Cilta-cel for Multiple Myeloma

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Multiple MyelomaCilta-cel - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will follow patients who have received cilta-cel to see if there are any delayed adverse events.

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

7 Primary · 6 Secondary · Reporting Duration: Up to 15 years

Up to 15 years
Investigator's Response Assessment of Long Term Follow-up on Chimeric Antigen Receptor T-cell (CAR-T) Therapy Based on Local Lab Assessments
Number of Participants with Chimeric Antigen Receptor (CAR) Transgene Level Greater Than (>) Lower Limit of Quantitation (LLOQ) in Peripheral Blood Cells
Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood
Number of Participants with New Incidence of Grade >= 3 Infection
Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder
Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia
Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder
Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder
Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy
Number of Participants with Serious Adverse Events (SAEs)
Overall Survival (OS)
Pattern of Lentiviral Vector Integration Sites
Pattern of Vector Integration Sites

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

Cilta-cel
1 of 1

Experimental Treatment

228 Total Participants · 1 Treatment Group

Primary Treatment: Cilta-cel · No Placebo Group · Phase 4

Cilta-cel
Drug
Experimental Group · 1 Intervention: Cilta-cel · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 years

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
927 Previous Clinical Trials
6,346,981 Total Patients Enrolled
65 Trials studying Multiple Myeloma
17,372 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
713 Previous Clinical Trials
3,919,966 Total Patients Enrolled
47 Trials studying Multiple Myeloma
12,466 Patients Enrolled for Multiple Myeloma

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
California100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of California, San Francisco100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%