Dana-Farber research into autologous stem cell transplant for patients with multiple myeloma: study led by Dr. Paul G. Richardson, MD, found patients had dramatically increased progression-free survival, but were just as likely to be alive more than 6 years later if they chose to reserve their transplant until later.
options based on science for patients with multiple myeloma. Results from a pivotal clinical trial called the determination trial paint a clearer picture of the benefits and risks of treatment options including autologous stem cell transplant. It will be truly practice informing by virtue of better understanding where transplant can be used and critically offering patients choices because at the end of the day one size truly does not fit all in myeloma. The study looked at more than 700 patients under the age of 65 with multiple myeloma. It found patients who combined three drugs known as R. V. D. With a stem cell transplant had a dramatically improved progression free survival but they were just as likely to be alive more than six years after treatment if they chose to reserve transplant as a later option. The study found maintaining treatment with a drug called thalidomide in both groups important in delaying progression. What we've shown is that if you look at the primary endpoint, the progression free survival is the best ever we've seen for either arm, be it. Our VD with stem cell harvest and transplant kept in reserve or R. V. D. Plus transplant. Now the critical thing is in both arms wide maintenance was until progression delaying transplant might make sense for some patients because the study also found long term risks associated with it. Namely 10 patients who had the early transplant went on to develop acute myeloid leukemia or myelodysplastic syndrome which are both difficult to treat no patients choosing to delay transplant developed these secondary leukemias. If you're 50 55 years old and you know, you have a transplant and then 15 years later you get secondary leukemia. That is a very challenging prospect. Also important, 18% of study participants were african american. We had the largest african american representation in this trial of any randomized phase three study in myeloma done to date in this setting, which is important because african americans have twice The risk of developing multiple myeloma than whites. All study participants are still being followed for effects on overall survival. And in some cases, researchers are finding the patients who chose to delay transplant are now benefiting from newer drugs and therapies that weren't available when the trial first started more than 10 years ago.