Long-term Follow-up Study for Participants Previously Treated with Ciltacabtagene Autoleucel

Phase 4

Recruiting

Conditions: Multiple Myeloma

Registration Number: 2023-505530-10-00

Lead Sponsor: Janssen - Cilag International

Brief Summary: To collect long-term follow-up data on delayed adverse events after administration of cilta-cel, and to characterize and understand the long-term safety profile of cilta-cel.

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 55

Inclusion Criteria

All subjects who received cilta-cel in a Company-sponsored clinical study are candidates for Study MMY4002. The inclusion criteria for the study are described below: 1. Subjects who have received at least one dose of cilta-cel in a Company-sponsored clinical study.

Subjects who have provided informed consent for Study MMY4002.

Exclusion Criteria

No exclusion criteria are applicable in this study.

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of subjects with delayed adverse events associated with administration of Cilta-cel. The following adverse events will be collected: - New malignancies and recurrence of preexisting malignancy (all grades)		Number of subjects with delayed adverse events associated with administration of Cilta-cel. The following adverse events will be collected: - New malignancies and recurrence of preexisting malignancy (all grades)
- New incidence or exacerbation of a preexisting neurologic disorder (all grades)		- New incidence or exacerbation of a preexisting neurologic disorder (all grades)
- New incidence or exacerbation of a preexisting rheumatologic or other autoimmune disorder (all grades)		- New incidence or exacerbation of a preexisting rheumatologic or other autoimmune disorder (all grades)
- New incidence of Grade ≥3 hematologic disorder including hypogammaglobulinemia (Years 1-5).Serious hematologic disorder including hypogammaglobulinemia (Years 6-15).		- New incidence of Grade ≥3 hematologic disorder including hypogammaglobulinemia (Years 1-5).Serious hematologic disorder including hypogammaglobulinemia (Years 6-15).
- New incidence of Grade ≥3 infection (Years 1-5).Serious infection(Years 6-15).		- New incidence of Grade ≥3 infection (Years 1-5).Serious infection(Years 6-15).
- All SAEs (Years 1-5). Only related SAEs as assessed by the Investigator (Years 6-15).		- All SAEs (Years 1-5). Only related SAEs as assessed by the Investigator (Years 6-15).

Secondary Outcome Measures

Name	Time	Method
- Number of subjects with measurable RCL in peripheral blood.		- Number of subjects with measurable RCL in peripheral blood.
- Number of subjects with CAR transgene level >lower limit of quantitation (LLOQ) in peripheral blood cells.		- Number of subjects with CAR transgene level >lower limit of quantitation (LLOQ) in peripheral blood cells.
- Assessment of the pattern of lentiviral vector integration sites if at least 1% of cells in the blood sample or new malignancy are positive for vector sequences.		- Assessment of the pattern of lentiviral vector integration sites if at least 1% of cells in the blood sample or new malignancy are positive for vector sequences.
- Long term follow-up on CAR-T therapy efficacy if the subject does not have confirmed disease progression or does not initiate subsequent antimyeloma therapy at the entry of the study and at any time of during the study.		- Long term follow-up on CAR-T therapy efficacy if the subject does not have confirmed disease progression or does not initiate subsequent antimyeloma therapy at the entry of the study and at any time of during the study.
- Overall Survival (OS)		- Overall Survival (OS)

Trial Locations

Locations (9): Centre Hospitalier Universitaire De Lille
🇫🇷
Lille Cedex, France
Assistance Publique Hopitaux De Paris
🇫🇷
Paris, France
Centre Hospitalier Universitaire De Nantes
🇫🇷
Nantes, France
Amsterdam UMC
🇳🇱
Amsterdam, Netherlands
Universitair Medisch Centrum Groningen
🇳🇱
Groningen, Netherlands
UZ Leuven
🇧🇪
Leuven, Belgium
Universitair Ziekenhuis Gent
🇧🇪
Gent, Belgium
Clinica Universidad De Navarra
🇪🇸
Pamplona, Spain
Hospital Universitario De Salamanca
🇪🇸
Salamanca, Spain
Centre Hospitalier Universitaire De Lille
🇫🇷Lille Cedex, France
Ibrahim Yakoub-Agha
Site contact
+330320445551
ibrahim.yakoubagha@chru-lille.fr