Study on Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone for Treating Relapsed or Resistant Multiple Myeloma

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04883242

Provider View

This clinical trial is exploring a combination of four drugs—Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone—to treat patients with multiple myeloma that has returned or is not responding to previous treatments.

Patient Parameters

Program Overview

This study is testing a combination of four drugs to see if they can help treat multiple myeloma that has come back or isn't responding to other treatments. Isatuximab is a type of drug that may stop cancer cells from growing. Carfilzomib works by blocking proteins that cancer cells need to grow. Pomalidomide may help slow down or shrink the cancer. Dexamethasone is used to reduce inflammation and is often combined with other cancer drugs. The goal is to see if using these drugs together can kill more cancer cells.

Description

Treatment Plan:

  • Induction Phase: Patients will receive Isatuximab through an IV on specific days of the first cycle and then on fewer days in the following cycles. Carfilzomib is given through an IV over 30 minutes on certain days, while Pomalidomide is taken by mouth daily for most of the cycle. Dexamethasone can be taken by mouth or through an IV on specific days. This treatment cycle repeats every 28 days for up to 6 cycles unless the disease worsens or side effects become too severe.

  • Maintenance Phase: After the induction phase, patients continue with Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone on a similar schedule, but the cycles can repeat every 28 days for up to 24 months, as long as the disease does not progress and side effects are manageable.

Monitoring:

  • Patients will have bone marrow tests, imaging scans like X-rays, CT, PET-CT, or MRI, and blood tests throughout the study to monitor their condition.

Follow-Up:

  • After finishing the study treatment, patients will have follow-up visits 30 days later and then periodically for up to 5 years to check on their health.

Eligibility Criteria

Inclusion Criteria

  • Have multiple myeloma that has returned or is not responding to treatment, with at least one previous therapy.
  • Must have previously received lenalidomide treatment.
  • Must have measurable disease based on specific medical criteria, such as certain levels of proteins in the blood or urine, or specific findings in bone marrow or tumors.
  • Be 18 years or older and able to give informed consent.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Any side effects from previous treatments should be mild or resolved, except for mild nerve damage.
  • Previous stem cell transplant is allowed if it was at least 6 months ago.
  • Have adequate kidney function and liver enzyme levels within specified limits.
  • Have sufficient blood cell counts, which can be supported by growth factors or transfusions if needed.
  • Agree to use effective birth control during and after the study for a specified time.

Exclusion Criteria

  • Have significant heart disease, such as severe heart failure or recent heart attack.
  • Have uncontrolled high blood pressure.
  • Have active plasma cell leukemia or a specific type of amyloidosis.
  • Have another primary cancer that hasn't been in remission for at least a year, except for certain non-threatening cancers.
  • Have active hepatitis B or C infections unless they are well-controlled or cured.
  • Have an active, uncontrolled infection.
  • Are using other cancer treatments or experimental drugs.
  • Have received anti-CD38 antibody therapy in the last 90 days.

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