Study on Maintenance Treatment with Isatuximab and Lenalidomide for Multiple Myeloma After Stem Cell Transplant

Sponsor: University of Illinois at Chicago

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05344833

Provider View

This clinical trial is exploring a maintenance treatment using isatuximab and lenalidomide for patients with multiple myeloma who still have minimal residual disease (MRD) after undergoing an autologous stem cell transplant (ASCT).

Patient Parameters

Program Overview

This study is testing a maintenance treatment for patients with multiple myeloma who still have minimal residual disease (MRD) after receiving an autologous stem cell transplant (ASCT). The treatment involves using two drugs, isatuximab and lenalidomide, to help control the disease. Patients can join the study before their transplant or up to 180 days after. They will be monitored for their response to the treatment and for any side effects over a period of three years or until the disease progresses.

Description

This study is for patients with multiple myeloma who have undergone an autologous stem cell transplant (ASCT) and still have minimal residual disease (MRD). The study will test a maintenance treatment using isatuximab and lenalidomide. Patients can have received up to two lines of therapy before their transplant. They can join the study before their transplant or up to 180 days after.

Patients will have their disease reassessed around 90 days after their transplant. If they are MRD-negative, they will receive lenalidomide alone. If they are MRD-positive, they will start treatment with isatuximab and lenalidomide. This treatment must begin before 180 days post-transplant.

Patients will be monitored for their response to the treatment and for any side effects every 12 months for up to three years, or until the disease progresses or they experience unacceptable side effects.

Eligibility Criteria

Inclusion Criteria

  • Must be over 18 years old.
  • Must have a confirmed diagnosis of multiple myeloma, but not smoldering multiple myeloma or plasma cell leukemia.
  • Must not have significant amyloid organ dysfunction.
  • Must be at R-ISS stage 1, 2, or 3 at diagnosis.
  • Must have received up to two lines of therapy before ASCT.
  • Must be planning to undergo or have completed ASCT with high dose melphalan within the last 180 days.
  • Must have achieved at least a partial response before ASCT.
  • Must have an ECOG performance status of 0, 1, or 2.
  • Must have adequate organ function as shown by specific blood tests.
  • Must have access to lenalidomide for use during the study.
  • Must be able to swallow oral medication.
  • Women of childbearing potential and men must agree to use effective contraception during and after the study.
  • Must be willing to take appropriate DVT prevention while receiving lenalidomide.

Exclusion Criteria

  • Cannot be refractory to anti-CD38 monoclonal antibody therapy or lenalidomide.
  • Cannot have had prior intolerance to isatuximab or lenalidomide.
  • Cannot have had a prior allogeneic stem cell transplant.
  • Cannot have had a prior solid organ transplant requiring immunosuppressive therapy.
  • Cannot have another active or progressive cancer requiring treatment.
  • Cannot have known CNS involvement by multiple myeloma.
  • Cannot have taken any investigational drug within 30 days before enrollment.
  • Cannot be part of a tandem autologous transplant approach for newly diagnosed MM.
  • Cannot have uncontrolled illnesses or conditions that would limit compliance with the study.
  • Pregnant women cannot participate due to potential risks to the fetus.
  • Patients with HIV can participate if their viral load is undetectable and they meet other criteria.
  • Patients with active hepatitis B or C cannot participate unless their viral load is controlled and they meet other criteria.

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