| | | | JINLAI FU | 862-579-5736 | jfu@celgene.com | I like to get data in Multiple Myeloma for analysis, hopefully In Nov. It would you great if you can get back to me at your earliest convenience. | United States | | Multiple Myeloma | All Ages | Bone Marrow, Cord Blood, Peripheral Blood | Autologous (patient's cells), Allogeneic - Related (patient's sibling or another family member's cells), Allogeneic - Unrelated (volunteer donor's cells) | | | 11/4/2015 10:03 AM | | | | |
| | | | Niels Bossers | +31 61 186 7951 | niels.bossers@quintiles.com | To whom it may concern,
Today (December 8th, 2015) I reached out to you concerning participating in our short survey (1-2 minutes) we sent out to gather more knowledge about your database “CIBMTR”.
In short, we are conducting a research to identify relevant organisations that collect real world data (RWD), and that would be interested to collaborate with a biotechnology company. By means of secondary research, we discovered that you are collecting data on multiple diseases in your database.
We would highly value your input in better understanding the type of data your organisation collects.
We would appreciate it if you could take 1-2 minutes to answer our questions related to your database.
1. Would you consider collaborating with a third party for research purposes?
2. Do you have data on patients with a hemoglobinopathy diagnosis? a. If yes, do you capture data on patients with beta-thalassemia? i. If yes, how many patients with beta-thalassemia does the database contain? b. If yes, do you capture data on patients with beta-thalassemia major/ transfusion dependent beta-thalassemia? i. If yes, how many patients with beta-thalassemia major/ transfusion dependent beta-thalassemia does the database contain?
3. Do you capture data on disease characteristics… a. Severity of the disease? (e.g. transfusion dependent, beta-thalassemia major, intermedia and minor) b. Lab parameters? (e.g. total haemoglobin levels, iron overload) c. Genetic mutations causing beta-thalassemia?
4. Do you capture data on therapy… a. Therapies and procedures? (e.g. iron chelation) b. Gene therapy? c. Blood transfusions? d. Bone marrow transplantation?
5. Do you capture data on health related outcomes… a. Mortality? b. Therapy-related adverse events? (type, start & end date, grade) c. Quality of life of patients?
6. Do you capture data on incidence of complications from living with beta-thalassemia? (e.g. liver dysfunction, cardiac dysfunction, endocrinopathies)
7. Do you capture health resource utilization?
The easiest way to participate is to directly respond to this e-mail, tick the boxes, and fill in the free text fields in the table above. We would be very grateful if you could complete and return the survey as soon as possible.
Please do not hesitate to contact us for any further questions or information.
Thank you in advance for your time and we look forward hearing from you.
Kind regards,
Niels Bossers
| Europe | | beta-thalassemia | All Ages | Bone Marrow, Peripheral Blood | Autologous (patient's cells), Allogeneic - Related (patient's sibling or another family member's cells), Allogeneic - Unrelated (volunteer donor's cells) | | | 12/8/2015 8:58 AM | | | | |
| | | | Niels Bosses | +31 61 186 7951 | niels.bossers@quintiles.com | To whom it may concern,
Today (December 8th, 2015) I reached out to you concerning participating in our short survey (1-2 minutes) we sent out to gather more knowledge about your database “CIBMTR”.
In short, we are conducting a research to identify relevant organisations that collect real world data (RWD), and that would be interested to collaborate with a biotechnology company. By means of secondary research, we discovered that you are collecting data on multiple diseases in your database.
We would highly value your input in better understanding the type of data your organisation collects.
We would appreciate it if you could take 1-2 minutes to answer our questions related to your database.
1. Would you consider collaborating with a third party for research purposes?
2. Do you have data on patients with a hemoglobinopathy diagnosis? a. If yes, do you capture data on patients with beta-thalassemia? i. If yes, how many patients with beta-thalassemia does the database contain? b. If yes, do you capture data on patients with beta-thalassemia major/ transfusion dependent beta-thalassemia? i. If yes, how many patients with beta-thalassemia major/ transfusion dependent beta-thalassemia does the database contain?
3. Do you capture data on disease characteristics… a. Severity of the disease? (e.g. transfusion dependent, beta-thalassemia major, intermedia and minor) b. Lab parameters? (e.g. total haemoglobin levels, iron overload) c. Genetic mutations causing beta-thalassemia?
4. Do you capture data on therapy… a. Therapies and procedures? (e.g. iron chelation) b. Gene therapy? c. Blood transfusions? d. Bone marrow transplantation?
5. Do you capture data on health related outcomes… a. Mortality? b. Therapy-related adverse events? (type, start & end date, grade) c. Quality of life of patients?
6. Do you capture data on incidence of complications from living with beta-thalassemia? (e.g. liver dysfunction, cardiac dysfunction, endocrinopathies)
7. Do you capture health resource utilization?
The easiest way to participate is to directly respond to this e-mail, tick the boxes, and fill in the free text fields in the table above. We would be very grateful if you could complete and return the survey as soon as possible.
Please do not hesitate to contact us for any further questions or information.
Thank you in advance for your time and we look forward hearing from you.
Kind regards,
Niels Bossers
| Europe | | Beta thalassemia | All Ages | Bone Marrow | Autologous (patient's cells), Allogeneic - Related (patient's sibling or another family member's cells), Allogeneic - Unrelated (volunteer donor's cells) | | | 12/8/2015 9:20 AM | | | | |
| | | | Ken Abreu | 609-528-5620 | ken.abreu@eusapharma.com | Seeking a listing of the latest year (2013) of available sales data, the total number of TOTAL BMTs performed in the US, ideally broken out by state and hospital within each state.
This is urgent, so please send me something as soon as possible. Thank you. | United States | | All Diseases | All Ages | Bone Marrow | Autologous (patient's cells), Allogeneic - Related (patient's sibling or another family member's cells), Allogeneic - Unrelated (volunteer donor's cells) | | | 3/1/2016 12:24 PM | | | | |
| | | | Arzu Sonmez | 12345678 | arzussonmez@gmail.com | I need this data to add my report to compare the quantites of Bone Marrow transpalntation in the US and the Europe and the other transplantation types | United States, Europe | 1/1/2015 | All Diseases | All Ages | Bone Marrow, Peripheral Blood, Cord Blood | Autologous (patient's cells), Allogeneic - Unrelated (volunteer donor's cells), Allogeneic - Related (patient's sibling or another family member's cells) | | | 6/7/2016 2:15 AM | | | | |
| | | | Megan Smith | (302)498-7476 | MSmith@Incyte.com | I am requesting access to data in support of developing a forecast model for Acute and Chronic GVHD patients for a potential new product in development for treating Acute and Chronic GVHD.
| United States | | All Diseases | All Ages | Bone Marrow | Allogeneic - Related (patient's sibling or another family member's cells), Allogeneic - Unrelated (volunteer donor's cells) | | | 6/29/2016 9:29 AM | | | | |
| | | | Mike Rauscher | 415-455-7914 | mike.rauscher@bmrn.com | We are currently considering work on a clinical development program for sickle cell disease in both adult and pediatric populations (ages 5-35 years old), using a genetically modified cell product consisting of autologous human CD34+ HSPCs transduced using a Lentiviral vector. Based on discussions with our Key Opinion Leaders, we hypothesize that the pediatric population will likely respond better to this treatment. As we are designing our Proof of Concept Phase 1 trial, we are interested in identifying an adult population that could have improved outcomes with an autologous transplant (versus allogenic transplant) most similar to the pediatric population. As such, we were hoping to get access to natural history data from the IBMTR database on autologous transplant SCD patients, with a particular focus on any possible prognostic indicators (e.e., age, disease burden/severity, transfusion dependence vs transfusion independence, types of complications, use of hydoxyurea, etc) in terms of SCD outcomes in the adult population (ages 18-35 years old). SCD outcomes to include, but not limited to: - Successful engraftment - % chimerism - Overall Survival - Incidence of trans-plant related mortality and morbidity - Frequency of vaso-occlusive crises, acute chest syndrome and ischemic events (with and without hospitalization) pre and post - RBC transfusion requirements pre and post - Pain meds use
| United States, Europe | | Sickle Cell Disease & beta-thalassemia | 5-35 years old | Bone Marrow, Peripheral Blood | Autologous (patient's cells), Allogeneic - Related (patient's sibling or another family member's cells), Allogeneic - Unrelated (volunteer donor's cells) | | | 11/29/2016 7:06 PM | | | | |
| | | | Mohammad H Forouzanfar | 4255272565 | mforouzanfar@seagen.com | We would like to know the survival and mortality rate of BMT in AML (AML&MDS) patients. Time periods for survival may be survival at 3 months, 6 months and 1 year by fine age groups (10 years groups) and subgroups including: Type of conditioning, patient’s situation at the time of BMT with regard to first time/remission/recurrence/primary refractory, type of AML (primary vs secondary and MDS). Patients with first occurrence of disease (in first CR or CR1) and conditioning intensity. Also relative survival or hazard ratio by prognostic patient characteristics such as remission/refractory and primary/secondary AML, and conditioning intensity. Also if possible, the rate of hepatotoxicity and more specifically, incidence of hyper bilirubinemia and Veno-Occlusive Disease of the Liver (Hepatic sinusoidal obstruction syndrome (SOS) by prognostic factors above. Thanks
| United States | | Acute Myeloid Leukemia, Myelodysplastic Leukemia, Acute Lymphoblastic Leukemia | All Ages | Bone Marrow, Peripheral Blood, Cord Blood | Autologous (patient's cells), Allogeneic - Related (patient's sibling or another family member's cells), Allogeneic - Unrelated (volunteer donor's cells) | | | 1/10/2017 4:12 PM | | | | |
| | | | Timothy Chanoux | 617-768-6465 | tim.chanoux@sanofi.com | I am looking to understand the frequency of which the Basal Cell Skin Malignancy, and the Squamous Cell Skin Malignancy boxes are checked on the pot-TED form. In particular, what percent of post-TED forms come back with those boxes checked. | United States | | All Diseases | All Ages | Bone Marrow | Autologous (patient's cells) | | | 3/15/2017 7:52 AM | | | | |
| | | | Robert Igarashi | 510-407-5383 | robert.igarashi@cytosen.com | We are a startup developing NK cell therapeutics for hematological oncology purposes. | United States | | Acute Myeloid Leukemia, Chronic Myeloid Leukemia | All Ages | Bone Marrow | Allogeneic - Related (patient's sibling or another family member's cells) | Overall Survival | Progression free survival, relapse rate, Chronic GVHD, Acute GVHD, Treatment-related Mortality, Relapse, Disease-free Survival, Neutrophil recovery | 3/20/2017 2:12 PM | | | | |
| | | | Sarah Goring | 778-994-5115 | sarah.goring@iconplc.com | We are interested in gaining full access to de-identified data from CIBMTR. I have several other questions and would be interested in setting up a meeting to discuss. | United States, Europe | | All Diseases | 18+ | Bone Marrow, Cord Blood, Peripheral Blood | Allogeneic - Related (patient's sibling or another family member's cells), Allogeneic - Unrelated (volunteer donor's cells) | Overall Survival | Response at day 28, Acute GVHD | 3/31/2017 12:41 PM | | | | |
| | | | Graham Osborn | 4042912972 | graham.osborn@sppirx.com | We would like to query the registry for retrospective data on GI side effects/ mucositis post-transplant for Evomela vs other versions of melphalan. | United States | | Multiple Myeloma | All Ages | Bone Marrow | Autologous (patient's cells) | | mucositis, GI side effects | 5/17/2017 9:27 AM | | | | |
| | | | Steven price | 908-642-1387 | Sprice@actiniumpharma.com | Do you have data on the patient number or percent of transplants in aml that are over 56 years of age? | United States | | Acute Myeloid Leukemia | 55 yo and older | Bone Marrow | Allogeneic - Related (patient's sibling or another family member's cells) | | | 7/13/2017 5:04 PM | | | | |
| | | | 1 | http://www.emailmeform.com/builder/form/lXbU6rMeHFZ21607WbR0 | https://eddrugs2017.tumblr.com | Erectile dysfunction (ED) occurs when a man has consistent and repeated problems sustaining an erection. Without treatment, ED can make sexual intercourse difficult. The problem is reported by 1 in 5 men and that number increases with age. Erectile dysfunction (impotence) is the inability to get and keep an erection firm enough for sex. Having erection trouble from time to time isn't necessarily a cause for concern. If erectile dysfunction is an ongoing issue, however, it can cause stress, affect your self-confidence and contribute to relationship problems. Problems getting or keeping an erection can also be a sign of an underlying health condition that needs treatment and a risk factor for heart disease. If you're concerned about erectile dysfunction, talk to your doctor — even if you're embarrassed. Sometimes, treating an underlying condition is enough to reverse erectile dysfunction. In other cases, medications or other direct treatments might be needed.
| United States | | All Diseases | All Ages | Bone Marrow | Autologous (patient's cells) | | | 7/27/2017 11:11 AM | | | | |
| | | | Dong Wei | 4155356644 | weidong3@hotmail.com | Treos Bio is a start-up biotech company, and one of our research directions is association of risks of cancer (including the specific disease and treatments such as transplant) and baseline patient data (including demographics and HLA data). We are interested in obtaining access to the following Baseline recipient data:
• Diagnosis – disease subclassification or histology, stage at transplant, pre-HCT disease treatment • Demographic –gender, age, race/ethnicity • Transplant procedure – HLA typing • Clinical – coexisting diseases
| United States, other regions OK | | All Diseases | All Ages | Bone Marrow, Peripheral Blood, Cord Blood | Autologous (patient's cells), Allogeneic - Related (patient's sibling or another family member's cells), Allogeneic - Unrelated (volunteer donor's cells) | | | 8/10/2017 1:11 PM | | | | |
| | | | Willis Navarro | 8056234246 | wnavarro@atarabio.com | We hope to understand the incidence and overall survival outcomes for patients who develop PTLD after alloHCT | United States, All CIBMTR regions | | Post-transplant lymphoproliferative disease post-alloHCT | All Ages | Bone Marrow, Cord Blood, Peripheral Blood | Allogeneic - Related (patient's sibling or another family member's cells), Allogeneic - Unrelated (volunteer donor's cells) | Overall Survival | Treatment-related Mortality, Relapse, Disease-free Survival | 9/19/2017 9:30 AM | | | | |
| | | | Shengnan Xie | 3024986173 | sxie@incyte.com | Would like to request a breakdown list of the incidence and overall survival of aGvHD and cGvHD at each state in the US. | United States | | All Diseases | All Ages | Bone Marrow, Peripheral Blood, Cord Blood | Allogeneic - Related (patient's sibling or another family member's cells), Allogeneic - Unrelated (volunteer donor's cells) | Overall Survival | Treatment-related Mortality, Relapse, Disease-free Survival, Acute GVHD, Chronic GVHD | 9/28/2017 1:50 PM | | | | |
| | | | Winifred Werther, PhD | 650.244.3710 | wwerther@amgen.com | Describe patient and clinical characteristics of the MM patients who receive ASCT in the US from 2012-2016. Characterize induction treatment regimens in MM patients undergoing ASCT by year (2012-2016). Estimate disease related outcomes by year and by induction regimens during follow-up including time to disease progression and overall survival
| United States | | Multiple Myeloma | All Ages | Bone Marrow | Autologous (patient's cells) | Overall Survival | progression free survival | 10/12/2017 12:47 PM | | | | |
| | | | Nalini Purkayastha | +16093024751 | nalini_purkayastha@bms.com | Looking for a potential data purchase to understand GVHD patient dynamics to understand company performance. | United States | | All Diseases | All Ages | Bone Marrow | Autologous (patient's cells), Allogeneic - Related (patient's sibling or another family member's cells), Allogeneic - Unrelated (volunteer donor's cells) | Overall Survival | Acute GVHD, Chronic GVHD, Treatment-related Mortality, Relapse, Disease-free Survival, Neutrophil recovery | 12/12/2017 2:17 PM | | | | |
| | | | Robert Igarashi | 510-407-5383 | robert.igarashi@cytosen.com | Development of NK cell therapies | United States | | All Diseases, Myelodysplastic Leukemia, Acute Myeloid Leukemia | All Ages | Bone Marrow | Allogeneic - Related (patient's sibling or another family member's cells), Allogeneic - Unrelated (volunteer donor's cells) | Overall Survival | CMV eactivation, Acute GVHD, Chronic GVHD, Treatment-related Mortality, Relapse, Disease-free Survival, Neutrophil recovery | 1/10/2018 5:15 PM | | | | |
| | | | Andrew Harrell | 972-415-5996 | a.harrell@lek.com | Thank you for your help. We are conducting a study and would like to understand the volume of allogeneic transplants done, by facility in the U.S., in recent years. We would be interested in understand the source of the tissue (donor type) and also the tissue type - all by hospital / center, please. | United States | | All Diseases | All Ages | Bone Marrow, Peripheral Blood, Cord Blood | Allogeneic - Related (patient's sibling or another family member's cells), Allogeneic - Unrelated (volunteer donor's cells) | Overall Survival | Acute GVHD, Chronic GVHD, Treatment-related Mortality, Relapse, Disease-free Survival, Neutrophil recovery | 1/31/2018 12:43 PM | | | | |
| | | | Kelly Cobo | 404-548-3526 | kelly.cobo@anthem.com | North American Survival Data for 2015 & 2016 separated by Autologous and Allogeneic related, and Allogeneic unrelated for both adult and pediatric. | United States | | All Diseases | All Ages, Separated by pediatric and adult | Bone Marrow, Cord Blood, Peripheral Blood | Autologous (patient's cells), Allogeneic - Related (patient's sibling or another family member's cells), Allogeneic - Unrelated (volunteer donor's cells) | | | 2/7/2018 12:50 PM | | | | |
| | | | Kelly Cobo | 4045483526 | kelly.cobo@anthem.com | Report of North American US Data for Autologous, Allogeneic Related and Allogeneic Unrelated for 2015 & 2016 - separated by adult and pediatric. | United States | | All Diseases | All Ages | Bone Marrow, Cord Blood, Peripheral Blood | Autologous (patient's cells), Allogeneic - Related (patient's sibling or another family member's cells), Allogeneic - Unrelated (volunteer donor's cells) | | | 2/7/2018 1:09 PM | | | | |
| | | | Sherry Fisher | na | slfisher@mcw.edu | I am testing this page as we've received reports of external users receiving an error when attempting to submit a request this way. | United States | | All Diseases | All Ages | Bone Marrow | Autologous (patient's cells) | | | 4/18/2018 11:29 AM | | | | |
| | | | Test - Joshua Gier | 9206272346 | jjgier@live.com | This is a test description | United States | 1/1/2010 | All Diseases | All Ages | Bone Marrow | Autologous (patient's cells) | | | 4/19/2018 12:58 PM | | | | |
| | | | James Neels | 609-454-7945 | jneels1@its.jnj.com | Looking to understand the treatment characteristics for multiple myeloma patients who receive a stem cell transplant. We would like to understand the pricing implications of various outcomes requested, disease states and history. | United States | | Multiple Myeloma | All Ages | Bone Marrow, Peripheral Blood, Cord Blood | Autologous (patient's cells), Allogeneic - Related (patient's sibling or another family member's cells), Allogeneic - Unrelated (volunteer donor's cells) | Overall Survival | Acute GVHD, Chronic GVHD, Treatment-related Mortality, Relapse, Disease-free Survival, Neutrophil recovery, Interested in effectiveness of certain therapies and depth of response | 5/2/2018 9:29 AM | | | | |
| | | | Nalini Purkayastha | +16093024751 | nalini_purkayastha@bms.com | The purpose of this request is to accurately forecast the potential product manufacturing requirement should we get the indication we are applying for with the FDA. | United States | | All Diseases, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Leukemia, Chronic Myeloid Leukemia, Non-Hodgkin Lymphoma, Multiple Myeloma | All Ages | Bone Marrow, Cord Blood, Peripheral Blood | Autologous (patient's cells), Allogeneic - Related (patient's sibling or another family member's cells), Allogeneic - Unrelated (volunteer donor's cells) | | Acute GVHD, Treatment-related Mortality, Relapse, Disease-free Survival, Chronic GVHD, Neutrophil recovery | 5/7/2018 12:26 PM | | | | |
| | | | Andrew Dietz | 6127191200 | adietz@bluebirdbio.com | Beta-thalassemia allo-HSCT outcomes | United States | | Beta-Thalassemia | All Ages | Bone Marrow, Peripheral Blood, Cord Blood | Allogeneic - Related (patient's sibling or another family member's cells), Allogeneic - Unrelated (volunteer donor's cells) | Overall Survival | Acute GVHD, Chronic GVHD, Neutrophil recovery, Treatment-related Mortality, Relapse, Disease-free Survival, If possible, rejection free, chronic GVHD free survival | 5/7/2018 2:54 PM | | | | |
| | | | Stephen Carpenter | 917-703-8206 | stephen.carpenter@regeneron.com | We are planning an early phase trial in recipients of both matched unrelated donor, and HLA-mismatched (but not haploidentical) stem cell transplant recipients, and are interested in matching our cases to appropriately to patients in the CIBMTR database, and looking at engraftment rates, overall survival, infection, timing and rates of acute GVHD (Grades2-4 and 3-4), timing and rates of chronic GVHD, disease-free survival, relapse rate, immunosuppression-free survival. We would like to match controls from the database to patients in our trial based on age, diagnosis, immunosuppression, and type of graft. We welcome a discussion with the CIBMTR and your statistics groups to assist us with the best trial strategy / matching strategy. | United States | | All Diseases | 12 and older | Bone Marrow, Peripheral Blood | Allogeneic - Unrelated (volunteer donor's cells) | Overall Survival | | 5/11/2018 2:52 PM | | | | |
| | | | Sean E. Connolly | 609-302-3315 | sean.connolly@bms.com | Request for patient level dataset used in Leslie Kean's protocol CIBMTR SC16-04c. Data will be combined into a single SDTM data set and a single ADAM data set for Study GVH1201. Combined Datasets will be used in FDA submission | United States | | All Diseases | All Ages | Bone Marrow | Allogeneic - Unrelated (volunteer donor's cells) | | as described in CIBMTR SC16-04c | 6/7/2018 2:00 PM | | | | |