Post autologous transplant therapies in high risk multiple myeloma: StaMINA trial update

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Published: 2 Mar 2017
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Dr Amrita Krishnan - City of Hope Cancer Center, Duarte, USA

Dr Krishnan speaks with ecancer at the 16th International Myeloma Workshop about the StaMINA trial, which looked at autologous haematopoietic cell transplant (autoHCT) followed by lenalidomide maintenance vs auto HCT and lenalidomide and bortezomib and dexamethasone consolidation lenalidomide maintenance vs tandem autoHCT lenalidomide maintenance 

The primary results of the largest randomised US transplant trial in multiple myeloma demonstrated comparable progression free survival (PFS) and overall survival (OS).

The addition of dexamethasone consolidation or a second auto HCT was not superior to a single auto HCT followed by lenalidomide maintenance in the upfront treatment of multiple myeloma.

Tandem autoHCT did not improve PFS or OS compared to single Auto HCT.

Consolidation therapy with revlimid-velcade-dexamethasone had a trend towards improved PFS at 38 months but did not achieve statistical significance. However, the high 38 month survival in all arms is encouraging and is in keeping with the high PFS of the lenalidomide maintenance arms in the Myeloma XI trial (median PFS 60 months) and CALGB100104 (median PFS 53 months).

Alternate strategies such as combinations with monoclonal antibodies pre and post transplant may lead to further improvements in PFS and OS in high risk patients.

A long term follow-up trial to track outcomes in these patients is ongoing.

Dr Krishnan also spoke with ecancer about ongoing transplantation trials.

ecancer's filming has been kindly supported by Amgen through the ECMS Foundation. ecancer is editorially independent and there is no influence over content.

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.