Cilta-cel for Multiple Myeloma

Phase 2

Waitlist Available

Research Sponsored by Janssen Scientific Affairs, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special cancer treatment called cilta-cel that uses modified immune cells. These cells don't meet the usual standards but are still being checked for effectiveness and safety. The treatment aims to help patients whose cancers are hard to treat with regular methods by boosting their own immune system to fight the disease. This type of treatment has shown promising results in treating various blood cancers by modifying patients' immune cells to target cancer.

Eligible Conditions

Multiple Myeloma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate (ORR)

Secondary study objectives

Clinical Benefit Rate (CBR)

Complete Response (CR) Rate

Duration of Response (DOR)

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ciltacabtagene Autoleucel (Cilta-cel)Experimental Treatment2 Interventions

Eligible participants will receive bridging therapy (that is, anti-plasma cell directed treatment) based on participant's clinical status and timing of availability of cilta-cel (JNJ-68284528) along with lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] and fludarabine 30 mg/m\^2 IV daily, for 3 days). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants will receive a single IV infusion of cilta-cel (JNJ-68284528) at a total targeted dose of 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (cells/kg).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cilta-cel

2022

Completed Phase 2

~90

Lymphodepleting Therapy (Cyclophosphamide and Fludarabine)

2022

Completed Phase 2

~90