Study on Eliminating Minimal Residual Disease After Transplant in Multiple Myeloma Patients

Sponsor: Medical College of Wisconsin

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05690984

Provider View

This clinical trial is exploring a treatment to eliminate remaining cancer cells in the bone marrow of multiple myeloma patients after they have undergone a stem cell transplant. The study will use a combination of medications to see if it can effectively reduce these residual cancer cells.

Patient Parameters

Program Overview

This study is focused on patients with multiple myeloma who still have small amounts of cancer cells in their bone marrow after receiving a stem cell transplant. The trial will test a combination of three drugs—isatuximab, lenalidomide, and dexamethasone—over a year to see if it can eliminate these remaining cancer cells. The main goal is to determine how effective this treatment is in achieving a negative result for minimal residual disease (MRD) in the bone marrow, as measured by a specific test called clonoSEQ®. The study will also look at how well patients tolerate the treatment and how it affects their cancer at a molecular level.

Description

Thirty-one patients will participate in this study at Froedtert Hospital and the Medical College of Wisconsin Cancer Center. Participants will receive a combination of three drugs: isatuximab, lenalidomide, and dexamethasone (known as IsaRD) for 12 cycles, each lasting 28 days. The primary aim is to see if this treatment can reduce the presence of cancer cells in the bone marrow to a very low level, as measured by a test called clonoSEQ®. The study will also evaluate how well patients tolerate the treatment and its overall effectiveness in controlling the disease.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Must have a bone marrow sample from diagnosis available for testing.
  • Have residual cancer cells in the bone marrow 90-120 days after a stem cell transplant, as detected by a specific test.
  • Have a confirmed diagnosis of symptomatic multiple myeloma.
  • Have received a stem cell transplant within one year of diagnosis.
  • Have adequate organ function, including specific blood cell counts and liver enzyme levels.
  • Women must not be pregnant and must use effective contraception during and after the study. Men must also use contraception and avoid donating sperm during and after the study.
  • Must be registered in the Revlimid REMS® program and comply with its requirements.
  • Must understand and sign a written informed consent document.

Exclusion Criteria

  • Evidence of disease progression before joining the study.
  • Receiving or planning to receive other treatments for multiple myeloma during the study, except for local radiation or corticosteroids for other conditions.
  • Serious medical or psychiatric conditions that could interfere with the study.
  • Previous organ transplant requiring immunosuppressive therapy.
  • Positive for HIV or active hepatitis A, B, or C infections.
  • Allergy to any study medications or their components.
  • Other cancers requiring treatment.
  • Severe heart conditions or recent heart attack.
  • Major surgery within 14 days before starting the study.
  • Recent serious infection requiring antibiotics.
  • Participation in other clinical trials within 30 days before starting the study.
  • Any uncontrolled medical conditions that pose a risk or interfere with the study.
  • Allergies to components of the study drugs that cannot be managed with premedication.
  • Pregnant or breastfeeding individuals.

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