Brief Summary
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.
Brief Title
Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
1-800-526-7736
Central Contact Email
Janssenmedinfo@its.jnj.com
Conditions
Multiple Myeloma
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05346835
Org Class
Industry
Org Full Name
Janssen Scientific Affairs, LLC
Org Study Id
CR108968
Overall Status
Available
Official Title
Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) in Patients With Multiple Myeloma
Secondary Ids
Secondary Id
68284528MMY4006
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Nishi Shah
Investigator Email
nisshah@montefiore.org
Categories Mesh Debug
Blood & Bone Marrow Cancers --- MULTIPLE MYELOMA
Blood & Bone Marrow Cancers --- NEOPLASMS, PLASMA CELL
Blood & Bone Marrow Cancers --- NEOPLASMS BY HISTOLOGIC TYPE
Cancer --- NEOPLASMS
Endocrine System Cancers --- NEOPLASMS
Gastrointestinal (GI) Cancers --- NEOPLASMS
Gynecologic Cancers --- NEOPLASMS
Lung & Chest Cancers --- NEOPLASMS
Prostate Cancer --- NEOPLASMS
Blood & Bone Marrow Cancers --- HEMOSTATIC DISORDERS
Blood & Bone Marrow Cancers --- VASCULAR DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- PARAPROTEINEMIAS
Blood & Bone Marrow Cancers --- BLOOD PROTEIN DISORDERS
Blood Disorders --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- HEMORRHAGIC DISORDERS
Blood & Bone Marrow Cancers --- LYMPHOPROLIFERATIVE DISORDERS
Blood & Bone Marrow Cancers --- IMMUNOPROLIFERATIVE DISORDERS
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
MeSH Terms
MULTIPLE MYELOMA
NEOPLASMS, PLASMA CELL
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
HEMOSTATIC DISORDERS
VASCULAR DISEASES
CARDIOVASCULAR DISEASES
PARAPROTEINEMIAS
BLOOD PROTEIN DISORDERS
HEMATOLOGIC DISEASES
HEMIC AND LYMPHATIC DISEASES
HEMORRHAGIC DISORDERS
LYMPHOPROLIFERATIVE DISORDERS
IMMUNOPROLIFERATIVE DISORDERS
IMMUNE SYSTEM DISEASES