessment determined by Janssen medical review
- Treating physician confirms the favorable risk benefit profile, and that proceeding with this treatment is in the best interest of the participant
- Able to provide informed consent indicating they understand the purpose of this expanded access program (EAP)
- A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test during screening and prior to the first dose of cyclophosphamide and fludarabine
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
March 21, 2022
First Submitted That Met QC Criteria
April 25, 2022
First Posted (Actual)
April 26, 2022
Study Record Updates
Last Update Posted (Actual)
December 6, 2023
Last Update Submitted That Met QC Criteria
December 5, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- CR108968
- 68284528MMY4006 (Other Identifier: Janssen Scientific Affairs, 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 Multiple Myeloma
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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
-
National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
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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
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on Cilta-cel OOS Therapy
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Janssen Research & Development, LLCRecruitingMultiple MyelomaUnited States, Belgium, China, Israel, Netherlands, Spain, Japan
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Peter MacCallum Cancer Centre, AustraliaJanssen, LPRecruiting
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Janssen Scientific Affairs, LLCCompletedMultiple MyelomaUnited States
-
Venus ConceptCompletedSkin DisordersUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteKite, A Gilead CompanyRecruitingLarge B-cell Lymphoma | Relapsed Non-Hodgkin LymphomaUnited States
-
Dana-Farber Cancer InstituteJanssen Research & Development, LLCRecruitingMultiple Myeloma | Smoldering Multiple MyelomaUnited States
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University of NebraskaBristol-Myers SquibbRecruitingFollicular Lymphoma | Refractory Non-Hodgkin Lymphoma | High-grade B-cell Lymphoma | DLBCL - Diffuse Large B Cell Lymphoma | Relapsed Non-Hodgkin Lymphoma | Mediastinal Large B-cell Lymphoma | Indolent B-Cell Non-Hodgkin LymphomaUnited States
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H. Lee Moffitt Cancer Center and Research InstituteIncyte CorporationRecruitingDiffuse Large B Cell LymphomaUnited States
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Janssen Research & Development, LLCActive, not recruitingMultiple MyelomaUnited States, Netherlands, Belgium, Korea, Republic of, United Kingdom, Sweden, Denmark, Italy, Japan, Germany, France, Spain, Australia, Israel, Poland, Greece
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Janssen Research & Development, LLCActive, not recruitingMultiple MyelomaUnited States, Belgium, Germany, Netherlands, Israel, Spain, Saudi Arabia, France