Evaluating the effectiveness and safety of an all-oral combination of ixazomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma undergoing stem cell transplantation.

This study evaluated the effectiveness and safety of an all-oral combination of ixazomib (Ninlaro), lenalidomide (Revlimid), and dexamethasone (Decadron) in transplant-eligible patients with newly diagnosed multiple myeloma (MM). The data showed that this combination was effective with manageable side effects in these patients.

MM is a type of cancer that comes from blood cells called plasma cells. The current recommended treatment for newly diagnosed MM involves first-line treatment with lenalidomide in combination with dexamethasone (Decadron) and bortezomib (Velcade), followed by autologous stem cell transplantation (ASCT) and maintenance therapy. ASCT involves transplanting healthy stem cells from the same patient. Lenalidomide is an immunotherapy drug which boosts the body’s immune system to help it attack cancer cells.

Maintenance therapy is usually recommended after first-line treatments to delay relapse or slow down cancer progression in patients. Common maintenance therapy includes treatment with proteasome inhibitors (PIs) such as ixazomib. Proteasomes are large molecules present in all body cells. They break down and remove damaged proteins. MM cells rely on proteasomes to multiply and spread. Ixazomib blocks the action of proteasomes, therefore preventing myeloma cells from growing and multiplying.

Studies have shown ixazomib to be effective for the treatment of patients with newly diagnosed MM. However, the effectiveness and safety of an all-oral triplet combination of ixazomib, lenalidomide, and dexamethasone (IRD) in transplant-eligible patients with newly diagnosed MM are still unknown.

This study involved 42 patients with transplant-eligible newly diagnosed MM. All patients received an all-oral triplet combination of ixazomib (4 mg), lenalidomide (25 mg), and dexamethasone (40 mg) as an induction and consolidation regimen. Patients then underwent ASCT followed by consolidation therapy with 28 cycles of IRD and maintenance therapy with ixazomib (4 mg/day) for one year. The average follow-up time was 62.6 months.

The overall response rate (ORR; the partial or complete disappearance of the cancer) was 80%. 30% of the patients achieved a very good partial response. 12% of the patients achieved a complete response by the end of induction. 41% of the patients achieved a complete response by the end of consolidation.

The average survival without cancer worsening was 41.8 months. After 3 years, 92.8% of the patients were alive.

The most common side effects were low white blood cell counts, skin rash, low platelet counts, and lung infection.

This study concluded that an all-oral triplet combination with ixazomib, lenalidomide, and dexamethasone was effective with manageable side effects in transplant-eligible patients with newly diagnosed MM.

The sample size was very small. There was no control arm. Larger studies are necessary to validate the conclusions.