JNJ-79635322 for Multiple Myeloma and AL Amyloidosis

Phase 1

Recruiting

Research Sponsored by Janssen Research & Development, 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 2 years 5 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine the safe dosage and schedule for JNJ-79635322 in Part 1 and evaluate its safety and effectiveness in different disease subgroups in Part 2.

Who is the study for?

This trial is for adults with relapsed or refractory multiple myeloma or AL amyloidosis who've had several prior treatments, including a proteasome inhibitor, IMiD agent, and anti-CD38 therapy. They must have measurable disease indicators like specific protein levels in blood/urine or certain types of lesions. Participants need to be fairly active and healthy otherwise (ECOG status 0 or 1) and not suitable for other proven therapies.

What is being tested?

The study tests JNJ-79635322's safety at different doses in people with multiple myeloma or AL amyloidosis who haven't responded well to standard treatments. It has two parts: finding the safest dose (Part 1) and then seeing how well it works at that dose across different patient groups (Part 2).

What are the potential side effects?

While the side effects of JNJ-79635322 are being studied, similar drugs often cause fatigue, nausea, immune system changes leading to increased infection risk, potential organ inflammation, allergic reactions during infusion into the body, and blood-related issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years 5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years 5 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Part 1: Number of Participants with Dose-limiting Toxicity (DLT)

Part 2: Number of Participants with Abnormalities in Laboratory Values

Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity

Secondary study objectives

Duration of Response (DOR) as Defined by IMWG 2016 Response Criteria

Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322

Part 2: Duration of Response (DOR) as Defined by International Amyloidosis Consensus Criteria

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: Dose ExpansionExperimental Treatment1 Intervention

Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1.

Group II: Part 1: Dose EscalationExperimental Treatment1 Intervention

Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified.

Do I qualify?Apply below to find out