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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.
Must not have
Participant had a prior autologous stem cell transplant ≤ 90 days prior to starting CC-92328.
Participant weight is ≤ 40 kg at screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called CC-92328 to see if it is safe and effective for patients with multiple myeloma that has come back or didn't respond to other treatments. The study will see if the drug can slow down or stop the cancer.
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had a stem cell transplant using my own cells less than 3 months ago.
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I weigh 40 kg or less.
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I have an active HIV infection.
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My multiple myeloma has spread to my brain and is causing symptoms.
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I have an active hepatitis B or C infection.
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I had a stem cell transplant less than a year ago before starting treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose-Limiting Toxicities (DLTs)
Incidence of Adverse Events (AEs)
Maximum Tolerated Dose (MTD)
Secondary study objectives
Frequency of Anti-CC92328 antibodies (ADA)
Pharmacokinetics - AUC
Pharmacokinetics - Accumulation index of CC-92328
+12 moreAwards & 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: Administration of CC-92328Experimental Treatment1 Intervention
CC-92328 administered intravenously in 28-day cycles
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Multiple Myeloma treatments often include proteasome inhibitors (e.g., bortezomib, carfilzomib), which block the proteasome's ability to degrade proteins, leading to cancer cell death. Immunomodulatory drugs (e.g., lenalidomide, pomalidomide) enhance the immune system's response against myeloma cells and inhibit their growth.
Monoclonal antibodies (e.g., daratumumab, isatuximab) target specific proteins on myeloma cells, marking them for destruction by the immune system. These mechanisms are crucial as they directly target the cancer cells' survival pathways, improving patient outcomes by reducing tumor burden and prolonging remission periods.
Monoclonal antibodies for the treatment of cancer.
Monoclonal antibodies for the treatment of cancer.
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Who is running the clinical trial?
CelgeneLead Sponsor
645 Previous Clinical Trials
130,113 Total Patients Enrolled
146 Trials studying Multiple Myeloma
41,736 Patients Enrolled for Multiple Myeloma
Marie Nguyen, MDStudy DirectorCelgene
4 Previous Clinical Trials
576 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,579 Previous Clinical Trials
3,387,550 Total Patients Enrolled
77 Trials studying Multiple Myeloma
29,049 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must have a disease that can be measured.I am 18 years old or older.I had a stem cell transplant using my own cells less than 3 months ago.My multiple myeloma has returned or didn't respond to treatment, and I can't use or have failed all other treatments.I weigh 40 kg or less.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had cancer treatments or experimental drugs within the last 4 weeks or 5 half-lives, whichever is shorter.I agree not to conceive or father a child during the study and for 12 weeks after.I am committed to not having heterosexual contact or using effective birth control during and for 12 weeks after my treatment.I have an active HIV infection.My myeloma worsened within 12 months after my last treatment.My multiple myeloma has spread to my brain and is causing symptoms.I have an active hepatitis B or C infection.I have not received any live virus vaccines in the last 4 weeks.I am a male and will either not have sex or will use a condom.I had a stem cell transplant less than a year ago before starting treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Administration of CC-92328
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.