Study on Venetoclax, Daratumumab, and Dexamethasone for Systemic Light-Chain Amyloidosis with Chromosome Change (ALTITUDE)

Sponsor: Alfred Chung, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05486481

Provider View

This clinical trial is testing a combination of three drugs—venetoclax, daratumumab, and dexamethasone—to treat systemic light-chain amyloidosis in patients with a specific DNA change involving chromosomes 11 and 14. The study aims to find the safest and most effective dose of these drugs and to see how well they work together.

Patient Parameters

Program Overview

This study is exploring a new treatment for systemic light-chain amyloidosis, a condition where abnormal proteins build up in organs. The treatment combines three drugs: venetoclax, which targets a protein to kill cancer cells; daratumumab, which helps the immune system find and destroy cancer cells; and dexamethasone, which reduces inflammation. The study is in two phases: Phase I will determine the safest dose, and Phase II will evaluate how well the treatment works in patients with a specific genetic change called t(11;14).

Description

The study is divided into two phases. In Phase I, researchers will determine the safest dose of venetoclax, with or without daratumumab and dexamethasone, for patients who have already been treated for light-chain amyloidosis and have the t(11;14) genetic change. In Phase II, the effectiveness of the drug combination will be assessed by measuring how well it reduces the disease in these patients.

Participants will take venetoclax daily, and depending on their treatment group, they may also receive dexamethasone and daratumumab at specific times during each 28-day cycle. The treatment can continue for up to two years unless the disease worsens or side effects become unacceptable.

After completing the treatment, participants will have follow-up visits to monitor their health and the study's effects. These visits will occur 30 days after treatment ends and every three months until the last participant completes two years of treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Diagnosed with amyloidosis confirmed by specific lab tests.
  • Have a specific genetic change called t(11;14) in bone marrow cells.
  • Have received at least one prior treatment for systemic AL amyloidosis.
  • No previous treatment with CD38-directed antibodies, or if treated, must have responded well and not progressed during treatment.
  • Have measurable disease as defined by specific lab criteria.
  • Have one or more organs affected by AL amyloidosis.
  • Be in good overall health with a performance status of 2 or less.
  • Meet specific blood and organ function criteria based on lab tests.
  • Completed any previous treatments or surgeries within specified timeframes before starting the study.
  • Women of childbearing potential must use effective birth control during and after the study.
  • Men must use birth control and not donate sperm during and after the study.
  • Must have received specific vaccinations.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Progressed on CD38 antibody therapy within 90 days of the last dose.
  • Previous use of BCL-2 inhibitors.
  • Intolerance to specific antibody therapies.
  • Diagnosed with multiple myeloma or other types of amyloidosis.
  • Significant heart conditions or recent heart-related hospitalizations.
  • Planned stem cell transplant.
  • Recent history of other cancers, except for certain non-threatening types.
  • Severe lung conditions or uncontrolled asthma.
  • Positive for HIV, hepatitis B, or hepatitis C, unless under control.
  • Other medical conditions that could interfere with the study.
  • Not recovered from previous cancer treatment side effects.
  • Use of certain medications or foods that could interfere with the study.
  • Recent major surgery or planned surgery during the study.
  • Unable to comply with study requirements.
  • Pregnant or breastfeeding women, or those planning to become pregnant during or shortly after the study.
  • Recent vaccination with live vaccines.

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