Smoldering Myeloma Trial: Recruiting Patients For Drug Aimed At Training Immune System To Attack Myeloma Cells

Currently, an investigational (not yet FDA approved) cancer vaccine is being evaluated in a phase 1b/2a clinical trial for the treatment of patients with moderate and high risk smoldering multiple myeloma (SMM), an asymptomatic precursor disease to Multiple Myeloma (MM). The vaccine, PVX-410 (OncoPep, Inc.), is being evaluated in the US at five cancer research hospitals. PVX-410 is comprised of four protein fragments, or peptides from proteins which are commonly found on Multiple Myeloma cells. The vaccine is designed to use these peptides to train the patient’s immune system to attack MM cells. The main purpose of this research study is to test the safety of PVX-410. This includes trying to find out the side effects of PVX-410 as well as studying the body’s immune response and effect on sMM to the vaccine alone and in combination with another drug, Revlimid® (lenalidomide, Celgene Corp.). Background Multiple myeloma (MM) is a cancer of the plasma cells whereby cancerous cells accumulate in the bone marrow and affect normal blood cell production. Although treatment strategies have improved in recent years, there is still no cure for MM. Because of this, doctors are specifically interested in methods that may delay or prevent the progression of precursor illnesses into full-blown MM. One characteristic biomarker of MM is the presence of M proteins (monoclonal) in the blood, along with other symptoms that may include anemia, hypercalcemia, bone lesions, or kidney failure. When M proteins are detected in the blood without the presence of the other symptoms, one of two precursor illnesses is said to be present. One, called monoclonal gammopathy of undetermined significance (MGUS) has a lower risk of progression to MM in comparison to the other precursor illness, smoldering multiple myeloma (SMM). According to research, high-risk SMM typically progresses to multiple myeloma in less than two years. Researchers now hope that early detection of the precursor illnesses and their re-classification based on potential of progression may lead to the delay and prevention of MM. The Details On Participating In the Clinical Trial Who can participate? To pre-qualify, patients must: have an SMM diagnosis, be HLA A2 positive, and have at least two of the following risk factors: 1) Levels of Serum monoclonal (M)-protein ≥3 g/dL 2) BMPC >10% 3) Abnormal serum free light chain (FLC) ratio (note: complete study information can be found at www.clinicaltrials.gov/show/NCT01718899 ) How will the trial and treatment affect my daily work and lifestyle? You will be expected to go to the study center for screening procedures to see if you meet the eligibility criteria. More than one visit for screening procedures will be required. If you meet the eligibility criteria, you will be expected to go to the study center for treatment and follow up visits according to the study schedule. This includes bi-weekly visits to the treatment center over the 10 weeks of study treatment and follow up visits at 1, 2, 3, 6, 9 and 12 months. What does treatment look like? If the patient meets the study criteria, they will then be required to go to the study center to receive the study drug for six injections given every two weeks over a 10 week period. Patients receive the injection and are then observed for one hour before going home. Study participants will also be given three cycles of Revlimid ® (lenalidomide) to be taken within the 10 week treatment period. The lenalidomide is taken as an orally dosed capsule. Where is the trial taking place? Currently, there are five participating US study centers: in Boston-- Dana Farber Cancer Center, Massachusetts General Hospital, and Beth Israel Deaconess Hospital; Atlanta's Emory Winship Cancer Center, and Houston's MD Anderson Cancer Center. If I live far from the site, will travel costs be covered? Study participants can be compensated for pre-approved travel expenses up to a certain amount. Study participants should discuss the compensation details with the site study coordinator. What are the potential side effects of the treatments and medications I will be receiving? All potential side effects and other treatment-specific information will be reviewed with study participants prior to enrolling in the trial by the study investigator and his/her staff. Will my insurance cover the treatment? OncoPep, the sponsor of this trial, is providing the study vaccine and Revlimid ® (lenalidomide) free of charge to study participants. You or your insurance company will be charged for portions of your care during this research study that are considered standard care. You may be responsible for co-payments and deductibles that are typical for your insurance coverage. You should contact your insurance company directly with any questions about your coverage. What if I begin the trial and decide later on that it’s not for me? Patients are allowed to withdraw from the study at any time, for any reason. How do I learn more about participating in the trial? Those interested in participating may contact any of the sites on the list and speak to the study coordinator or physician. Or call Doris Peterkin, OncoPep (e-mail: dpeterkin@oncopep.com or Tel: 978-837-1129) to learn more. About OncoPep OncoPep is developing targeted immunotherapeutics to prevent the progression of cancer, prolong survival and restore the quality of life of patients. OncoPep’s lead program is a multi-peptide therapeutic vaccine for use in treating smoldering multiple myeloma (www.oncopep.com). Sources American Cancer Society National Institutes of Health, Clinical Trials