A Trial Comparing Single Agent Melphalan to Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preparative Regimen for Patients With Multiple Myeloma Undergoing High Dose Therapy Followed by Autologous Stem Cell Reinfusion
Summary
Third Opinion Trial Synopsis:
Doctors want to compare two different treatments for a type of cancer called Multiple Myeloma. One treatment is called Melphalan and the other is called BEAM. They want to see which one is better at treating the cancer. The doctors think it is okay to do this study because they have already checked that BEAM is safe and the doses they will use are not too strong. Also, there have been other studies that show BEAM works well for another type of cancer called lymphoma. They have looked at how Melphalan is usually used and it does not work very well. They hope the study will show which treatment is better.
Doctors want to compare two different treatments for a type of cancer called Multiple Myeloma. One treatment is called Melphalan and the other is called BEAM. They want to see which one is better at treating the cancer. The doctors think it is okay to do this study because they have already checked that BEAM is safe and the doses they will use are not too strong. Also, there have been other studies that show BEAM works well for another type of cancer called lymphoma. They have looked at how Melphalan is usually used and it does not work very well. They hope the study will show which treatment is better.
*Third Opinion AI Generated Synopsis
Trial Summary
The work proposed herein aims to provide the first prospective, randomized comparative efficacy data between Melphalan and BEAM treatment regimen in the Multiple Myeloma (MM) patient population. The risk of such a study is deemed reasonable and ethical since: a) previous works have closely examined the safety and toxicity of the BEAM regimen and the doses to be delivered in this protocol are well below the toxicity levels; b) phase III trials of BEAM have provided reasonable data regarding the efficacy in lymphomas c) Early, retrospective data suggests that BEAM may be efficacious in MM however due to the lack of prospective controlled randomized clinical trial, there is adequate equipoise regarding its efficacy and moreover its comparative efficacy in relation to Melphalan and; D) there are known limitations in the standard-of-care for MM, Melphalan, namely, relatively low rates of complete response at the time of Autologous stem-cell transplantation (ASCT) and poor progression free survival.
The work proposed herein aims to provide the first prospective, randomized comparative efficacy data between Melphalan and BEAM treatment regimen in the Multiple Myeloma (MM) patient population. The risk of such a study is deemed reasonable and ethical since: a) previous works have closely examined the safety and toxicity of the BEAM regimen and the doses to be delivered in this protocol are well below the toxicity levels; b) phase III trials of BEAM have provided reasonable data regarding the efficacy in lymphomas c) Early, retrospective data suggests that BEAM may be efficacious in MM however due to the lack of prospective controlled randomized clinical trial, there is adequate equipoise regarding its efficacy and moreover its comparative efficacy in relation to Melphalan and; D) there are known limitations in the standard-of-care for MM, Melphalan, namely, relatively low rates of complete response at the time of Autologous stem-cell transplantation (ASCT) and poor progression free survival.
Locations & Contact
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