With flow cytometry, we’re talking about making the test more sensitive and specific for myeloma. That will involve just a bit of tweaking. There are computer software programs that will need a new algorithm with a slightly different cocktail for folks with myeloma.
Once that is done, we’re very optimistic about getting the test into use, because this type of flow cytometry is widely used at centers across the country and world.
It will be possible to roll this out rather quickly and make it widely available for diagnosis without FDA approval, because it simply involves modifications of existing technology that has been approved for use in the US and most countries.
No new machines will be needed to conduct the updated versions of these tests.
What kind of timeline do you envision for this project?
We’re hopeful to have both the flow cytometry and molecular testing available in the next three to six months.
Then, in the following 2½ years, we will conduct validation of the tests, primarily within clinical trials and at no cost to patients. Part of our work will be to identify patients who have been in complete remission for 10 years, and evaluate them to see if they have achieved MRD zero. Then, we’ll be able to correlate the test to say, “This level of MRD does correlate with 10-year survival.”
After that, there will be meetings with the FDA, which will require validation information to approve MRD as an accepted endpoint. A primary goal of the Black Swan Research Initiative is to acquire and submit the necessary documentation as rapidly as possible—hopefully in 2014.
Once all that has been completed, the IMF anticipates releasing new guidelines for myeloma treatment with MRD as an endpoint.
In addition to eliminating uncertainty for patients, what outcomes do you anticipate as a result of this project?
We’ll have the confidence to treat more aggressively in the first six months to get to that MRD zero. We’ll front-load the therapy, and, if we achieve MRD zero, we’ll be able to stop treatment. There will be some patients in whom we also want to use maintenance therapy, but, in general, this is going to reduce the amount of treatment.
In addition, trials will be much faster. You could have an endpoint of MRD zero after six months, instead of a specified outcome after five to 10 years. This would dramatically shorten trials and reduce their cost.
Where is the funding for this project coming from?
The foundation has sought and been receiving private funding. In addition, we are seeking corporate sponsors. We would like to see pharmaceutical companies fund trials of their drugs that will test the ability of the agents to get patients to MRD zero.