Contents:
INTRODUCTION
FREQUENTLY ASKED QUESTIONS - FOR PATIENTS
FREQUENTLY ASKED QUESTIONS - FOR PHYSICIANS
REPORTS OF BANK ON A CURE
In recent years, scientists have completely mapped the human genome (The complete set of genetic information) offering a pathway towards a better understanding of functions of human DNA. During the first decade of this century, the International Myeloma Foundation - IMF launched a comprehensive myeloma-specific DNA bank - Bank On A Cure?.
The Czech Myeloma Group take part in this project and will hopefully find a wide range of cooperative patients. We would like to thank the involved patient in advance.
At the present time, Bank on a Cure explores genetic changes that could be responsible for the risk of developing the disease, of causing progression of the disease or influencing medical response. As well as in clinical trials, the collected data must be analyzed on a large scale and neither individuals nor physicians can be provided with any specific genetic profile before the positive links and their validity are determined.
What is Bank on a Cure?
Bank on a Cure is a first comprehensive myeloma-specific DNA bank. Through the Bank on a cure initiative, the IMF helps to advance research in the field of multiple myeloma. The IMF supports this unique program to give the world a bridge to understanding human DNA and to improve treatment of multiple myeloma and bone marrow mclassancies. The primary purpose of the "bank" is to collect relevant information and DNA samples from at least 10 000 patients. This international program is scheduled for 3 years and includes 17 centres and more than 30 000 patients.
How does Bank on a Cure work?
First of all, the DNA samples are collected using a simple oral procedure called "swish & rinse" or serum or bone marrow. The sample, together with the questionnaire and the informed consent. are send to Minnesota University in USA or to Royal Marsden Hospital in England. The stored DNA samples as well as the information from questionnaire are handled confidentially in accordance with international standards for research. The DNA will be tested to determine the presence or absence of gene variants which determine:
The primary analysis will compare gene variants and outcome using a computer system.
Genetic studies, using the conclusions of the myeloma bank analyses, are going to create unique protocol establishing a new targeted treatment.
The purpose of Bank on a Cure
Every day, more than 1 000 new cases of myeloma are diagnosed worldwide. The DNA bank allows myeloma research to move to the genetic level becoming a source for progressing molecular research and for fdeveloping new cures.
Through the Bank on cure, the treatment can be selected based upon the unique genetic patterns of individual myeloma patients. Treatment side effects can be predicted. Specific drugs (chemotherapy) can be selected and drug dosages adjusted accordingly, thus optimizing effectiveness while minimizing toxic side effects. By identifying the genetic pattern of myeloma patients, strategies for early intervention and prevention can be developed.
Bank On A Cure will serve as a model for other cancerous diseases.
Project Bank on a Cure - Time Schedule
2003
Phase I:
Phase II:
A. Evaluate gene markers to predict how an individual patient will respond to Thalidomide and Velcade treatment.
B. Evaluate DNA of the patients with myeloma in family" - family where two or more members were diagnosed with multiple myeloma
Undertake an entrance sibling analysis including at least 100 families.
Determine the genes relating to a higher likelihood of myeloma incidence in a family.
2004
Phase III:
2005
Phase IV:
What is the relationship between the IMF and Bank on a Cure?
As the oldest and largest myeloma organization, the IMF is in a unique position to engage the global myeloma community to find new approaches to myeloma diagnosis and treatment. The IMF initiated the concept of Bank On A Cure through its Scientific Advisory Board and has worked with a wide range of partners including CMG to launch this important project.
Goals/Benefits for patient
How can Bank on a Cure affect treatment?
Bank On a Cure will allow researchers to determine sensitivity to specific existing and new treatments, susceptibility to toxic side effects and the contributing factors and/or a predisposition to myeloma. This knowledge may lead to new drug development and the potential for a cure.
What is DNA?
DNA is Deoxyribose Nucleic Acid, the substance for genetic information. Actually, DNA is a double-stranded helix held together by bonds between pairs of nucleotides. The combinations and permutations of the four types of nucleic acid create the diversity of all living organisms.
What is a gene?
A gene is the fundamental unit of heredity. A gene is an ordered sequence of nucleotides located in a particular position on a particular chromosome. Genes contain the information for making a specific protein or molecule performing specific functions. A mutation of a gene may cause a disorder or absence of these functions.
How can patient participate in the project?
Patient may be asked to participate in the project in Department of Internal Medicine, Haematological Oncology of University Hospital in Brno. The patients register by signing an informed consent and by filling up a questionnaire. A DNA sample is than taken (during a routine bone marrow examination).
How is DNA collected for testing?
Every cell in the body contains the same DNA. For Bank on a Cure purposes, two simple sources of collecting DNA may be used:
How will the patient DNA be used?
In the first phase of the project, the DNA is used to validate and establish the comprehensive myeloma DNA bank. In follow-up, the individual patient results will be used to determine eligibility. These trials will be designed to select the best treatment for each patient based upon the personal DNA profile.
What is the difference between Bank on a Cure and microarray analysis ?
Bank on a Cure is a project targeted at setting a unique DNA sample bank from myeloma patients. The main purpose is to provide a list of the changes of the Single Nucleotide Polymorphism (SNP) relating to the different susceptibilities to cancer, as well as sensitivity to targeted anticancer therapies and to their toxicity. The SNP analysis characterizes the myeloma patient micro-milieu on the molecular level. Unlike the SNP analysis, the microarray analysis is aimed to examine RNA not considering myeloma. Both types of obtained information are complementary. Nonetheless, the RNA samples, relevant for microarray analysis are not stable and are likely to be impaired during transportation. The instability of RNA sample prevent multicentre studies on microarray analysis to be carried out. With regard to the fact that DNA is stable and can be easily transported to the central laboratory, the project Bank on a Cure is of a great benefit for molecular clinical studies.
Why both patient and doctor involving is necessary?
The participation in the project enable patients to get access to new targeted therapy that demand molecular characteristics. This project is first of its kind and may benefit patients to get targeted therapy respecting their DNA profile. The doctors may get access to novel findings and take part in the first clinical trial evaluating genetic causes.
How will patient confidentiality be protected?
Informed consent is required for participation. This means the patient has agreed to participate and complete confidentiality will be upheld within the the valid regulation of the Law for patients´ and Ethics commission requirements.
What happens to the DNA information?
Bank On A Cure DNA information is kept confidential as part of the DNA bank. The data from the Bank will be accessible only to interested parties of this international study. Participation requirements are evaluated by the Scientific Board of Advisors and by the Ethics Commission. The members of the Scientific Board are physicians that have significant experience in myeloma treatment and in conducting extensive research projects.
Geraldine Ferraro (patient diagnosed with MM in 1998) - Bank On A Cure holds tremendous potential to move our understanding of myeloma forward by leaps and bounds," said Ms. Ferraro. "I am delighted to take part in a project that will benefit not only current myeloma patients such as myself, but also cancer patients for years to come."
Susie Novis (ThePresident of the Internationa Myeloma Fund - IMF) We foresee a time in the near future when each patient´s treatment will be tailored to his or her own genetics, allowing better, more effective therapies. This important project will move us closer to that goal and to finding a cure for myeloma."
Brian Durie, MD (Chairman of the board of the IMF) - This personalized molecular approach to myeloma research and treatment is a key component to the IMF´s research efforts to introduce molecular medicine into day-to-day myeloma management. Bank On a Cure is the world´s first databank of myeloma patient DNA and information. The project brings together the global myeloma community to create a truly collaborative research environment with the ability to analyze complex genetic information from thousands of myeloma patients around the world. Bank On a Cure has already collected DNA samples from more than 5,000 myeloma patients. Researchers are currently looking at patients´ responses to treatments to improve the benefits of existing therapy, reduce side effects, and improve patients´ quality of life right now.
