Multiple Myeloma Protocols
Please check with your physician for additional protocols and/or information.
1. S1211: A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)
One of the standard treatments for High Risk Multiple Myeloma is the combination of bortezomib, lenalidomide and dexamethasone (RVD). Elotuzumab is an experimental cancer drug. It is currently being tested in cancer patients. There are laboratory results that suggest that RVD might work better if elotuzumab is added.
2. S1304: A Phase II Randomized Study Comparing Two Doses of Carfilzomib (NSC-756640) with Dexamethasone for Multiple Myeloma Patients with Relapsed or Refractory Disease
The purpose of this study is to find out what effects, good and/or bad, adding the drug carfilzomib to regular treatment with dexamethasone has on you and your disease. We would like to compare a higher dose of carfilzomib to the lower dose that is usually used to find out which is better. The lower dose of carfilzomib is approved for treatment of your cancer. The higher dose is experimental. Therefore, carfilzomib is experimental for this study.
3. E3A06: Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma
The purpose of this study is to find out what effects (good and bad) the use of the drug lenalidomide has on you and your multiple myeloma, and to compare this with patients that receive no therapy. Currently, the accepted treatment for asymptomatic myeloma is to receive no therapy. However, not all patients with asymptomatic (smoldering) myeloma have the same outcome. There are 3 groups of patients as identified by the Mayo clinic group that have different predicted outcomes. Because the 3 groups can have very long delays between the identification of smoldering myeloma and the requirement for treatment, not all patients are eligible for this study. Only patients with ”high-risk” smoldering myeloma are considered eligible for this study as these are all patients whose risk of developing myeloma that requires therapy is the highest.
4. E1A11: A Randomized Phase III Trial of Bortezomib, Lenalidomide & Dexamethasone vs. Carfilzomib, Lenalidomide, Dexamethasone Followed by Limited or Indefinite Duration Lenalidomide Maintenance in Patients with Newly Diagnosed Symptomatic Multiple Myeloma
The treatment of myeloma has significantly changed as a result of several drugs being introduced for its treatment such as bortezomib, carfilzomib and lenalidomide. All these drugs used with dexamethasone or in combinations that contain more than one of these drugs allow greater control of the disease process. However, we still do not fully understand the best way to combine these drugs and how long the treatment process needs to be continued in order to provide the maximum benefit to the patients. The treatment combinations that are being compared in this study are both effective, but they have different side effects, which can impact whether patients tolerate the treatment for a prolonged time.
This study has two parts, the first part is related to the initial treatment of your myeloma (also called induction) and a second part is related to continued long term control of the myeloma (also called maintenance). The purpose of the first part of the study is to compare the effects, good and/or bad, of a combination of carfilzomib, lenalidomide and dexamethasone with another combination of bortezomib, lenalidomide and dexamethasone, on you and your cancer to find out which is better. In this study, you will get either the combination that contains carfilzomib or that containing bortezomib. You will not get both. Following the initial treatment of your myeloma (induction), the second part of the study will examine if it is better to continue lenalidomide until the myeloma comes back or limit it for a defined period of 2 years. In this study, your lenalidomide will be either stopped after 2 years or you will stay on it until the myeloma relapses.
For more information on these protocols or any other research, please contact your physician or our clinical research coordinator, Jessica Gerlach, CCRP at 845-333-1133.