The Role of Ixazomib in Autologous Stem Cell Transplant in Relapsed Myeloma - Myeloma XII (ACCoRd)

This study is looking for adults aged 18 or over who have multiple myeloma that has come back at least a year after their first stem cell transplant. You'll need to be generally well enough to take part, meaning you can mostly look after yourself and manage daily activities without too much difficulty.

Your blood test results will need to be within a healthy range, especially for blood counts, and your kidneys, liver, lungs, and heart will need to be working adequately. This helps make sure that the treatments in the study are as safe as possible for you. If you are female and able to become pregnant, you would need to agree to use effective contraception during and for a period after the study treatment.

There are also specific medical details about your myeloma and its progression that the doctors will check against the study's requirements. This includes having 'measurable disease,' which simply means your doctors can track your cancer effectively to see if the treatment is working.

If you join this study, you'll first receive a combination of three drugs: ixazomib, thalidomide, and dexamethasone (we call this ITD) for about 4 to 6 cycles, each lasting 28 days. The aim of this initial treatment is to get your myeloma under as much control as possible.

If this initial treatment works well enough (meaning your disease is stable or better), you'll then be randomly assigned to one of two groups for your stem cell transplant. One group will have the standard stem cell transplant with a drug called melphalan, and the other group will have a boosted transplant, where ixazomib is added to the melphalan. This random assignment is like flipping a coin, ensuring a fair comparison.

After your transplant, if your myeloma continues to be well-controlled, you'll have a second random assignment. You'll either receive no further treatment, or you'll go into a ‘consolidation and maintenance’ phase. This involves two more cycles of the ITD combination, followed by ongoing treatment with ixazomib until your cancer progresses. Throughout the study, you'll have regular hospital visits for blood tests, check-ups, and to monitor how you're feeling and how the treatment is working. We will also monitor your quality of life.