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Immunomodulatory Agent

CC-92328 for Multiple Myeloma

Phase 1
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be ≥ 18 years of age at the time of signing the ICF.
Participant must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights

Study Summary

This trial is testing a new drug for people with multiple myeloma who have relapsed or are refractory to other treatments. The goal is to see if the drug is safe and tolerable and if it has any preliminary biological or clinical activity.

Who is the study for?
This trial is for adults with relapsed or refractory multiple myeloma who have tried other treatments without success. They must be able to perform daily activities with ease (ECOG PS of 0 or 1), understand the study, and follow its schedule. Women who can become pregnant and men must use effective birth control. People cannot join if they are pregnant, recently had certain vaccines or transplants, weigh under 40 kg, have active hepatitis B/C, HIV, or MM affecting the brain.Check my eligibility
What is being tested?
The trial tests CC-92328's safety and effectiveness in two parts: first by increasing doses to find a safe amount (Part A) and then giving this dose to more people to further assess its effects (Part B). It's aimed at those whose multiple myeloma has returned after treatment or hasn't responded to previous therapies.See study design
What are the potential side effects?
Since CC-92328 is being tested for the first time in humans, potential side effects are not yet fully known but may include typical reactions related to cancer drugs such as nausea, fatigue, blood count changes, risk of infection among others based on similar treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am a male and will either not have sex or will use a condom.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-Limiting Toxicities (DLTs)
Incidence of Adverse Events (AEs)
Maximum Tolerated Dose (MTD)
Secondary outcome measures
Frequency of Anti-CC92328 antibodies (ADA)
Pharmacokinetics - AUC
Pharmacokinetics - Accumulation index of CC-92328
+12 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Administration of CC-92328Experimental Treatment1 Intervention
CC-92328 administered intravenously in 28-day cycles

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
636 Previous Clinical Trials
128,901 Total Patients Enrolled
142 Trials studying Multiple Myeloma
40,793 Patients Enrolled for Multiple Myeloma
Marie Nguyen, MDStudy DirectorCelgene
3 Previous Clinical Trials
321 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,506 Previous Clinical Trials
3,369,460 Total Patients Enrolled
72 Trials studying Multiple Myeloma
25,217 Patients Enrolled for Multiple Myeloma

Media Library

CC-92328 (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04975399 — Phase 1
Multiple Myeloma Research Study Groups: Administration of CC-92328
Multiple Myeloma Clinical Trial 2023: CC-92328 Highlights & Side Effects. Trial Name: NCT04975399 — Phase 1
CC-92328 (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04975399 — Phase 1

Frequently Asked Questions

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

What are the objectives of this scientific experiment?

"The primary objective of this clinical trial, which will be monitored within a 12 week window after the final dose is administered, is to ascertain Maximum Tolerated Dose (MTD). Secondary endpoints being evaluated include Total body clearance of drug from serum (Pharmacokinetics - CL), Overall Survival (Time taken for death due to any cause post first CC-92328 dosage) and Area under Curve analysis."

Answered by AI

Are there a range of medical centers conducting this investigation within city limits?

"This study is being conducted in numerous locations across the world, such as University Of Alabama At Birmingham Hospital in Birmingham, Local Institution - 203 in Halifax, and Local Institution - 205 in Montreal. Altogether 17 sites are participating."

Answered by AI

How risk-free is CC-92328 for individuals?

"Due to the limited data supporting efficacy and safety, CC-92328 was assigned a score of 1 on our team's risk assessment scale."

Answered by AI

What is the capacity for participants in this investigation?

"To conclude this clinical trial, the sponsor Celgene needs to recruit 70 qualified participants from multiple sites such as University Of Alabama At Birmingham Hospital in Birmingham and Local Institution - 203 in Halifax."

Answered by AI

Are there still openings available for this clinical experiment?

"Correct. The details hosted on clinicaltrials.gov demonstrate that this research, which was initially posted on October 5th 2021, is still in need of participants. Seventy individuals are needed to be recruited from 17 physical trial centres."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Safety and Tolerability of CC-92328 in Participants With Relapsed and/or Refractory Multiple Myeloma
2021. "Study to Evaluate the Safety and Tolerability of CC-92328 in Participants With Relapsed and/or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04975399.
~22 spots leftby Jul 2025
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