What side effects are associated with this type of intervention?

Common treatments for amyloidosis include daratumumab, bortezomib, cyclophosphamide, and dexamethasone. Known side effects of these treatments can include cytopenias (low blood cell counts), peripheral neuropathy, gastrointestinal issues, fatigue, infections, and fluid retention. Specifically, bortezomib is associated with peripheral sensory neuropathy and gastrointestinal disorders, while daratumumab can cause infusion-related reactions. Cyclophosphamide may lead to cytopenias and increased risk of infections. Dexamethasone can cause fluid retention, hyperglycemia, and mood changes. These side effects are important to consider when evaluating treatment options with a healthcare provider.

What prior FDA approvals exist?

For the treatment of AL amyloidosis, several drugs have been utilized, including lenalidomide, cyclophosphamide, dexamethasone, and pomalidomide-based regimens. These treatments have shown varying degrees of efficacy and acceptable toxicity profiles. While the context does not specify FDA-approved BCL-2 inhibitors for Amyloidosis, it highlights the ongoing exploration of novel agents like APG-2575 in clinical trials for related hematologic malignancies.

What other types of research exist?

Tolcapone is a promising novel alternative for amyloidosis patients, as it has shown potent inhibition of transthyretin amyloidogenesis and associated cellular toxicity. It is already in clinical trials for familial amyloid polyneuropathy and could be a strong candidate for therapeutic intervention in amyloidosis.

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Small Molecule

APG-2575 Combinations for Multiple Myeloma

Phase 1 & 2

Recruiting

Led By Wensi Li, M. M, MD

Research Sponsored by Ascentage Pharma Group Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

MM patients (for Arm A and Arm B): Patients with Relapsed/Refractory MM per 2016 IMWG criteria, previously treated with at least 1 but not more than 4 prior lines of therapy for MM. Refractory MM, defined as disease that progresses on salvage therapy or progresses within 60 days of the last treatment.

≥ 18 years of age

Must not have

Currently active, clinically significant cardiovascular disease

Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, APG-2575, combined with pomalidomide and dexamethasone, for patients with relapsed or non-responsive multiple myeloma. The goal is to find the safest and most effective dose. Pomalidomide, combined with dexamethasone, has been shown to be effective in treating relapsed and refractory multiple myeloma, with a history of use demonstrating its safety and efficacy.

Who is the study for?

This trial is for adults with relapsed or refractory multiple myeloma who have had 1-4 prior treatments. They must have good liver and kidney function, a life expectancy of at least 6 months, and be able to perform daily activities with some limitations (ECOG ≤ 2). Women must not be pregnant and all participants should agree to use effective birth control.

What is being tested?

The study tests APG-2575 in combination with two other drug regimens (DRd or Pd) on patients whose multiple myeloma has returned or didn't respond after treatment. It's an early-phase trial that includes increasing doses to find safe levels before expanding the number of patients.

What are the potential side effects?

While specific side effects are not listed here, typical ones may include reactions related to immune system activation, gastrointestinal issues, fatigue, blood-related problems such as anemia or clotting disorders, potential liver or kidney impairment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have MM, treated 1-4 times before, and my condition worsened quickly after the last treatment.

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I am 18 years old or older.

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I am not able to become pregnant or I have a negative pregnancy test.

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I can perform all my self-care activities and remain up and about more than 50% of my waking hours.

Exclusion Criteria

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

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I have a serious heart condition that is currently affecting me.

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I need treatment with a strong medication that affects liver enzymes.

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I do not have any uncontrolled infections.

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I cannot swallow pills or have a condition that affects how my body absorbs nutrients.

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I have had a stem cell transplant from a donor.

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I recently needed treatment for an infection.

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I plan to have a stem cell transplant before my disease worsens on this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days 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 toxicity

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: APG-2575+LDExperimental Treatment1 Intervention

APG-2575+ Lenalidomide +Dexa Days 1 through 21 of each 28-day cycle,

Group II: APG-2575 +Pd or LDExperimental Treatment1 Intervention

APG-2575+ Pomalidomide 4mg QD x 21 days + dexamethasone

0 / 11Eligibility 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

Common treatments for Amyloidosis, particularly those similar to APG-2575 (a BCL-2 inhibitor), work by targeting the pathways that regulate cell survival and apoptosis. BCL-2 inhibitors like APG-2575 promote apoptosis in abnormal plasma cells by disrupting the balance between pro-apoptotic and anti-apoptotic proteins, leading to cell death. Other treatments such as daratumumab (a monoclonal antibody), ixazomib (a proteasome inhibitor), and lenalidomide (an immunomodulatory drug) also aim to reduce the burden of amyloid-producing cells. Daratumumab targets CD38 on plasma cells, ixazomib inhibits protein degradation pathways, and lenalidomide modulates the immune response. These mechanisms are crucial for Amyloidosis patients as they help to reduce the production of amyloid proteins, alleviate symptoms, and improve overall survival.

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