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A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma

NCT05347485 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-04-25

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS).

Conditions

Interventions

DRUG

Cilta-cel

Cilta-cel will be administered as an IV infusion.

DRUG

Lymphodepleting Therapy (Cyclophosphamide and Fludarabine)

Lymphodepleting therapy (cyclophosphamide and fludarabine) will be administered intravenously.

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Scientific Affairs, LLC Clinical Trial · Janssen Scientific Affairs, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-13
Primary Completion
2023-11-30
Completion
2023-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05347485 on ClinicalTrials.gov