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Monoclonal Antibodies

Part 1: Dose Escalation for Multiple Myeloma

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

Study 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.Check my eligibility

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).See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

976 Previous Clinical Trials

6,384,522 Total Patients Enrolled

70 Trials studying Multiple Myeloma

19,292 Patients Enrolled for Multiple Myeloma

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

746 Previous Clinical Trials

3,960,108 Total Patients Enrolled

49 Trials studying Multiple Myeloma

14,259 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At present, how many distinct locations are simultaneously conducting this experimental investigation?

"At the moment, enrollment is open at 25 medical sites. Besides Liege, Rennes, and Duarte; various other places are also hosting this trial. Opting for a location in close proximity to you can lessen the burden of travel when engaging in the study."

Answered by AI

How large is the patient cohort involved in this ongoing medical study?

"Indeed, as per clinicaltrials.gov, this trial is presently enrolling subjects. It was initially disclosed on November 22nd, 2022 and recently revised on March 26th, 2024. The research study intends to recruit a total of 170 participants from a network of 25 sites."

Answered by AI

Is this medical trial currently accepting new participants?

"As per clinicaltrials.gov, patient recruitment is currently underway for this investigation. The trial was originally posted on November 22nd, 2022 and most recently revised on March 26th, 2024."

Answered by AI

What are the anticipated results that researchers hope to achieve from conducting this medical study?

"The principal objective of this investigation, to be evaluated over a period extending up to 2 years and 5 months, is the assessment of Adverse Events (AEs) by Severity among participants in Parts 1 and 2. Additional objectives include evaluating the Preliminary Anticancer Activity of JNJ-79635322 according to International Myeloma Working Group (IMWG) criteria from 2016. Moreover, secondary endpoints encompass assessing Time to Response (TTR) as per guidelines outlined in the International Amyloidosis Consensus Criteria and determining Duration of Response (DOR) based on IMWG's response criteria from 201"

Answered by AI

What is the level of safety demonstrated in Part 1: Dose Escalation for individuals?

"Based on our assessment, the safety rating for Part 1: Dose Escalation is graded as 1 due to its Phase 1 nature. This implies that there is a scarcity of data backing both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis

2022. "A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05652335.

All > Al Amyloidosis > Amyloidosis