Study on Using Minimal Residual Disease to Delay Transplant in Multiple Myeloma Patients (MILESTONE)

Sponsor: University of Alabama at Birmingham

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04991103

Provider View

This clinical trial is exploring whether using a new method to detect minimal residual disease can help delay the need for a stem cell transplant in patients with newly diagnosed multiple myeloma.

Patient Parameters

Program Overview

The study aims to find out if a new approach using next-generation sequencing to detect minimal residual disease (MRD) can help decide when to delay a stem cell transplant in patients with newly diagnosed multiple myeloma. This could potentially reduce the side effects and long-term risks associated with the transplant.

Description

While stem cell transplants are a key treatment for multiple myeloma, they can cause significant side effects and long-term health issues. This study is investigating whether delaying the transplant based on the presence of minimal residual disease (MRD) can be a safer option for patients. The study will use advanced sequencing techniques to detect MRD and determine if this approach can help avoid unnecessary transplants, improving patients' quality of life and potentially extending their life expectancy.

Eligibility Criteria

Inclusion Criteria

  • Adults over 18 years old with newly diagnosed multiple myeloma who need treatment and have a performance status of 0-2.
  • No previous treatment except for specific medications like dexamethasone, bortezomib, or cyclophosphamide for managing symptoms, used for no more than 4 weeks before joining the study.
  • Measurable disease with specific levels of monoclonal protein in the blood or urine, or abnormal free light chain levels.
  • Expected to live at least 12 months.
  • Good liver and kidney function based on specific blood tests.
  • Women of childbearing age must agree to regular pregnancy tests and use birth control during treatment and for 30 days after the last dose of bortezomib. Men must use birth control and avoid donating sperm during treatment and for 90 days after the last dose.
  • Agree to participate in the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program.
  • Eligible for stem cell transplant based on the investigator's assessment.
  • The study aims to include at least 30% participants from ethnic/racial minority groups.

Exclusion Criteria

  • Diagnosed with POEMS syndrome or Waldenstrom's macroglobulinemia.
  • Major surgery, radiation, or infection treatment within 14 days before starting the study.
  • Pregnant or breastfeeding women.
  • Uncontrolled HIV, hepatitis B, or hepatitis C infections, unless the viral load is undetectable.
  • Recent heart issues like unstable angina or heart attack within 4 months, severe heart disease, or certain heart rhythm problems unless a pacemaker is present.
  • History of stroke or mini-stroke within the last year.
  • Other cancers within the last 3 years, except for certain skin cancers, localized thyroid cancer, or other cancers considered cured or unlikely to affect survival during the study.
  • Significant nerve damage or pain within 21 days before joining the study.
  • Any other serious medical condition that might interfere with the study or the ability to give informed consent.

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