Comparing Dara-VCD Chemotherapy with and without Stem Cell Transplant for Newly Diagnosed AL Amyloidosis

Sponsor: SWOG Cancer Research Network

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06022939

Provider View

This study is exploring whether adding a stem cell transplant to the standard chemotherapy treatment (Dara-VCD) can improve outcomes for patients with newly diagnosed AL amyloidosis. The trial will compare the effects of chemotherapy alone versus chemotherapy followed by a stem cell transplant.

Patient Parameters

Program Overview

This phase III clinical trial is investigating if adding a stem cell transplant after chemotherapy with daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-VCD) is more effective than using Dara-VCD alone for treating newly diagnosed AL amyloidosis. The process involves using chemotherapy to kill cancer cells and make space in the bone marrow for new stem cells, which are then transplanted back into the patient. Daratumumab is a monoclonal antibody that targets cancer cells, while cyclophosphamide and bortezomib are chemotherapy drugs that stop cancer cells from growing. Dexamethasone helps reduce the immune response to aid in cancer treatment. The study aims to see if the addition of a stem cell transplant can kill more cancer cells and improve patient outcomes.

Description

The main goal of this study is to compare how well patients do without their major organs getting worse when they receive either the standard chemotherapy treatment (Dara-VCD) alone or with an added stem cell transplant. Researchers will also look at overall survival rates, how well the heart and kidneys respond to treatment, and any side effects experienced by patients in both groups.

Additional goals include examining the best blood response rates and how long patients stay free from disease progression. The study will also explore the use of delayed stem cell transplants for those who initially receive only chemotherapy.

Participants will undergo various tests and procedures, including blood and urine tests, imaging scans, and bone marrow biopsies, to monitor their health and response to treatment. The study will also assess patients' quality of life and any symptoms they experience during treatment.

The trial is structured in several steps:

  • Induction Phase: Patients receive Dara-VCD chemotherapy for up to three cycles.
  • Consolidation Phase: Patients who respond well to the initial treatment are randomly assigned to either continue with Dara-VCD or receive a stem cell transplant.
  • Maintenance Phase: Patients receive ongoing treatment with daratumumab to help maintain their response to therapy.

Participants will be followed up regularly for up to four years to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of AL amyloidosis with specific test results.
  • Must have measurable disease based on certain lab tests.
  • Can have received up to one cycle of similar treatment before joining the study.
  • Must be 18 years or older.
  • Must be in good general health with a performance status score of 0, 1, or 2.
  • Must be willing to undergo high-dose chemotherapy and stem cell transplant if assigned to that group.
  • Must have adequate blood counts and organ function based on specific lab tests.
  • Must not have certain other medical conditions, such as uncontrolled infections or other cancers that could interfere with the study.
  • Must not be pregnant or breastfeeding and must agree to use effective contraception if of reproductive potential.
  • Must be willing to provide blood and tissue samples for research purposes.
  • Must be able to complete quality of life questionnaires in English, Spanish, or French.
  • Must agree to follow all study procedures and attend follow-up appointments.

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