Adriana C. Rossi, MD, Associate Director of the Myeloma Program, Weill Cornell Medicine, New York, discusses a phase 2 study of high-dose lenalidomide with high-dose melphalan as a conditioning regimen for autologous stem cell transplantation (ASCT) in patients with relapsed/refractory (R/R) multiple myeloma (MM). These data are being presented at the virtual 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

Transcript

Hi, my name is Adriana Rossi. I am an associate director of the Myeloma Program at Weill Cornell Medicine in New York.

Autologous stem cell transplant has been a standard of care for myeloma for decades. So far, the only approved regimen we have is high-dose melphalan. Over the years, we have tried different combinations with radiation or with drugs such as busulfan and bortezomib, but so far, nothing has proved superior than the single agent.

The introduction of lenalidomide has changed the landscape of myeloma and therapy for our patients. When we first started studying it, we saw that there's a clear dose-response curve, but we are limited by myelosuppression. Our thought was in the setting of stem cell reconstitution, could we push the dose of lenalidomide to get a maximal benefit and overcome that toxicity with the use of stem cells?

We studied 50 patients with relapsed myeloma. Many of whom had prior transplants, and many of whom came into the study with progressive disease. We used a regimen of the 200 of melphalan, which is standard, and additionally added 350 mg daily for 5 days of lenalidomide.

At day 100, the overall response rate was 96%, being that over 80% were VGPR or greater. A remarkable depth of response for patients who are very high-risk. The response was regardless of prior transplantation, regardless of prior lenalidomide, and regardless of high-risk cytogenetics.

We are very encouraged by the findings so far and if we can improve our current practice for transplant and using 2 drugs get deeper responses and be able to salvage patients with limited options, this could be practice-changing.

I think this was a very valuable proof of concept and really merits further investigation either moving forward with a greater patient cohort and having a comparative arm, so a randomized control study, or also we are considering other agents that we could use, be that pomalidomide or the CELMoDs that are coming into practice.