Kathy has more than two decades of experience in the pharmaceutical industry, previously holding senior positions at G. Searle and Merck. Since founding the MMRF in , Kathy has become a widely respected leader in establishing innovative, collaborative research models in the areas of tissue banking, genomics, and clinical trials. These models are dramatically accelerating the pace at which lifesaving treatments are brought to patients and are building an end-to-end solution in precision medicine.
Today, she is recognized as a pioneer of precision medicine, a champion of data sharing, and a strong advocate for patient engagement. Under her leadership, the HBS Kraft Precision Medicine Accelerator convenes best-in-class leaders from science, business, and technology to identify and solve challenges slowing the advancement of precision medicine. The HBS Kraft PM Accelerator disseminates best practices and models to overcome these challenges, and ultimately enables faster adoption of high-impact innovations.
Learn more about Kathy. Sinai Tisch Cancer Institute. First, they are investigating immunologic therapies with a focus on using cutting edge genomic and immunologic assays to map the interaction between myeloma and the immune system in the tumor microenvironment.
These projects illuminate the mechanisms of action of novel immune therapies in both laboratory models and clinical trials and will inform the design of rational combinations. This program has a special focus on immunologic therapy in the setting of autologous stem cell transplantation for myeloma. Second, Dr. They demonstrated that type I MAGE plays a critical role in conferring resistance to chemotherapy and inhibition of apoptosis in myeloma cells through regulation of Bcl-2 family proteins and the tumor suppressor p She decided to pursue the treatment plan that had a more holistic approach, and if it came to a point in which she needed a transplant, she wanted to pick the environment that felt the most nurturing.
Randi knew that there were many steps and lifestyle changes that she had to make towards her healing. Her diagnosis affected her in medicinal, environmental, holistic, mental, personal and spiritual ways.
She continues to maintain her super healthy lifestyle and practices good dietary habits. It was difficult for Randi to believe that she had cancer, as she had to learn to recreate herself and was grateful to be alive. Randi is very active in the multiple myeloma community and participates in races all over the country. She told her doctors that she was willing to do her homework to propose to them ways in which she could slowly return to participating to a certain degree in some of her active hobbies and most importantly, she has learned to listen to her body.
I was diagnosed with multiple myeloma seven years ago at the age of It started with pain in my hip that was quickly diagnosed as cancer. This time period can be filled with uncertainty, but the thing that has always helped, whether it was the day of the diagnosis or currently, is the importance of having people in your life that are there for you. I was diagnosed with Multiple Myeloma when I was 26 years old.
I was a bit lost at first because I was very young when I received this diagnosis, but I soon realized that everyone experiences it differently. I am very motivated to share my experiences with others battling this disease and hope to empower other patients during their journey. I have been married for 35 years, with two grown sons ages 29 and 26 and am fortunate to have a very strong support system. I feel that the biggest challenge is adapting to a label of being a cancer patient.
I stay positive with all the things I am able to do and love such as cooking, painting, drawing, snow skiing and cycling. Craig C. Patti has smoldering myeloma and had no signs or symptoms of her disease when she was diagnosed. During her annual physical her bloodwork came back abnormal, so her physician ordered further testing. Patti is now in a study where some of the smoldering patients receive Revlimid for treatment and the remaining patients remain under observation without treatment.
The test is to see if the medication will help eradicate the smoldering Multiple Myeloma. As a result of the study, Patti now gets blood tests every month and every year she will get a PET scan and bone biopsy to keep an eye on the status of her Multiple Myeloma. In , Tricia was dealing with extreme fatigue. Her primary care physician ordered routine bloodwork and found that she was severely anemic.
She was then sent to a local hematologist who did a bone marrow biopsy. At this time she was diagnosed with smoldering myeloma after receiving a second opinion. Tricia participates in MMRF events in hopes of furthering multiple myeloma research. She enjoys sharing her personal experience with other myeloma patients and is looking forward to helping others understand this disease better and find resources for them that will help with their personal myeloma journey.
My husband, JP, was diagnosed with multiple myeloma six years ago at the age of We do whatever we can to support the MMRF and to keep a positive mindset about our situation. It has been a journey from day one, but I feel we are confident going forward.
It revealed that she had low platelets and was anemic. At the time, Carmen was diagnosed with smoldering multiple myeloma, as she did not meet the criteria to be diagnosed with active multiple. Carmen strives to stay positive and maintain a healthy and active lifestyle. She has persevered and embraces the changes that her diagnosis has caused in her life. His healthcare team embraced his determination to educate himself, which gave him additional confidence in his doctors.
Andrew has kept a positive outlook and is self-motivating. One motivating factor he had was retirement; although, he only wanted to semi-retire. He remains an active grandfather to his two young grandsons and helps his daughter by babysitting them. He feels that his multiple myeloma journey has made him a better person in that he is more compassionate and understanding.
Jessie is determined to not let her diagnosis define her and dominate her life; therefore, she has taken control of the situation by continuing her research and education on her diagnosis and learning the importance of practicing self-awareness and self-advocacy for her own health.
She has become dedicated in her efforts to incorporate being health-conscious in her lifestyle. Now, she's revisiting this and learning how to reinvent herself and the lifestyle she plans to lead. Jeffery stresses the importance of staying motivated and positive. He manages his lifestyle and nutrition to do what he can to have a full and active life. He is determined to continue his active hobbies.
Before and after his diagnosis, he has continued to participate in his hobbies as a marathon runner, hunter, fisherman, and hiker. He climbed Mt. Kilimanjaro earlier this year and is taking a summer vacation with his wife to Montana to backpack and hike. Doing the things he loves helps him feel empowered against his disease.
He also has found strength in becoming an active member of the multiple myeloma community. Jeffery has been extensively involved in the "mother ship" of MMRF. Jeffery is passionate about raising awareness of MMRF and helping others navigate their way and to find their path.
In addition, he is responsible for all the MMRF preclinical and translational activities. Auclair was selected by PharmaVoice in as one of the Most Inspiring People in the life-sciences industry. He also worked at the Broad Institute of MIT and Harvard where as a senior manager in the Cancer Program he was involved in a wide range of academic and industry collaborations centered around cancer genomics and precision medicine initiatives. Michael brings nearly 15 years of strategic consulting and operational experience in the life sciences industry.
Michael earned a B. Giusti worked as a Chief Executive Officer, leader, executive and entrepreneur for over 30 years; he has founded, managed and led a variety of businesses.
Early in his career, Mr. Giusti worked as an executive for GE where he held a number of management positions with a wide range of responsibilities. Giusti has worked closely with the MMRF since its founding in Donec ullamcorper nulla non metus auctor fringilla.
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Morbi leo risus, porta ac consectetur ac, vestibulum at eros. Nicole has been a registered nurse for five years, specializing in oncology and palliative care.
She began her career as an inpatient oncology nurse at Yale providing bedside care to patients and then transitioned to Norwalk Hospital where she worked as a chemotherapy infusion nurse. She received her nursing degree from Fairfield University and is currently pursuing her doctorate in nursing practice DNP. David has played an integral role in launching, building and operating several successful companies in the life sciences.
In , he, along with Robert S. Langer at the Massachusetts Institute of Technology and other co-founders, started Frequency Therapeutics with the goal of developing regenerative medicines based on discoveries related to activating progenitor cells. Prior to that, David co-founded, also with Dr. Langer, Semprus BioSciences. Semprus was acquired in by Teleflex, Inc. Prior to Semprus, David worked at the investment firm Polaris Partners.
He also serves as a trustee of Mt. David earned a B. Sloan Fellow. In , he joined Edward D. In , he left to enter the relatively new discount brokerage industry by starting Scottrade. Over the years, Scottrade evolved into an online brokerage and bank supporting its 3 million clients through branch offices nationwide. In the fall of , Rodger was diagnosed with multiple myeloma and in late , Scottrade was sold to TD Ameritrade.
In , Mr. Riney started Lightchain Capital LLC, with a focus on various capabilities investing in early-stage biotech technologies with an emphasis on therapeutics for blood cancer and multiple myeloma. Michael started his career in private practice representing many artists, producers and writers before joining the corporate ranks. He has been a contributing editor to the Practicing Law Institute volumes on the same subject and continues to lecture at various schools and seminars around the country.
He currently serves as the Chairman of the Entertainment Law Initiative of the Grammy Foundation, a division of the National Academy of Recording Arts and Sciences, which focuses on legal education programs for aspiring entertainment attorneys. He lives in Manhattan with his wife of 30 years, Karen. They have a daughter and two beautiful grandchildren.
Marie E. Pinizzotto, M. Ammon Foundation, a foundation focused on health care and education. Prior to running the foundation, she was president of Drug Safety Solutions, L.
Prior to starting her own company she worked at Endo Pharmaceuticals Inc. In this role she was responsible for pharmacovigilance of all Endo products, marketed and investigational. Marie was also responsible for the safety components in the following disciplines; Clinical Research, Medical Affairs and Clinical Education and Development. Pinizzotto received her B. She completed her residency at The Medical Center of Delaware, where she practiced obstetrics and gynecology for nine years.
She still maintains privileges at the hospital. Most recently, Dr. Currently, Dr. In addition, she is a board member at Eisenhower Medical Center, Rancho Mirage, California, and also sits on the quality improvement committee. Marie is named Chair, The Marie E. Pinizzotto is a director of The Carol A. From until , Dr. Parkinson served as President and CEO of Nodality, a South San Francisco-based venture-financed biotechnology company developing technologies to enable personalized medicine and more efficient drug development in cancer and autoimmune diseases.
Before joining Nodality, Dr. During his tenures at Amgen and Novartis, Dr. He received his M. For more information, see Medicines under additional monitoring. Multiple myeloma Revlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.
Revlimid as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone see section 4. Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.
Myelodysplastic syndromes. Revlimid as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediaterisk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.
Mantle cell lymphoma. Revlimid as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. Follicular lymphoma Revlimid in combination with rituximab anti-CD20 antibody is indicated for the treatment of adult patients with previously treated follicular lymphoma Grade 1 — 3a.
This product is no longer an orphan medicine. It was originally designated an orphan medicine for the following orphan indications :. Revlimid was withdrawn from the Community register of orphan medicinal products in 12 December upon request of the marketing authorisation holder at the time of the granting of a change to the terms of the marketing authorisation.
Please do not include any personal data , such as your name or contact details. Skip to main content. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Revlimid RSS. Table of contents Overview Authorisation details Product information Assessment history. It is used in combination with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone; in adults whose disease has been treated at least once.
It is used in combination with dexamethasone. Expand section Collapse section. Multiple myeloma Revlimid was more effective than placebo a dummy treatment in two main studies in 1, patients with newly diagnosed multiple myeloma and who had had stem cell transplantation. Myelodysplastic syndromes Two main studies have also been carried out involving a total of patients with lower risk myelodysplastic syndromes.
Mantle cell lymphoma One main study involved patients with mantle cell lymphoma that had come back after previous treatment or had not improved on previous treatment.
Follicular lymphoma The main study involved patients with slow-growing blood cancers marginal zone lymphoma or follicular lymphoma that had come back or not improved after previous treatment: of them had follicular lymphoma. Authorisation details. Product details Name Revlimid. Product information. List item. You are therefore advised to be selective about which sections or pages you wish to print.
Myelodysplastic syndromes Revlimid as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediaterisk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. Mantle cell lymphoma Revlimid as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
Assessment history. Changes since initial authorisation of medicine List item. Initial marketing-authorisation documents List item. Celgene Europe Limited withdraws its application for an extension of the indication for Revlimid lenalidomide. An increase in new second cancers has happened in patients who received REVLIMID and melphalan, or a blood stem cell transplant, including certain blood cancers, such as acute myelogenous leukemia AML , myelodysplastic syndromes MDS , and certain other types of cancers of the skin and other organs.
Severe liver problems, including liver failure and death. Tell your healthcare provider right away if you develop any of the following symptoms of liver problems: yellowing of your skin or the white part of your eyes jaundice dark or brown tea-colored urine pain on the upper right side of your stomach area abdomen bleeding or bruising more easily than normal feeling very tired Severe skin reactions and severe allergic reactions can happen with REVLIMID and may cause death.
Call your healthcare provider right away if you develop any of the following signs or symptoms during treatment with REVLIMID: a red, itchy, skin rash peeling of your skin or blisters severe itching fever Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with REVLIMID: swelling of your lips, mouth, tongue, or throat trouble breathing or swallowing raised red areas on your skin hives a very fast heartbeat you feel dizzy or faint Tumor lysis syndrome TLS.
TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS. Worsening of your tumor tumor flare reaction. Tell your healthcare provider if you get any of these symptoms of tumor flare reaction while taking REVLIMID: tender, swollen lymph nodes; low-grade fever, pain, or rash.
Thyroid problems. Risk of early death in MCL. Talk with your healthcare provider about any concerns and possible risk factors. OK Cancel. I am a patient or caregiver I am a healthcare professional.
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