Cancer Research Group Version Date: June 22, 2016 NCI Update Date: November 13, Schema
|
|
- Simon McKinney
- 5 years ago
- Views:
Transcription
1 ev. 5/14 Cancer esearch Group Schema NDUCTON 1, 3 rm Step 0 P E - E G S T T O Step 1 N D O M Z T O Stratification: ntent to stem cell transplant at progression: Yes or No Bortezomib 1.3 mg/m2 SQ or V days 1, 4, 8, 11 Cycles mg/m2 SQ or V days 1 and 8 Cycles 9-12 Lenalidomide 25 mg PO daily days Dexamethasone 20 mg PO days 1, 2, 4, 5, 8, 9, 11, 12 Cycles mg PO days 1, 2, 4, 5, 8, 9, 11, 12 Cycles mg PO days 1, 2, 8 and 9 Cycles 9-12 epeat cycles every 3 weeks for a total of 12 cycles NDUCTON rm B 1, 3 Carfilzomib 20 mg/m2 V days 1, 2; 36 mg/m2 days 8, 9, 15, 16 Cycle 1 36 mg/m2 V days 1, 2, 8, 9, 15, 16 Cycles 2-9 Step 2 Lenalidomide 25 mg PO daily days O N D O M Stratification: MNTENNCE 1,3 rm C Lenalidomide 15 mg PO daily days epeat cycles every 4 weeks for a total of 24 cycles nduction arm: Vd (rm ) or Cd (rm B) Z MNTENNCE 1,3 rm D Lenalidomide T 15 mg PO daily days epeat cycles every 4 weeks until progression or excessive toxicity Observation Until disease progression N 5 N Dexamethasone 40 mg PO days 1, 8, 15, 22 Cycles mg PO days 1, 8, 15, 22 Cycles 5-9 N epeat cycles every 4 weeks for a total of 9 cycles ccrual Goal: 756 patients with newly diagnosed, standard risk myeloma (see section for definition of standard risk) 1. Patients can mobilize stem cells any time following 4 cycles (rm ) or 3 cycles (rm B) of induction therapy. f stem cells are harvested, interruption of treatment cycles for up to 35 days is allowed for completion of stem cell collection. While stem cell collection is strongly encouraged for transplant eligible patients, it is not required for protocol participation. ev. 5/14 2. n patients with creatinine clearance of ml/min, starting dose of lenalidomide should be reduced to 10 mg. f the clearance improves to = 60 ml/min, the dose can be increased to 25 mg provided the patient has not experienced any of the toxicities that would require a dose reduction for lenalidomide. 3. t discretion of enrolling MD if considered appropriate, patients randomized to rm (Vd) can receive bortezomib injections under care of a local oncologist, returning to the enrolling institution only at the beginning of each cycle. Patients randomized to rm B (Cd) are required to receive Carfilzomib injections at the enrolling institution. During maintenance and observation (rms C and D), patients will have to be seen at the enrolling institution once every three months. 4. n patients with creatinine clearance of ml/min, starting dose of lenalidomide should be reduced to 10 mg. f the clearance improves to = 60 ml/min, the dose can be increased to 15 mg provided the patient has not experienced any of the toxicities that would require a dose reduction for lenalidomide. 5. Submission of pre-study specimens per patient consent. 7
2 Cancer esearch Group ev. 5/14 3. Selection of Patients Each of the criteria in the checklist that follows must be met in order for a patient to be considered eligible for this study. Use the checklist to confirm a patient s eligibility. For each patient, this checklist must be photocopied, completed and maintained in the patient s chart. n calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday four weeks later would be considered Day 28. Patient No. Patient s nitials (L, F) Physician Signature and Date NOTE: ll questions regarding eligibility should be directed to the study chair or study chair liaison. NOTE: nstitutions may use the eligibility checklist as source documentation if it has been reviewed, signed, and dated prior to registration/randomization by the treating physician. NOTE: This study involves pre-registration (see Section 4). Bone marrow and peripheral blood specimens are to be submitted for defined laboratory research studies and future undefined research studies as outlined in Section 10 per patient consent. 3.1 Step 1 andom ization ge 18 years Patients must be diagnosed with symptomatic standard-risk multiple myeloma (S-MM) within 90 days prior to registration as defined by all of the following (except GEP70 status if unknown): ev. 9/14, 9/15 No evidence of t(14;16) by FSH testing on bone marrow or not available: please circle: yes or no or N date of test No evidence of t(14:20) by FSH testing on bone marrow or not available: please circle: yes or no or N date of test No evidence of deletion 17p by FSH testing on bone marrow; please circle yes or no date of test NOTE: f the FSH result states that no gh abnormality is present, both t(14;16) and t(14;20) can be considered negative. n addition, if the patient has a t(11;14) or t(4;14) translocation present, they can be considered negative for t(14;16) and t(14;20). f testing for t(14;16) or t(14;20) could not be performed for lack of sufficient material or non-availability of the probe in the test panel, patients can be enrolled on the study. 19
3 Cancer esearch Group Standard isk GEP70 signature within the past 90 days (only if GEP has been done and results are available. NOTE: GEP testing is NOT a requirement for the study). f the test has been done, patients found to have a GEP70 status of High-isk will not be eligible. GEP70 Test Done? Yes No (skip remainder) GEP70 Status Standard-isk? Yes No Serum LDH 2 x ULN within the past 28 days Serum LDH: (U/L) ULN (U/L) No more than 20% circulating plasma cells on WBC differential or 2,000 plasma cells/microliter of peripheral blood within the past 90 days Plasma cell %: Plasma cells: (/microl) Patients must have measurable or evaluable disease as defined by having one or more of the following, obtained within 28 days prior to randomization: 1g/dL monoclonal protein (M-protein) on serum protein electrophoresis 200 mg/24 hrs of monoclonal protein on a 24 hour urine protein electrophoresis nvolved free light chain 10 mg/dl or 100 g/l ND abnormal serum immunoglobulin kappa to lambda free light chain ratio (< 0.26 or > 1.65) Monoclonal bone marrow plasmacytosis 30% (evaluable disease) SPEP, UPEP, serum FLC assay and bone marrow biopsy and or aspirate are required to be performed within 28 days prior to randomization. Serum M-protein by SPEP (g/dl) Urine M-protein measurement by 24 hr UPEP (mg/24hr) NOTE: UPEP (on a 24-hour collection) is required, no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is 200 mg/24 hr. Please note that if both serum and urine M-components are present, both must be followed in order to evaluate response. Serum Free Light Chain ssay Kappa FLC (mg/dl) or (mg/l); 20
4 ev. 2/15 Cancer esearch Group Lambda FLC (mg/dl) or (mg/l); kappa/lambda ratio NOTE: The serum free light chain test is required to be done if the patient does not have measurable disease in the serum or urine. Measurable disease in the serum is defined as having a serum M-spike 1 g/dl. Measurable disease in the urine is defined as having a urine M-spike 200mg/24 hr. Plasma cell % on Bone Marrow % The following laboratory levels must be obtained within 28 days prior to randomization: Hemoglobin 8 g/dl. Hemoglobin: Untransfused platelet count 75,000 cells/mm 3. Platelet: bsolute neutrophil count 1000 cells/mm 3. NC: Calculated creatinine clearance 30 ml/min Creatinine clearance: Bilirubin 1.5 mg/dl. Bilirubin: SGPT (LT) and SGOT (ST) < 2.5 times the upper limit of normal. SGPT (LT): SGOT (ST): nstitutional ULN: nstitutional ULN: Patients must have received no more than one cycle (4 weeks or less) of prior chemotherapy and no more than 160mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic myeloma. They should not have been exposed to lenalidomide, bortezomib or carfilzomib for treatment of symptomatic myeloma. Prior radiation therapy to symptomatic lesions is allowed provided 14 days is allowed between the completion of radiation therapy and start of protocol treatment Prior systemic glucocorticoid use for the treatment of non-malignant disorders is permitted. Prior or concurrent topical or localized glucocorticoid therapy to treat non-malignant comorbid disorders is permitted. 21
5 Cancer esearch Group NOTE: Concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day Patients must not have active, uncontrolled seizure disorder. Patients must have had no seizures in the last 6 months Patients must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson Syndrome ECOG performance status 0, 1, or 2. (PS 3 allowed if secondary to pain) Patients with monoclonal gammopathy of undetermined significance or asymptomatic multiple myeloma are not eligible Patients must not have Grade 2 or higher peripheral neuropathy by CTCE Patients must not have active, uncontrolled infection Patients may have a history of current or previous deep vein thrombosis or pulmonary embolism but must be willing to take some form of anti-coagulation as prophylaxis if they are not currently on fulldose anticoagulation Patients should not have New York Heart ssociation classification or V heart failure or myocardial infarction within the previous 6 months Patients with a history of prior malignancy are eligible provided they were treated with curative intent and do not require active therapy (currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast are not excluded) Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mu/ml within days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method T THE SME TME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. ll patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See ppendix V: isks of Fetal Exposure, Pregnancy Testing Guidelines and cceptable Birth Control Methods. Female of childbearing potential (Y/N)? 22
6 Cancer esearch Group female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months Sexually active males must be willing to use a condom (even if they have undergone a prior vasectomy) while having intercourse, while taking lenalidomide and for 4 weeks after stopping treatment The following patients will be excluded as this study involves an agent that may have genotoxic, mutagenic and teratogenic effects Pregnant women Nursing women HV infection is not excluded. Known HV positive patients must meet the following criteria: CD4 cell count 350/mm 3 No history of DS-related illness Not currently prescribed zidovudine or stavudine Patient enrolling to this study must agree to register to the mandatory evssist program, and be willing and able to comply with the requirements of evssist. 3.2 Step 2 andom ization Patients must not have experienced progression on Step 1 induction therapy Step 2 registration must be within 28 days of completing Step 1 therapy. Date Step 1 Therapy Completed: Patients must not have received any non-protocol therapy outside of the assigned induction therapy ECOG performance status 0, 1, or 2. (PS 3 allowed if secondary to pain) ny adverse event related to Step 1 therapy must have resolved to grade 2 or less Patient must have adequate laboratory levels as follows (within 28 days prior to randomization to Step 2) Hemoglobin 8 g/dl. Hemoglobin: Platelet count 75,000 cells/mm 3. Platelet: 23
7 Cancer esearch Group bsolute neutrophil count 1000 cells/mm 3. NC: Calculated creatinine clearance 30 ml/min. Creatinine clearance: Bilirubin 1.5 mg/dl. Bilirubin: SGPT (LT) and SGOT (ST) < 2.5 times the upper limit of normal. SGPT (LT): SGOT (ST): nstitutional ULN: nstitutional ULN: Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mu/ml within days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method T THE SME TME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. ll patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See ppendix V: isks of Fetal Exposure, Pregnancy Testing Guidelines and cceptable Birth Control Methods. Female of childbearing potential (Y/N)? female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months. 24
8 Cancer esearch Group Sexually active males must be willing to use a condom (even if they have undergone a prior vasectomy) while having intercourse, while taking lenalidomide and for 4 weeks after stopping treatment The following patients will be excluded as this study involves an agent that may have genotoxic, mutagenic and teratogenic effects Pregnant women Nursing women Patient enrolling to this study must agree to register to the mandatory evssist program and be willing and able to comply with the requirements of evssist. 25
MM relaps efter min. 3 linie behandlinger.
Inklusionskriterier: Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject is 18 years of age at the time of signing the informed consent form (ICF). 2. Subject must understand
More informationCancer Research Group Version Date: November 5, 2015 NCI Update Date: January 15, Schema. L O Step 1 1,2
Cancer esearch roup ev. 6/14, 2/15, 1/16 Step 2 Schema 5 Arm A: (7 weeks) Step 1 1,2 N Accrual: 515 S Arm S ransoral esection dissections S A N D M Z 4 ntermediate isk 7 Stratify: = 10 pk-yr vs. > 10 pk-yr
More informationAquila Smoldering Multiple Myeloma
Inklusionskriterier: Ja Nej 1. At least 18 years of age or at least the legal age of consent in the jurisdiction in which the study is taking place, whichever is the older age. 2. Diagnosis of SMM for
More informationAlliance A Symptomatic brain radionecrosis after receiving radiosurgery for
RANDOMIZED PHASE II STUDY: CORTICOSTEROIDS + BEVACIZUMAB VS. CORTICOSTEROIDS + PLACEBO (BEST) FOR RADIONECROSIS AFTER RADIOSURGERY FOR BRAIN METASTASES Pre-registration Eligibility Criteria Required Initial
More informationFigure 1: PALLAS Study Schema. Endocrine adjuvant therapy may have started before randomization and be ongoing at that time.
Figure 1: PALLAS Study Schema Endocrine adjuvant therapy may have started before randomization and be ongoing at that time. Approximately 4600 patients from approximately 500 global sites will be randomized
More informationRandomized Phase II Study of Irinotecan and Cetuximab with or without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer
Randomized Phase II Study of Irinotecan and Cetuximab with or without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer This is a two-arm, randomized phase II trial for patients with BRAF mutant
More informationProtocol Abstract and Schema
Protocol Abstract and Schema A Molecular Biology and Phase II Study of Imetelstat (GRN163L) in Children with Recurrent High-Grade Glioma, Ependymoma, Medulloblastoma/Primitive Neuroectodermal Tumor and
More informationDESIGN DE L ETUDE Environ 406 patients seront randomisés dans l un des 3 bras de l étude selon le schéma cidessous
AN OPEN-LABEL, RANDOMIZED PHASE 3 TRIAL OF COMBINATIONS OF NIVOLUMAB, ELOTUZUMAB, POMALIDOMIDE AND DEXAMETHASONE IN RELAPSED AND REFRACTORY MULTIPLE MYELOMA ETUDE CA209-602 Sponsor: BMS CONTACTS AUX HUG
More informationLow-dose AZA, Pioglitazone, ATRA Versus Standard-dose AZA in Patients >=60 Years With Refractory AML (AML-ViVA)
We updated the design of this site on December 18, 2017. Learn more. Find Studies About Studies Submit Studies Resources About Site Trial record 1 of 1 for: AMLSG26-16/AML-ViVA Previous Study Return to
More informationPOMALYST (pomalidomide) for Previously Treated Multiple Myeloma
POMALYST (pomalidomide) for Previously Treated What is POMALYST? POMALYST (pomalidomide) capsule is an oral immunomodulatory therapy (a thalidomide analogue) indicated for patients with multiple myeloma
More informationProtocol Abstract and Schema
Protocol Abstract and Schema A Phase I Trial of p28 (NSC745104), a Non-HDM2 mediated peptide inhibitor of p53 ubiquitination in pediatric patients with recurrent or progressive CNS tumors Description and
More informationUMN request : information to be made public Page 1
Product Name Active substance Indication and conditions of use Midostaurin (PKC412) Midostaurin (PKC412) soft gelatin capsules of 25 mg Compassionate Use Program with Midostaurin for newly diagnosed FLT3
More informationPatients must have met all of the following inclusion criteria to be eligible for participation in this study.
Supplementary Appendix S1: Detailed inclusion/exclusion criteria Patients must have met all of the following inclusion criteria to be eligible for participation in this study. Inclusion Criteria 1) Willing
More informationProtocol Abstract and Schema
Protocol Abstract and Schema Phase II study of Bevacizumab plus Irinotecan (Camptosar ) in Children with Recurrent, Progressive, or Refractory Malignant Gliomas, Diffuse/Intrinsic Brain Stem Gliomas, Medulloblastomas,
More informationSubject ID: I N D # # U A * Consent Date: Day Month Year
IND Study # Eligibility Checklist Pg 1 of 15 Instructions: Check the appropriate box for each Inclusion and Exclusion Criterion below. Each criterion must be marked and all protocol criteria have to be
More informationSmoldering Myeloma: Leave them alone!
Smoldering Myeloma: Leave them alone! David H. Vesole, MD, PhD Co-Director, Myeloma Division Director, Myeloma Research John Theurer Cancer Center Hackensack University Medical Center Prevalence 1960 2002
More informationAppendix ZOOM Etude pour site internet
Appendix ZOOM Etude pour site internet Indication Traitement adjuvant pour des patients présentant une mutation germinale des gènes BRCA1/2 et un risque élevé de cancer du sein primaire HER2 négatif Title
More informationDOSING FLEXIBILITY OF REVLIMID
REVLIMID Dose Adjustments for Renal Impairment DISCOVER THE DOSING FLEXIBILITY OF REVLIMID FOR PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) REVLIMID (lenalidomide) is indicated for the treatment of patients
More informationPrimary Endpoint The primary endpoint is overall survival, measured as the time in weeks from randomization to date of death due to any cause.
CASE STUDY Randomized, Double-Blind, Phase III Trial of NES-822 plus AMO-1002 vs. AMO-1002 alone as first-line therapy in patients with advanced pancreatic cancer This is a multicenter, randomized Phase
More informationFAST FACTS Eligibility Reviewed and Verified By MD/DO/RN/LPN/CRA Date MD/DO/RN/LPN/CRA Date Consent Version Dated
Page 1 of 5 COG-AEWS1221: Randomized Phase 3 Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 750008, IND# 120449) to Multiagent Chemotherapy for Patients with Newly
More informationNCCP Chemotherapy Regimen. Carfilzomib, Lenalidomide and Dexamethasone (KRd) Therapy - 28 day
, Lenalidomide and Dexamethasone (KRd) Therapy - INDICATIONS FOR USE: INDICATION ICD10 Regimen Code Reimbursement Status *, lenalidomide and dexamethasone therapy is indicated for the treatment of adult
More informationProtocol Abstract and Schema
Protocol Abstract and Schema This is a phase I/II study to determine: 1) the maximum tolerated dose (MTD) or recommended phase II dose of ABT-888 in combination with radiation therapy, and 2) the efficacy
More informationBC Cancer Protocol Summary for Therapy of Multiple Myeloma Using Carfilzomib, Lenalidomide with Dexamethasone
BC Cancer Protocol Summary for Therapy of Multiple Myeloma Using Carfilzomib, Lenalidomide with Dexamethasone Protocol Code Tumour Group Contact Physician Contact Pharmacist UMYCARLD Lymphoma, Leukemia/BMT
More informationClinical Trials in Myeloma and Related Disorders at PMH (Version: November 2017)
Clinical Trials in Myeloma and Related Disorders at PMH (Version: November 2017) NEWLY DIAGNOSED MULTIPLE MYELOMA Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance
More information* Dose may vary dependent on tolerability and co-morbidities
BC Cancer Protocol Summary for Treatment of Previously Untreated Multiple Myeloma and Not Eligible for Stem Cell Transplant Using Lenalidomide with Low-dose Dexamethasone Protocol Code Tumour Group Contact
More informationDOSING FLEXIBILITY OF REVLIMID
REVLIMID Dose Adjustments for Thrombocytopenia DISCOVER THE DOSING FLEXIBILITY OF REVLIMID FOR PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) REVLIMID (lenalidomide) is indicated for the treatment of patients
More informationSUBCUTANEOUS Bortezomib + Thalidomide +Dexamethasone Available for Routine Use in
SUBCUTANEOUS Bortezomib + Thalidomide +Dexamethasone Available for Routine Use in Burton in-patient Derby in-patient Burton day-case Derby day-case Burton community Derby community Burton out-patient Derby
More informationBC Cancer Protocol Summary for Maintenance Therapy of Multiple Myeloma Using Lenalidomide
BC Cancer Protocol Summary for Maintenance Therapy of Multiple Myeloma Using Lenalidomide Protocol Code Tumour Group Contact Physician Contact Pharmacist UMYLENMTN Lymphoma, Leukemia/BMT Dr. Kevin Song
More informationArm A: Induction Gemcitabine 1000 mg/m 2 IV once a week for 6 weeks.
ECOG-4201 (RTOG Endorsed) ECOG 4201 Pancreas (RTOG Endorsed)-1 Protocol Status: Opened: April 10, 2003 Closed: December 15, 2005 Title: A Randomized Phase III Study of Gemcitabine in Combination with Radiation
More informationSynopsis. Study Phase and Title: Study Objectives: Overall Study Design
Synopsis Study Phase and Title: Study Objectives: Overall Study Design Phase III randomized sequential open-label study to evaluate the efficacy and safety of sorafenib followed by pazopanib versus pazopanib
More informationBCCA Protocol Summary for Therapy of Multiple Myeloma Using Pomalidomide with Dexamethasone
BCCA Protocol Summary for Therapy of Multiple Myeloma Using Pomalidomide with Dexamethasone Protocol Code UMYPOMDEX Tumour Group Contact Physician Contact Pharmacist Lymphoma, Leukemia/BMT Dr. Kevin Song
More informationProtocol Abstract and Schema
Protocol Abstract and Schema A Phase 1 and Phase II Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma Description and Rationale: Low grade gliomas are among the most common primary
More informationAbstract and Schema. Phase 1 and Pharmacokinetic Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma
Abstract and Schema Phase 1 and Pharmacokinetic Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma Description and Rationale: Low grade gliomas are among the most common primary CNS
More informationNRG ONCOLOGY NRG-CC003
NRG ONCOLOGY NRG-CC003 A Randomized Phase II/III Trial of Prophylactic Cranial Irradiation with or without Hippocampal Avoidance for Small Cell Lung Cancer SCHEMA Histologic proof or unequivocal cytologic
More informationUMN request : information to be made public Page 1
Product Name Active substance Opdivo Nivolumab (BMS 936558) UMN request : information to be made public Page 1 Indication and conditions of use Nivolumab (Opdivo)) is registered by the EMA for the treatment
More informationM-Protien, what to do next? Ismail A Sharif MD, FRCPc Internal Medicine Day 22 nd April 2016
+ M-Protien, what to do next? Ismail A Sharif MD, FRCPc Internal Medicine Day 22 nd April 2016 + Disclosures Advisory Boards: AMGEN, Lundbeck, NOVARTIS + Subtypes of Plasma Cell Disorders Increased Plasma
More informationBCCA Protocol Summary for Therapy of Relapsed Multiple Myeloma Using Lenalidomide with Dexamethasone
BCCA Protocol Summary for Therapy of Relapsed Multiple Myeloma Using Lenalidomide with Dexamethasone Protocol Code Tumour Group Contact Physician Contact Pharmacist UMYLDREL Lymphoma, Leukemia/BMT Dr.
More informationKeeping track of your numbers
Keeping track of your numbers If you have relapsed or refractory multiple myeloma, keeping track of your numbers can help you take an active role in your care. It s also one way you and your doctor can
More informationPlattenepithelkarzinom des Ösophagus, 1 st -line
Plattenepithelkarzinom des Ösophagus, 1 st -line AIO-STO-0309 An open-label, randomized phase III trial of cisplatin and 5-fluorouracil with or without panitumumab for patients with nonresectable, advanced
More informationAccrual Status We are currently only enrolling patients who are either:
CC#124522 An Open-Label, Four-Part, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of the MEK Inhibitor GSK1120212, BRAF Inhibitor GSK2118436 and
More informationASCT After a Rituximab/Ibrutinib/Ara-c Containing induction in Generalized Mantle Cell Lymphoma
Find Studies About Studies Submit Studies Resources About Site Trial record 1 of 1 for: TRIANGLE AND ASCT Previous Study Return to List Next Study ASCT After a Rituximab/Ibrutinib/Ara-c Containing induction
More informationSmoldering Multiple Myeloma. A Case Study
Smoldering Multiple Myeloma A Case Study Case Presentation 53-Year-Old Male Patient presented for a routine exam No prior history of disease or family history of fhematologic disorders d or malignancies,
More informationTreatment of Relapsed. A Case Study
Treatment of Relapsed Multiple Myeloma A Case Study Case Presentation Mr. V is a 61-year-old man previously diagnosed with ISS stage III IgG λ multiple myeloma with bone lesions, normal FISH and cytogenetics,
More informationMYE FORMS REVEALED RESPONSE CODES OBJECTIVES. Stringent Complete Response (scr) Complete Response (CR) I have no conflicts of interest to disclose
I have no conflicts of interest to disclose MYE FORMS REVEALED Janet Brunner, PA-C CIBMTR MKE New10_1.ppt OBJECTIVES 1) Be able to describe the criteria required for each myeloma response code 2) Be able
More informationClinical Trials in Myeloma and Related Disorders at PMH (Version: September 2017)
Clinical Trials in Myeloma and Related Disorders at PMH (Version: September 2017) NEWLY DIAGNOSED MULTIPLE MYELOMA Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance
More informationDCLLSG Studienzentrale CLL2P Protokoll Version CLL2P protocol of the German CLL Study Group (GCLLSG)
2. Protocol Synopsis Title A phase I/II safety and efficacy trial of a combination of bendamustine, rituximab and lenalidomide (BRL) in patients with relapsed or refractory chronic lymphocytic leukemia
More informationClinical Trial Results Database Page 1
Page 1 Sponsor Novartis UK Limited Generic Drug Name Letrozole/FEM345 Therapeutic Area of Trial Localized ER and/or PgR receptor positive breast cancer Study Number CFEM345EGB07 Protocol Title This study
More informationAbstract and Schema. Phase 1 and Pharmacokinetic Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma
Abstract and Schema Phase 1 and Pharmacokinetic Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma Description and Rationale: Low grade gliomas are among the most common primary CNS
More informationVelcade (bortezomib)
Velcade (bortezomib) Line(s) of Business: HMO; PPO; QUEST Integration Akamai Advantage Original Effective Date: 03/09/2004 Current Effective Date: 05/01/2017 POLICY A. INDICATIONS The indications below
More informationFAST FACTS Eligibility Reviewed and Verified By MD/DO/RN/LPN/CRA Date MD/DO/RN/LPN/CRA Date Consent Version Dated
Page 1 of 5 COG-ANBL1531: A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk (NBL) (IND# 134379) FAST FACTS
More informationBortezomib, Thalidomide and Dexamethasone (VTD) 28 day
Bortezomib, Thalidomide and Dexamethasone (VTD) 28 day Indication First line treatment of multiple myeloma in patients who are eligible for stem cell transplantation. (NICE TA311) ICD-10 codes Codes with
More informationClinical Trials in Myeloma and Related Disorders at PMH (Version: April 2018)
Clinical Trials in Myeloma and Related Disorders at PMH (Version: April 2018) NEWLY DIAGNOSED MULTIPLE MYELOMA Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy
More informationBCCA Protocol Summary for Curative Combined Modality Therapy for Carcinoma of the Anal Canal Using Mitomycin, Capecitabine and Radiation Therapy
BCCA Protocol Summary for Curative Combined Modality Therapy for Carcinoma of the Anal Canal Using Mitomycin, and Radiation Therapy Protocol Code: Tumour Group: Contact Physician: GICART Gastrointestinal
More informationSWOG ONCOLOGY RESEARCH PROFESSIONAL (ORP) MANUAL RESPONSE ASSESSMENT MYELOMA CHAPTER 11C REVISED: SEPTEMBER 2016
MYELOMA Quantitative Markers-Myeloma Assessment Quantitative markers are biochemicals that are recorded in tests on body fluids such as serum and urine. Applicable Disease Sites The myeloma disease site
More informationPanitumumab After Resection of Liver Metastases From Colorectal Cancer in KRAS Wild-type Patients
1 von 5 23.11.2011 10:52 Home Search Study Topics Glossary Full Text View Tabular View No Study Results Posted Related Studies Panitumumab After Resection of Liver Metastases From Colorectal Cancer in
More informationTrial record 1 of 1 for: Previous Study Return to List Next Study
A service of the U.S. National Institutes of Health Trial record 1 of 1 for: GMMG-HD6 Previous Study Return to List Next Study A Phase III Trial on the Effe ct of Elotuzumab in VRD Induction /Consolidation
More informationSynopsis. Adalimumab M Clinical Study Report R&D/09/060. (For National Authority Use Only) to Part of Dossier: Name of Study Drug:
Synopsis Abbott Laboratories Name of Study Drug: Individual Study Table Referring to Part of Dossier: Volume: (For National Authority Use Only) Name of Active Ingredient: Page: Title of Study: A Multi-Center,
More informationVelcade (bortezomib)
Velcade (bortezomib) Line(s) of Business: HMO; PPO; QUEST Integration Medicare Advantage Original Effective Date: 03/09/2004 Current Effective Date: 03/01/2018 POLICY A. INDICATIONS The indications below
More informationThe drug cost of lenalidomide for people who remain on treatment for more than 26 cycles will be met by the company.
LENALIDOMIDE MDS NICE TA322 Treatment of patients with transfusion-dependent anaemia (< 8 consecutive weeks without RBC transfusions within 16 weeks prior to commencing treatment) due to low- or intermediate-1-risk
More informationCOG-ACNS1123: Phase 2 Trial of Response-Based Radiation Therapy for Patients with Localized Central Nervous System Germ Cell Tumors (CNS GCT)
Page 1 of 6 COG-ACNS1123: Phase 2 Trial of Response-Based Radiation Therapy for Patients with Localized Central Nervous System Germ Cell Tumors (CNS GCT) FAST FACTS Eligibility Reviewed and Verified By
More informationHSV1716 Dose levels and Cohort size Dose level No of Patients HSV1716 Dosage 1* 3 to 6 1 ml of 1 x 10 5 infectious units HSV1716 per ml 2
Abstract and Schema: Description and Rationale: Pediatric high grade gliomas have a progressive initial course and high risk of relapse/ progression; making the 5-year overall survival rate 15-35% with
More informationDERBY-BURTON LOCAL CANCER NETWORK FILENAME Lenalidomide_MDS.DOC CONTROLLED DOC NO: HCCPG B78 CSIS Regimen Name: LEN_MDS.
Lenalidomide Available for Routine Use in Burton in-patient N/A Derby in-patient Burton day-case Derby day-case Burton outreach chemotherapy clinic N/A Derby outreach chemotherapy clinic Burton out-patient
More informationPlasma Cell Disorders (PCD) Pre-HCT Data
Plasma Cell Disorders (PCD) Pre-HCT Data Registry Use Only Sequence Number: Date Received: CIBMTR Center Number: CIBMTR Recipient ID: Date of HCT for which this form is being completed: HCT type: (check
More informationManagement of Multiple Myeloma: The Changing Paradigm
Management of Multiple Myeloma: The Changing Paradigm High-Dose Chemotherapy and Stem Cell Transplantation Todd Zimmerman, MD University of Chicago Medical Center Case Presentation R.M. is a 64 year old
More informationNivolumab (BMS )
Product Name Active substance Indication and conditions of use Opdivo Nivolumab (BMS-936558) Provide an option for patients suffering from locally advanced and metastatic Non Small Cell Lung Cancer (NSCLC)
More informationPomalidomide and Dexamethasone INDICATIONS FOR USE:
Pomalidomide and INDICATIONS FOR USE: INDICATION Treatment in combination with dexamethasone of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment
More informationNP30179 Eligibility Screening Form (ESF) Version 3.0
(ESF) Version 3.0 Site Number: birthdate: Screening number: page 1/6 Patients must meet the following criteria for study entry: Inclusion Criteria Note that if any box is marked NO, the patient is not
More informationBR for previously untreated or relapsed CLL
1 Protocol synopsis Title Rationale Study Objectives Multicentre phase II trial of bendamustine in combination with rituximab for patients with previously untreated or relapsed chronic lymphocytic leukemia
More informationForms Revision: Myeloma Changes
Sharing knowledge. Sharing hope. Forms Revision: Myeloma Changes J. Brunner, PA-C and A. Dispenzieri, MD February 2013 Disclosures Janet Brunner, PA-C I have no relevant conflicts of interest to disclose.
More information2016: Plasma Cell Disorders Pre-HCT Data
2016: Plasma Cell Disorders Pre-HCT Data Registry Use Only Sequence Number: Date Received: Key Fields CIBMTR Center Number: Date of HCT for which this form is being completed: / / YYYY MM DD HCT type (check
More informationPomalidomide and Dexamethasone Therapy
INDICATIONS FOR USE: Pomalidomide and Therapy Regimen Code INDICATION ICD10 Treatment in combination with dexamethasone of adult patients with relapsed and refractory multiple myeloma who have received
More informationMajor Diagnostic Criteria
Multiple Myeloma Elizabeth Ann Coleman, PhD, RNP, AOCN Professor and Chair, Dept. of Nursing Science Cooper Chair in Oncology Nursing, College of Nursing Professor, Dept. of Internal Medicine, College
More informationREVLIMID is only available through a restricted distribution program, REVLIMID REMS. Please see additional Important Safety Information on pages
REVLIMID is only available through a restricted distribution program, REVLIMID REMS. Please see additional Important Safety Information on pages 11-12 and accompanying full Prescribing Information, including
More informationB. PANITUMUMAB DOSE LEVEL 0 No dose reduction 1 Level -1 2 Level Other, specify in comments for this cycle
Radiation Therapy Oncology Group Phase II Study Pre-operative Chemo- Radiation + Panitumumab for Potentially Operable Lung Cancer Concurrent Summary Form AMENDED DATA YES INSTRUCTIONS: Submit all pages
More informationBC Cancer Protocol Summary for Therapy of Acute Myeloid Leukemia Using azacitidine and SORAfenib
BC Cancer Protocol Summary for Therapy of Acute Myeloid Leukemia Using azacitidine and SORAfenib Protocol Code Tumour Group Contact Physician ULKAMLAS Leukemia/BMT Dr. Donna Hogge ELIGIBILITY: Acute myeloid
More informationPrescriber and Pharmacy Guide for the Tracleer REMS Program
Prescriber and Pharmacy Guide for the Tracleer REMS Program Please see accompanying full Prescribing Information, including BOXED WARNING for hepatotoxicity and teratogenicity. Introduction to Tracleer
More informationFeasibility Trial of Optune for Children with Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma
Feasibility Trial of Optune for Children with Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma ABSTRACT Recurrent or progressive pediatric CNS tumors generally have a poor prognosis
More informationLIVE LONGER. Chart a course that could help you. If multiple myeloma comes back:
1 If multiple myeloma comes back: Chart a course that could help you 1 LIVE LONGER -3 In two clinical studies with patients with relapsed multiple myeloma, two KYPROLIS -based combinations kept multiple
More informationPractical Considerations in Multiple Myeloma: Optimizing Therapy With New Proteasome Inhibitors
Welcome to Managing Myeloma. My name is Dr. Donald Harvey. I am Director of Phase 1 Clinical Trials Section and an Associate Professor in Hematology, Medical Oncology, and Pharmacology at the Winship Cancer
More informationClinical Trials in Myeloma and Related Disorders at PMH (Version: May 2018)
Clinical Trials in Myeloma and Related Disorders at PMH (Version: May 2018) NEWLY DIAGNOSED MULTIPLE MYELOMA Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy
More informationFAST FACTS Eligibility Reviewed and Verified By MD/DO/RN/LPN/CRA Date MD/DO/RN/LPN/CRA Date Consent Version Dated
Page 1 of 8 COG-AALL1131: A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (IND#73789, NSC#732517) in Patients with Ph-like
More informationSupplementary Appendix
Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Lonial S, Dimopoulos M, Palumbo A, et al. Elotuzumab therapy
More informationFAMILY PLANNING AND AUBAGIO (teriflunomide)
FAMILY PLANNING AND AUBAGIO (teriflunomide) INDICATION AUBAGIO (teriflunomide) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. IMPORTANT SAFETY INFORMATION WARNING:
More informationFuel your determination to live longer with KYPROLIS. Look inside to learn more.
F O R R E L A P S E D MULT IP L E M Y E L OM A APPROVED USES KYPROLIS is a prescription medication used to treat patients with relapsed or refractory multiple myeloma who have received one to three previous
More informationManaging Myeloma Virtual Grand Rounds Newly Diagnosed, Transplant Eligible Patient. Case Study
Managing Myeloma Virtual Grand Rounds Newly Diagnosed, Transplant Eligible Patient Case Study 2 2011 Newly Diagnosed Patient The patient is a 61-year-old Caucasian female History of high blood pressure
More informationPBTC-045: Abstract and Schema
PBTC-045: A Safety and Preliminary Efficacy trial of MK-3475 (pembrolizumab; anti-pd-1) in Children with recurrent, progressive or refractory high-grade gliomas (HGG) and DIPGs Abstract and Schema This
More informationDTPACE. Myeloma group INDICATION
INDICATION Relapsed or refractory myeloma patients suitable for intensive salvage chemotherapy. Plasma cell leukaemia or presentation with extra-medullary disease. TREATMENT INTENT Disease Modification
More information10 th June Dear Healthcare Professional,
Celgene Limited 1 Longwalk Road Stockley Park Uxbridge UB11 1DB United Kingdom Tel: +44 (0)208 831 8300 Fax: +44 (0)208 831 8301 www.celgene.com 10 th June 2013 Dear Healthcare Professional, Important
More informationIn- and exclusion criteria
In- and exclusion criteria Kerstin Schütte Department of Gastroenterology, Hepatology and Infectious Diseases University of Magdeburg Overview: Study population Inclusion criteria I - General criteria
More informationInstructions for Plasma Cell Disorders (PCD) Post-HCT Data (Form 2116 Revision 3)
(Form 2116 Revision 3) This section of the CIBMTR Forms Instruction Manual is intended to be a resource for completing the Plasma Cell Disorders (PCD) Post-HCT Data Form. E-mail comments regarding the
More informationCDX1135: A Drug Trial for DDD
CDX1135: A Drug Trial for DDD In late 2012, the Food and Drug Administration (FDA) approved a drug trial to test CDX-1135 in pediatric and adult patients with Dense Deposit Disease (DDD). This is the FIRST-EVER
More informationCOG-ACNS1422: A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients
Page 1 of 5 COG-ACNS1422: A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients FAST FACTS Eligibility Reviewed and Verified By MD/DO/RN/LPN/CRA Date MD/DO/RN/LPN/CRA
More informationPankoMab-GEX Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer
1 von 7 13.01.2014 12:26 A service of the U.S. National Institutes of Health Trial record 1 of 1 for: GEXMab25201 Previous Study Return to List Next Study PankoMab-GEX Versus Placebo as Maintenance Therapy
More informationCriteria for Disease Assessment Joan Bladé
Criteria for Disease Assessment Joan Bladé Unidad de Amiloidosis y Mieloma Servicio de Hematología Hospital Clínic de Barcelona COMy Meeting, París, May 4th, 2018 Response Evaluation EBMT, 1998 - CR and
More informationAna Luisa Stuckett, PhD, MS
Ana Luisa Stuckett, PhD, MS alstuckett@mdanderson.org Clinical Studies Coordinator Investigational Cancer Therapeutics (Phase I) MD Anderson Cancer Center Houston, Texas Education Ph.D., Microbiology,
More informationSerum Free Light Chains should be the target of response evaluation in light chain myeloma rather than urines: results from the IFM 2009 trial
Serum Free Light Chains should be the target of response evaluation in light chain myeloma rather than urines: results from the IFM 2009 trial Jill Corre*, Thomas Dejoie, Helene Caillon, Michel Attal*,
More informationREGISTRATION FORM 1 / 2
IDENTIFICATION AND BASELINE DATA REGISTRATION FORM 1 / 2 M Patient s initials: Sequential case N : SEX : F Date of birth: Place of birth I I Centre I I Address I I Telephone number I I Actual profession
More informationA AMG DRAFT DATES. Version Draft Recvd Completed Initial LDM Update v Jan18 10Jan18 Imperial Shwetha Chandiramani New
DRAFT DATES Version Draft Recvd Completed Initial LDM Update v0.0 0.0.1 10Jan18 10Jan18 Imperial Shwetha Chandiramani New Site. Subject ID. INCLUSION CRITERIA: NOTE: The subject is not eligible for the
More informationDaunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Find Studies About Studies Submit Studies Resources About Site Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia The safety and scientific validity
More informationREVLIMID Dosing Guide
REVLIMID Dosing Guide Convenient Once-Daily Oral Dosing for MM, MCL, and MDS 1 REVLIMID (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of patients with multiple myeloma
More information