Myeloma, also called multiple myeloma, is a blood cancer that starts in plasma cells. Plasma cells are a type of white blood cell found in the bone marrow. Healthy plasma cells make antibodies, which are proteins that help the body fight infections. As myeloma cells build up in the bone marrow, they can crowd out healthy cells. The body may then make fewer antibodies that fight infections.

Patients with newly diagnosed myeloma usually begin treatment with a combination of three or four drugs that target the cancer in different ways to control the disease. Some people then have a stem cell transplant, based on their overall health and treatment plan. Many people continue to take medicine to help keep myeloma under control, whether or not they had a stem cell transplant. However, myeloma is usually not curable, and sometimes the cancer comes back (relapses).

For some patients, myeloma comes back during or soon after their first treatment. This is called an early relapse. Doctors do not yet know which treatment approach works best for these patients.

Researchers at the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) have opened the EAA242 clinical trial to test a new treatment approach for patients with early relapse. The trial compares a treatment that contains two drugs that help the immune system fight myeloma with a standard three-drug treatment.

The two-drug combination consists of teclistamab (tek-LIS-tuh-mab) and pomalidomide (PAH-muh-LIH-doh-mide). Doctors already use these drugs together for some patients whose myeloma has come back or no longer responds to treatment. Researchers want to see whether giving the two drugs together earlier leads to better results.

EAA242 is for people who have an early relapse of myeloma after a treatment plan that included the drug Revlimid® (lenalidomide). They must also have received Darzalex® (daratumumab) or Sarclisa® (isatuximab). Patients who have received more than two courses of treatment are not eligible. The first set of drugs, a stem cell transplant, if given, and medicine taken afterward to keep myeloma under control all count together as one course of treatment.

This trial has two phases. In phase 1, up to 12 patients will receive the two-drug treatment. Researchers will test two dose levels of pomalidomide to check for side effects and determine which dose to use with teclistamab in phase 2.

Phase 2 will enroll up to 150 patients. They will be randomly assigned by a computer to one of two treatment groups. The control group will receive a standard three-drug treatment that includes a targeted drug, pomalidomide, and a steroid. The other group will receive teclistamab and pomalidomide, using the pomalidomide dose chosen in phase 1.

After about 8 months of treatment, phase 2 patients will have a bone marrow test to look for any remaining myeloma cells. Researchers will compare how many people in each group have no signs of myeloma on standard tests and no myeloma cells detected by the more sensitive bone marrow test.

Patients in both groups can keep receiving treatment as long as the cancer does not get worse and they can manage side effects. Those in the two-drug group can receive treatment for up to 2 years.

This study is led by Murali Janakiram, MD, of the City of Hope Comprehensive Cancer Center.

Learn more about EAA242 at ecog-acrin.org.