Combination Therapy with Mirdametinib and Sirolimus for Treating RAS Mutated Relapsed Refractory Multiple Myeloma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06876142

Provider View

This study is testing a new treatment using two drugs, mirdametinib and sirolimus, for people with a type of blood cancer called multiple myeloma that has returned or not responded to treatment and has specific gene changes.

Patient Parameters

Program Overview

Multiple myeloma is a blood cancer that affects the immune system. It often comes back after treatment or doesn't respond to initial treatment. Many people with this type of cancer have changes in their KRAS and NRAS genes. This study is testing two drugs, mirdametinib and sirolimus, to see if they can help treat this cancer in people with these gene changes. Participants will take these drugs at home in cycles and have regular check-ups to monitor their health and the treatment's effects.

Description

Multiple myeloma is a common type of blood cancer that often returns after treatment. This study is exploring a new treatment approach for people whose cancer has returned or not responded to treatment and who have specific gene changes (KRAS or NRAS mutations). The treatment involves two drugs, mirdametinib and sirolimus, which are taken by mouth. The study is divided into two parts: the first part will find a safe dose of the drugs, and the second part will see how well the drugs work against the cancer. Participants will take mirdametinib twice a day for three weeks, followed by a one-week break, and sirolimus once a day continuously, in four-week cycles. They will have weekly visits during the first cycle and then monthly visits to monitor their health and the treatment's effects. The treatment will last for one year, followed by regular follow-up visits for four more years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of multiple myeloma.
  • The cancer must have returned or not responded to previous treatments, including specific drugs.
  • Must have changes in the KRAS or NRAS genes.
  • Must be in good overall health with a performance status score of 2 or less.
  • Must have adequate organ and bone marrow function.
  • Women of childbearing potential must agree to use effective contraception during the study and for a period after.
  • Men must agree to use effective contraception and not donate sperm during the study and for a period after.
  • Must not be breastfeeding.
  • If HIV positive, must be on treatment with an undetectable viral load.
  • If Hepatitis C positive, must be treated and cured or have an undetectable viral load.
  • If Hepatitis B positive, must be on suppressive therapy if needed and have a low viral load.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Have received any investigational drugs within 14 days before starting the study treatment.
  • Have received live vaccines within 30 days before starting the study treatment.
  • Have allergies to similar drugs as mirdametinib or sirolimus.
  • Have plasma cell leukemia or amyloidosis.
  • Have severe heart failure or lung disease.
  • Have eye conditions like glaucoma or retinal diseases.
  • Have uncontrolled high blood pressure or diabetes.
  • Are taking certain medications that interact with the study drugs.
  • Have a positive pregnancy test if of childbearing potential.
  • Have an abnormal heart rhythm.
  • Have any other serious illness that could increase the risk of participating in the study.

Get This Program In Your Inbox

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