Study on Bortezomib, Isatuximab, Cyclophosphamide, and Dexamethasone for Multiple Myeloma Patients Eligible for Transplant

Sponsor: Medical College of Wisconsin

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04240054

Provider View

This clinical trial is testing a new combination of drugs to see if it is safe and effective for patients with multiple myeloma who are eligible for a stem cell transplant. The study includes patients with kidney issues due to myeloma.

Patient Parameters

Program Overview

This study is exploring whether adding the drug isatuximab to a combination of bortezomib, cyclophosphamide, and dexamethasone (VCD) can improve treatment outcomes for patients with newly diagnosed multiple myeloma who are eligible for a stem cell transplant. The main goal is to see if this combination can help more patients achieve a significant reduction in cancer symptoms, even if they have kidney problems related to myeloma.

Description

The study is designed to test if adding isatuximab to the standard VCD treatment is safe and effective for patients with multiple myeloma who are preparing for a stem cell transplant. Researchers hope that this combination will lead to better treatment responses, especially in patients with kidney issues caused by myeloma. The study will measure how many patients achieve a very good partial response (VGPR) after treatment, as defined by international criteria. Participants will receive the treatment before undergoing a stem cell transplant, and their progress will be closely monitored.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate in the study.
  • Must be 18 years or older.
  • Eligible for high-dose therapy and stem cell transplant according to hospital guidelines.
  • No previous treatment for multiple myeloma, except for specific doses of dexamethasone, bortezomib, or cyclophosphamide for managing acute symptoms.
  • Must have documented multiple myeloma with specific criteria, including:
    • Monoclonal plasma cells in the bone marrow or a biopsy-proven plasmacytoma.
    • Evidence of organ damage or myeloma-defining events, such as high calcium levels, anemia, or kidney issues.
    • Measurable disease, such as specific levels of M-protein or light chains in the blood or urine.
  • ECOG performance status of 0-2, indicating good overall health.
  • Women of childbearing potential and men with partners of childbearing potential must use effective contraception during the study and for 16 weeks after the last dose.
  • Women must agree not to donate eggs during the study and for 16 weeks after the last dose.
  • Men must agree to use barrier contraception or practice abstinence during the study and for four months after the last dose.

Exclusion Criteria

  • Patients who need immediate treatment for kidney failure.
  • History of other cancers, except those treated with curative intent and no active disease for at least three years.
  • Signs of central nervous system involvement by multiple myeloma.
  • Positive for HIV, hepatitis B, or untreated hepatitis C.
  • Medical conditions that could interfere with the study or pose a risk to the patient.
  • Significant heart disease or uncontrolled heart conditions.
  • Abnormal blood test results, such as low blood cell counts or high liver enzymes.
  • Allergies or intolerances to study drugs or similar medications.
  • Specific types of blood disorders or conditions like plasma cell leukemia or amyloidosis.
  • Unable to comply with study requirements due to other health issues or personal circumstances.
  • Pregnant or breastfeeding women, or those planning to become pregnant during the study.
  • Men planning to father a child during the study.
  • Recent major surgery or planned surgery during the study period.
  • Uncontrolled lung disease or history of pneumonitis.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.