What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as bortezomib and lenalidomide, are associated with several side effects. Bortezomib can cause cytopenias (including thrombocytopenia, neutropenia, and anemia), gastrointestinal distress, and peripheral neuropathy. Lenalidomide is often linked to neutropenia, thrombocytopenia, and diarrhea. Both drugs can lead to fatigue and increased risk of infections. These side effects are important considerations when evaluating treatment options for Multiple Myeloma.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Multiple Myeloma, particularly for relapsed and/or refractory cases. Notable approvals include bortezomib, a proteasome inhibitor, and lenalidomide, an immunomodulatory drug, both of which are often used in combination with dexamethasone. Other significant approvals include carfilzomib, another proteasome inhibitor, and daratumumab, a monoclonal antibody targeting CD38. These drugs have been evaluated in various combinations and regimens to improve efficacy and manage adverse effects. The investigational drug CC-92328, while its mechanism is not specified, is being studied in a similar context of relapsed and/or refractory Multiple Myeloma, suggesting it may share therapeutic goals with these established treatments.

What other types of research exist?

Promising novel alternatives to CC-92328 for Multiple Myeloma patients include: 1) Bortezomib-based regimens, such as bortezomib combined with cyclophosphamide and dexamethasone (CyBorD), which have shown rapid responses and are well-tolerated with once-weekly administration. 2) Immunomodulatory derivatives like lenalidomide, pomalidomide, and thalidomide, which have demonstrated efficacy in relapsed/refractory Multiple Myeloma. 3) Newer agents like CAR T-cell therapies and bispecific antibodies, which are being actively investigated and have shown promising results in clinical trials.

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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 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

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 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: Administration of CC-92328Experimental Treatment1 Intervention

CC-92328 administered intravenously in 28-day cycles

0 / 9Eligibility criteria met

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.