Cancer - Oncology

Clinical Trials

Our treatment approach emphasizes the translation of scientific discovery to clinical applications. We have a robust program of clinical trials, under the leadership of Ajai Chari, MD, that enable patients to benefit from innovative and advanced treatment options.

Clinical trials, also known as clinical research protocols, let us test new treatments in a safe, structured manner and collect data that enables statistically valid analysis. They are instrumental in advancing approval of new drugs that are beneficial to patients. Many new drugs have been approved for myeloma recently, including four in 2015 alone. Our research program has played a pivotal role in approval by the U.S. Food and Drug Administration (FDA) of many of these new drugs, including Carfilzomib, Pomalidomide, Elotuzamab, Daratumamab, and Ixazomib. We would not have been able to achieve this progress without patient participation in clinical trials.

Many questions remain about the causes of myeloma, sequencing and mechanisms of resistance to therapies, and personalization of treatment. Clinical trials can help answer these questions. We are also looking tirelessly to develop new options for patients who have exhausted currently available therapies.

Depending on the stage of your disease, exposure to prior therapies, and overall health, you may be eligible to participate in a clinical trial. Your doctor will determine whether you are a candidate for a clinical trial and are likely to benefit from it. If you are eligible for a trial, we will talk with you about the “Informed Consent” form, which describes the study and its potential benefits and safety concerns. You will have time to review this document at home, and we will answer any questions you may have as you decide if you want to participate. Some of our clinical trials are only open to patients at Mount Sinai. With our large patient volume, these “investigator-initiated” trials can enroll enough patients for statistically valid data.

We also conduct studies together with pharmaceutical companies that are developing new drugs based on our findings as well as discoveries from other laboratories. For example, we are participating in Celgene’s Chimeric Antigen Receptor (CAR)-T cell clinical trial, an innovative immunotherapy approach with promising results to date. (In this study, T-cells from myeloma patients are genetically engineered to recognize a protein known as B-cell maturation antigen (BCMA) found on malignant plasma cells. Once injected back into the patient, these altered T-cells seek out and kill BCMA-containing cells.)

In some cases, clinical trials are conducted at multiple centers (such as the CoMMpass study with the Multiple Myeloma Research Foundation). This approach enables more patients to participate and helps us more quickly gather the statistical results necessary to gain FDA approval of new drugs.