The StaMINA trial was one of the largest myeloma trials, transplant trials, in the United States. It randomised about 700 patients and it asked the question what’s the best thing to do after an initial autologous transplant to prolong remission for patients? There were three arms: one arm was a tandem transplant, one arm was RVD consolidation and one arm was going straight to maintenance therapy.
How many patients were involved?
It was about 750 patients and, just to expand, what we presented at this meeting was the subgroup analysis of that trial looking at patients who had high risk cytogenetics and asking the question what was the best intervention after that initial transplant for them. What we showed was in fact that doing just a single auto followed by len maintenance was equivalent to doing a tandem autologous transplant or RVD consolidation, even for patients with high risk cytogenetics. Having said that, some of the data presented in today’s session which was a global multiple talks on transplant, in fact, our European colleagues had somewhat of a similar trial looking at single and tandem transplant and consolidation and they found something different. They in fact found that patients who had high risk cytogenetics benefitted from a tandem autologous transplant. So today’s session really we spent a lot of time trying to dissect the differences because these are two huge trials and their trial was almost 1,000 patients in Europe, 700 patients in the United States, and how do you reconcile somewhat differing results. To be honest, we didn’t come up with any clear conclusions, not surprisingly, in the way things work but we did come up with certain points which is that for most of us we’re not ready to abandon consolidation. What we’re waiting for is more data really seeing what’s your depth of response after initial induction therapy, after an initial transplant, and maybe that will drive your future decision making.
So part of what we talked about today also was future trials which are going to incorporate some of the even newer agents such as antibodies which also may drive us because we now know antibody combinations are particularly good at getting patients to an MRD negative state and that may be the ultimate driver of all of this.
What is likely to change as a result of this?
In the United States right now if you are a Trump supporter, you’re a Trump supporter, you don’t matter what anyone says and it’s kind of the same thing for these trials. So if you believe that lenalidomide maintenance is standard of care, best approach, nothing else is shown truly in this randomised trial then you can say, ‘Yes, nothing else is shown to beat it.’ But if you still don’t in your heart believe that then you can pick apart the data and say the RVD consolidation arm, for example, and high risk cytogenetics was not statistically significant but there was a trend to better progression free survival. Maybe there’s a certain subgroup of patients that we don’t know yet, if we look deeper, really will still benefit from some intensification after that first transplant.