At 2022 ASCO, Paul G. Richardson, MD, dives into results of the DETERMINATION study, which examined triplet therapy with lenalidomide plus either lenalidomide maintenance until progression or autologous stem transplantation in newly diagnosed multiple myeloma.
At the 2022 American Society of Clinical Oncology Annual Meeting, Paul G. Richardson, MD, clinical program leader and director of clinical research for the Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute as well as RJ Corman Professor of Medicine at Harvard Medical School, both in Boston, Massachusetts, spoke with CancerNetwork® about efficacy of continuous lenalidomide (Revlimid) maintenance following triplet therapy vs autologous stem cell transplant (ASCT) in patients with newly diagnosed multiple myeloma in the phase 3 DETERMINATION trial (NCT01208662).
One thing we’re very proud of in the study is that we were very diverse in our centers, and our patient population reflected that. We had the highest representation of African American patients in any phase 3 myeloma trial to date at approximately 20%, so this was a first. In the same context, we were able to enroll patients according to the protocol and demonstrate clearly that the use of early transplant was associated with a dramatic benefit in terms of progression-free survival.
We saw median progression-free survival in the transplant-early arm of 67.6 months and we showed it to be 46.2 months in the transplant-delayed group [HR, 1.53; 95% CI, 1.23-1.91; P <.0001]. These are the best [outcomes] in both groups. Now the difference of 21 months was impressive to us, we’d anticipated at least 12 months. The fact that it went [that long] was striking. Despite that event-free or progression-free survival gain, we did not see an overall survival difference. With mature follow-up approaching 7 years, we do not see any difference in survival, it’s identical at around 80%.
When we looked at salvage treatments in the delayed-transplant arm—we gave patients and providers the choice [to go on to ASCT] and they weren’t required to do it—we showed that 28% of the patients had had a salvage transplant or a delayed transplant. That meant that 72% received other treatments and therein lies an important message because by using monoclonal antibodies, novel treatments such as pomalidomide [Pomalyst], other small molecule strategies, and proteasome inhibitors, we were able to see an equivalent survival.
Richardson PG, Jacobus SJ, Weller E, et al. Lenalidomide, bortezomib, and dexamethasone (RVd) ± autologous stem cell transplantation (ASCT) and R maintenance to progression for newly diagnosed multiple myeloma (NDMM): The phase 3 DETERMINATION trial. J Clin Oncol. 2022;40(suppl 17):LBA4. doi:10.1200/JCO.2022.40.17_suppl.LBA4