The treatment of smoldering myeloma is advancing based on what myeloma researchers are learning in recent studies. One of the most important points discussed at the recent ASCO conference were how to better risk stratify smoldering myeloma patients.
Dr. Natalie Callander from the University of Wisconsin shared a study from smoldering myeloma patients that began in 2004. In the study, they developed a new system called 20-2-20. If a person has more than 20% plasma cells in the bone marrow, if their M-spike is above 2 grams and if their free light chain ratio is above 20, then that can be considered higher risk myeloma. The research showed that this was more indicative of a 50% change of progression in a 4 year time period.
She also shared the results presented at ASCO by Sagar Lonial, MD of Emory University. This is the longest running study of smoldering myeloma patients that shows that using lenalidomide is better than simple observation for smoldering myeloma. The study group looked at progression free survival (PFS) at 1, 2 and 3 years and the lenalidomide group had significantly longer PFS for all three time periods. The conclusion from this study was that all high risk smoldering myeloma patients should get treated with something, and preferably on a clinical trial so results can be tracked.
Dr. Callander shared the new DETER-SMM trial to expand the learning of this earlier trial. This trial is for high risk smoldering myeloma patients who have over 10% plasma and more than 3 grams of M-protein or high risk genetic features of the 4;14 translocation, or the 1gain or deletion of 17p.
In this open study, daratumumab (intravenous) with lenalidomide and dexamethasone will be compared with lenalidomide and dex alone.
The drugs will be given in a tiered way. Daratumumab will be given intravenously. Lenalidomide will be given for two years and then stopped. Dexamethasone will be given for 6 months at a regular dose, dropped to 20 mg for another 6 months and then stopped.
In the second group, patients will receive lenalidomide and dex with the same dosing and frequency. There will be no observation arm.
The study will look at minimal residual disease and PET scans, which can indicate progression of disease.
All drugs are provided as part of the study, so there is no drug cost to participants.
To learn more about this study, click here: