Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasm, Residual

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Dermatologic Agents

All Drugs and Chemicals

Coal Tar

Patients continue treatment until complete remission with negative MRD and Image is achieved, changing the therapeutic line if this is not achieved with the prescribed treatment. In this group of patients, treatment is suspended only when this degree of profound response is reached, in any phase of treatment.

The patients of the conventional treatment group (control group) received six cycles of the induction traetment, bone marrow auto-transplantation, and consolidation treatment after transplantation if complete remission had not been achieved.

Instead of receiving a pre-specified number of treatment cycles, regardless of the result obtained, in the MRDI-driven treatment group patients continue receiving treatment until reaching a complete remission with negative MRD and Image, changing the therapeutic line if it is not obtained with the line current therapy. In this group of the patients the treatment was stopped only when this degree of deep response was achieved.

Continued treatment adapted to the response

Jose Enrique de la Puerta Rueda, MD

To assess whether continued treatment to achieve negative Minimal Residual Disease and Imaging (MRDI(-)) improves therapeutic outcomes in patients with newly diagnosed Multiple Myeloma. The primary endpoints are progression-free survival (PFS) and overall survival (OS). The safety evaluation includes the evaluation of adverse events, which are classified according to the Common Criteria for Terminology for Adverse Events of the National Cancer Institute, version 5.0.

Material and methods - Criteria for Enrollment Patients younger than 76 years, diagnosed with myeloma since July 1, 2014 until May 31, 2019, without a contraindication for bone marrow auto-transplantation are included in the study. Fragile patients with severe senile dementia, with another non-treatable neoplasm, or with significant comorbidity in whom the therapeutic objective was only palliative are not included in the study. The allocation to each treatment group was carried out according to the patient's preferences and his/her responsible physician, giving the patient his/her consent for treatment in all cases. In addition to other information, before patients gave their consent, patients included in the continued treatment group were clarified that it was a non-standard treatment, giving them the choice between the most common option of fixed treatment or continuous treatment up to Minimal Residual Disease and Image negative (MRDI(-)).

Material and methods - Study Design and Treatment This is a study of the patients treated in real life hematology. It is a cohort study to compare continuous treatment versus fixed-duration therapy. The study is conducted in a single hospital, including patients diagnosed from July 1, 2014 to May 31, 2019. The autotransplant is considered as a therapeutic line more, and all patients who did not receive the transplant were analyzed as if they had received it. The patients always receive some of the authorized treatments for their therapeutic line, according to the preferences of the responsible hematologist and the patient. After the induction phase, all the patients undergo stem-cell mobilization with granulocyte colony-stimulating factor.

The patients of the fixed treatment group (control group) receive up to six cycles of the consolidation treatment after transplantation if complete remission has not been achieved.

In the patients of the MRDI-driven group, patients continue treatment after transplantation to achieve complete remission with negative MRD and negative image, changing therapeutic line if not achieved with the prescribed treatment. In this group of the patients the treatment is stopped only when this degree of deep response is achieved, in whatever the treatment phase was.

Assessments The treatment response and disease progression are assessed according to the International Uniform Response Criteria for Multiple Myeloma, except that to consider the negative Minimal Residual Disease, a sensitivity level of 10-6 is required. In addition, it is considered negative image only if a Positron Emission Tomography/Computed Tomography (PET/CT) body and spinal and pelvic Nuclear Magnetic Resonance (NMR), are both negative.

The work team defined an additional category of relapse: "relapse from MRDI(-)", which includes any of the relapse criteria of negative Minimal Residual Disease, and/or positive image. To evaluate the Positron Emission Tomography/Computed Tomography (PET/CT) the criteria of Elena Zamagni are used. In Nuclear Magnetic Resonance studies, all lesions with a size equal to or greater than 5 mm are considered positive if they are hypointense signal in T1, hyperintense in Fat Suppression (FS) T2 signal, and in the studies of diffusion hyperintense signal in b1000 with apparent diffusion coefficient (ADC) between 0.4 and 1. In perfusion studies, type 4-curve lesions are considered positive. The adverse events are assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 of the National Cancer Institute. It is considered as an Adverse Event (AE) any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.

Among all the patients, bone marrow samples are obtained at diagnostic for cytogenetic evaluation.

Among the patients of the MRDI-driven group who are a complete response, bone marrow samples are obtained for minimal residual disease evaluation by means of seven-color flow cytometry (which has a sensitivity level of 10-6, indicating that it can detect 1 malignant plasma cell within 1,000,000 bone marrow cells). If the patient achieve a Complete Remission (CR) according to the International Uniform Response Criteria for Multiple Myeloma, Minimal Residual Disease (MRD) and imaging studies are performed before transplantation, after transplantation, and after every six cycles of treatment in cases with CR where previous MRD or imaging studies are positive.

In the control group, the MRD and imaging only occasionally is it evaluated. In all patients who achieve a negative MRD and negative image, MRD and imaging tests are performed at 6 months and annually.

The response obtained, progression-free survival, overall survival, and the incidence of adverse effects are valued.

Statistical Analysis Progression-free survival is defined as the time from start of treatment until either the first documentation of disease progression or death owing to myeloma or not. Overall survival is defined as the time from start of treatment until death from any cause.

Duration of PFS and OS is estimated by means of the test of the long rank Kaplan-Meier method with Cox analysis. Analyses are performed with the use of IBM SPSS Statistics software, version 23.0; the data cutoff date is June 30, 2024.

Prospective, no randomized. It is a cohort study to compare MRDI(-) driven treatment adapted to the response versus fixed-duration therapy.

Efficacy of Response-adapted Treatment in Patients With Multiple Myeloma Candidates for Bone Marrow Transplantation

Efficacy of Response-adapted Treatment Guided by Negative Minimal Residual Disease and Negative Imaging (MRDI) in Fit Patients Diagnosed With Multiple Myeloma Who Are Candidates for Bone Marrow Transplantation

At this time, no plan has been developed to make individual participant data (IPD) available to other researchers.

Time elapsed from start of treatment until first documentation of disease progression or date of death from any cause, whichever came first.

Time from start of treatment to death from any cause

Number of patients with any adverse event grade 3 or higher, divided by the total number of patients in the corresponding group

Number of grade 3 or higher adverse events in the group divided by the number of patients in the group

Number of grade 3 or higher adverse events in the group divided by the sum of the years of observation of the group members

Hospital Galdakao-Usansolo

Principal Investigator

Neoplasm Metastasis

Fatigue

The sample will receive of a Therapeutic Exercise and Education programme

Intervention will consisted of 30 minutes of strength exercises followed by 20 minutes of endurance with aerobic training, individualised based on the evaluations of muscular strength and endurance as well as the determination of the aerobic-anaerobic zone transition. Sessions lasted 1 hour, carried out twice a week, during 12 weeks. This intervention will be complemented by nutritional education.

Therapeutic Exercise and Education

The aim is to analyse the effect of a Therapeutic Exercise and Education programme in several clinical and functional outcomes in cancer patient and survivors

In the oncology field, both patients and survivors have to face several symptoms, like cancer-related fatigue or pain. Cancer patients also have affected quality of life, lower levels of function and they are at higher risk of weight gain following diagnosis. Given the risk of obesity, both exercise and diet play a key role in recovery from cancer.

Hence, the aim of this study is to show the effect of a Therapeutic Exercise and Education programme (TEEP) in clinical and functional, including practical nutritional education in other clinical and functional secondary outcomes in cancer patients and survivors.

Variables included are: body composition, mediterranean-diet adherence, quality of life (QoL) and functional outcomes (limb functionality, physical activity, physical function and handgrip strength). Furthermore, laboratory variables like muscle thickness (ecography) and muscle activity (electromyography) were included.

Clinical and Functional Variables in Oncology

Clinical and Functional Variables in the Assessment of Oncology Patient

The Spanish version of the Piper Fatigue Scale-Revised (PFS-R) will be used

It will be tested by 30-second Sit-To-Stand Test (30-STS), number of repetitions completed.

the Spanish version of Upper Limb Functional Index (ULFI) questionnaire will be filled

the Spanish version of the Lower Limb Functional Index (LLFI) questionnaire will be filled

BMI, basal metabolism, fat/lean mass and water balance will be measured by Tanita TBF-300A

Body Mass Index calculated based on weight and height as: kilogrames (Kg)/ squared meters (Kg/m2)

the number of calories required to keep your body functioning at restm, expressed in Kcal,measured by Tanita TBF-300A

The fat mass in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A

The lean mass in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A

Water weight in the total weight of the body, expressed as Kg, measured by Tanita TBF-300A

The International Physical Activity Questionnaire-Short Form (IPAQ-SF) questionnaire will be employed

Strength will be recorded by Jamar Hydraulic Hand Dynamometer Model SH5001

It will be assessed by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0

It will be assessed by The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life questionnaire (EORTC QLQ-BR23)

In biceps and cuadriceps muscles, both during relaxation and contraction.

maximal handgrip strength measured by a The Jamar® Hand Dynamometer (expressed in Kg)

University of Malaga

Principal Researcher of CTS631 University of Malaga

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Hormones

Before treatment, the patients in the study group underwent NGS detection of ctDNA and formulated endocrine treatment plan according to the test results. After 2 months of endocrine therapy, all patients underwent NGS detection of ctDNA, and the efficacy was evaluated according to RECIST v1.1 standard.

The NGS detection panel is designed by our team and covers genes that are clinically useful and have definite guiding significance for endocrine therapy

Next Generation Sequencing (NGS) detection

Fei Ma, Dr.

To determine the landscape of gene mutation before and after endocrine therapy, to search for molecular markers of endocrine therapy efficacy, and to explore the clinical value of using NGS detection of ctDNA to guide precise endocrine therapy in patients with advanced breast cancer. The primary endpoints were progression-free survival (PFS), and the secondary endpoints included overall survival time (OS), adverse events (AE), and severe adverse events (SAE).

Before treatment, the patients in the study group underwent NGS detection of ctDNA and formulated treatment plan according to the test results: 1) those with ESR1 mutation and who did not use fulvestrant before, preferred fulvestrant; 2) those with abnormal activation of PI3K/Akt/mTOR pathway signal, preferred mTOR inhibitor combined with endocrine therapy; 3) those with HER-2 sensitive point mutation, preferred anti-HER-2 therapy combined with endocrine therapy; 4) PDGFR mutation, preferential use of PDGFR inhibitors combined with endocrine therapy; 5) no significant gene mutation, making endocrine therapy plan according to the actual clinical situation. After 2 months of endocrine therapy, all patients underwent NGS detection of ctDNA, and the efficacy was evaluated according to RECIST v1.1 standard. If the efficacy evaluation is effective, continue the current treatment and re-evaluate the efficacy every two months; if the efficacy evaluation is ineffective (progress), then withdraw from this study. The vital signs, blood routine, liver and kidney functions and imaging examinations were examined at least every two months in the patients in the study group, and the curative effect was evaluated according to RECIST v1.1 standard.

Clinical Value of Next Generation Sequencing in Endocrine Therapy for Advanced Hormone Receptor Positive/HER-2 Negative Breast Cancer

From date of first use endocrine treatment until the date of first documented progression or date of death from any cause, whichever came first

Time from first use endocrine treatment to death

Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0)

Peking Union Medical College

Deputy Director of Oncology Medicine

Nervous System Diseases

Brain Neoplasms

Meningioma

Neoplasms, Nerve Tissue

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Central Nervous System Depressants

Anesthetics

Therapeutic endovascular embolization in general anesthesia

Endovascular embolization

Ole Solheim, PhD

Ole Solheim, MD, PhD

The natural course for meningioma suggests that a majority will grow over time. Treatment is usually indicated in growing or symptomatic meningiomas. Surgery is usually primary treatment, but there is a significant risk of adverse effects. Stereotactic radiotherapy is most often reserved to treat relapses after surgery, and except for surgery and radiotherapy there are no other established treatment methods. Endovascular embolization may be used in selected cases as a preoperative adjunct to reduce intraoperative bleeding. There is a need for more treatment options in patients with meningioma, both in uncomplicated, asymptomatic cases and in more complex cases. The aim of this study is to assess radiological and clinical results of therapeutic endovascular embolization for meningioma

Historical controls from a regional brain tumor registry

Embolization for Meningioma

Therapeutic Endovascular Embolization for Intracranial Meningioma

Landriel Ibanez classification (grade 3 or 4 complications)

The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire

The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BN20 questionnaire

National Institutes of Health Stroke Scale (NIHSS)

\>10 points in Karnofsky performance status

St. Olavs Hospital

Digestive System Diseases

Infections

Ulcer

Stomach Neoplasms

Communicable Diseases

Helicobacter Infections

Peptic Ulcer

Disease Attributes

Bacterial Infections

Gram-Negative Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Stomach Cancer

Anti-Infective Agents

Gastrointestinal Agents

Metronidazole

Amoxicillin

Esomeprazole

Clarithromycin

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Enzyme Inhibitors

esomeprazole and amoxicillin and clarithromycin and metronidazole for 10 days

esomeprazole and amoxicillin for 5 days, followed by esoprazole and clarithromycin and metronidazole for 5 more days

esomeprazole (40 mg daily) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, metronidazole (500 mg, bid) from day 6 to day 10

10-day sequential treatment

esomeprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 10, clarithromycin (500 mg, bid) from day 1 to day 10, metronidazole (500 mg, bid) from day 1 to day 10

10-day concomitant therapy

Ching-Kuan Liu, MD, PhD

David Y Graham, MD

Antone R Opekun, PA-C

Deng-Chyang Wu, MD PhD

Helicobacter pylori is a bacteria that infects the lining of the stomach and is associated with ulcers. Helicobacter pylori may also increase the long-term risk of developing certain forms of gastric cancer. Curing this infection generally requires that patients take 2 or more antibiotic medications and a stomach acid suppressing medication for about two weeks. Current treatments do not always cure the infection and a new treatment is being tested in this study. The drugs involved in the new 4 drug treatment have been widely used for treatment of this infection. It remains unknown what is the best and most cost effective way to give them. This study will compare three different ways of using these drugs.

Subjects must have active Helicobacter pylori infection in order to participate in this study.

The purpose of this study is to compare different methods of giving combination drug therapy for treating Helicobacter pylori infection of the stomach. The entire study will last less than 2 years. Each subject will be participating in the study for approximately 60 days.

A total of 360 subjects will be asked to participate in this study.

Before participating in this study, subject's must have undergone to confirm the presence and to assess the susceptibility of Helicobacter pylori. Qualified subjects will receive 4 drugs which are to be taken as part of the study treatment: an acid suppressing drug (name), amoxicillin, clarithromycin and metronidazole. The doses are 1 grams of amoxicillin, 40 mg of esomeprazole (Nexium), 500 mg of metronidazole and 250 mg of clarithromycin. Each drug will be given twice a day to be taken twice a day with the morning and evening meals. Subjects will receive one of three different combinations. The choice of which will be randomly chosen by the use of a computer program. The regimes are: all 4 drugs daily for 5 days, all 4 drugs daily for 10 days, and two drugs (esomeprazole and amoxicillin) for 5 days then all for drugs for 5 additional days.

Subjects will be asked to return within 4 days after completion of the treatment to evaluate how they did with the drugs. They will be asked bring back all unused medication and the bottles or containers that the medicine was packaged in. Your medication use and tolerance to the study drugs will be assessed. The treatment portion of the study will be complete at this point.

Evaluation of the effect of the treatment will take place 4-6 weeks after the end of therapy. Subjects will come back to the study site and will have a UBT or repeat endoscopy, if clinically indicated to verify that the Helicobacter pylori has been cured. Subjects will be asked not to take antibiotics or any other drugs that may affect the outcome of the breath test used to confirm that the treatment was successful.

Comparison of Sequential or Concomitant Therapy for Helicobacter Pylori Infection

Sequential Versus Concomitant Therapy for Helicobacter Pylori Infection

Evaluate eradication outcome by endoscopy urease test and histology or urea breath test

Good drug compliance is defined as taking equal to or more than 80% of eradication medicines

Baylor College of Medicine

Kaohsiung Veterans General Hospital.

Professor

esoprazole (40 mg, bid), amoxicillin (1 g, bid), clarithromycin (500 mg, bid) and metronidazole (500 mg, bid) for 10 days

Concomitant Therapy (A)

esoprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, and metronidazole (500 mg, bid) from day 6 to day 10

Sequential Therapy (B)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Taiwan

Region of Enrollment

The trial was performed in a single country

Dr. Ping-I Hsu

Number of Participants in Which H. Pylori Was Eradicated

Number of Participants Who Had Good Drug Compliance

Overall Study

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphatic Diseases

Leukemia, B-Cell

Chronic Disease

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Antineoplastic Agents

Antirheumatic Agents

Amino Acids

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Bendamustine Hydrochloride

Rituximab

Thalidomide

Ibrutinib

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Angiogenesis Inhibitors

Growth Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

FCR/BR→ ibrutinib✖️3months→FCR/BR→ ibrutinib✖️3months→FCR/BR→Maintenance therapy

Induction treatment:

Patients \<65 y and without significant comorbidities are given FCR 1or 2 courses (If patients' white blood cell count \<10×10\^9/L after first course, the second course can be saved). Then, patients takes ibrutinib orally for 3 months alternating with FCR in 2 cylcles.

1. FCR： F（Fludarabine）：25mg/m2·d，d1-3； C（Cyclophosphamide）：CTX 250mg /m2·d，d1-3； R（Rituximab）：375mg/m2 d0（first course），500mg/m2 d0（subsequent courses）；
2. Ibrutinib:420mg/d

FCR and Ibrutinib

Induction treatment:

Patients ≥65y and ≤75 y or \<65 y but with comorbidities, are given BR 1or 2 courses (If patients' white blood cell count drop to below10×10\^9/Lafter first course, the second course can be saved). Then, patients takes ibrutinib orally for 3 months alternating with BR in 2 cylcles. 1.BR： B（Bendamustine）：90mg/m2·d，d1-2； R（Rituximab）：375mg/m2 d0（first course），500mg/m2 d0（subsequent courses）； 2. Ibrutinib: 420mg/d

BR and Ibrutinib

Maintenance treatment:

After induction treatment, recommend ( but not mandatory) Ibrutinib or thalidomide monotherapy(according to patients preferrance) for MRD-positive patients.For MRD-negative patients, recommend ( but not mandatory) no maintenance therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy of Response-adapted Treatment in Patients With Multiple Myeloma Candidates for Bone Marrow Transplantation	NCT05697913	Multiple Myelom...	Continued treat...	18 Years - 75 Years	Hospital Galdakao-Usansolo
Clinical and Functional Variables in Oncology	NCT03879096	Cancer, Metasta... Cancer Survivorship	Therapeutic Exe...	18 Years - 80 Years	University of Malaga
Clinical Value of Next Generation Sequencing in Endocrine Therapy for Advanced Hormone Receptor Positive/HER-2 Negative Breast Cancer	NCT03786575	Breast Neoplasm... Therapeutics Mutation	Next Generation...	18 Years -	Peking Union Medical College
Embolization for Meningioma	NCT05416567	Meningioma	Endovascular em...	18 Years -	St. Olavs Hospital
Comparison of Sequential or Concomitant Therapy for Helicobacter Pylori Infection	NCT00656968	Helicobacter In...	10-day sequenti... 10-day concomit...	18 Years - 75 Years	Kaohsiung Veterans General Hospital.
Embolization for Meningioma	NCT05416567	Meningioma	Endovascular em...	18 Years -	St. Olavs Hospital
Efficacy of Response-adapted Treatment in Patients With Multiple Myeloma Candidates for Bone Marrow Transplantation	NCT05697913	Multiple Myelom...	Continued treat...	18 Years - 75 Years	Hospital Galdakao-Usansolo
A Prospective Multicenter Phase 2 Study of FCR/BR Alternating With Ibrutinib in Treatment-naive Patients With CLL	NCT03980002	Chronic Lymphoc...	FCR and Ibrutin... BR and Ibrutini... Ibrutinib and T...	18 Years - 75 Years	Institute of Hematology & Blood Diseases Hospital, China
Clinical Value of Next Generation Sequencing in Endocrine Therapy for Advanced Hormone Receptor Positive/HER-2 Negative Breast Cancer	NCT03786575	Breast Neoplasm... Therapeutics Mutation	Next Generation...	18 Years -	Peking Union Medical College
SmartTarget THERAPY	NCT02290561	Prostatic Neopl...	SmartTarget The... MRI high intensity ...	-	University College, London
Clinical and Functional Variables in Oncology	NCT03879096	Cancer, Metasta... Cancer Survivorship	Therapeutic Exe...	18 Years - 80 Years	University of Malaga
Embolization for Meningioma	NCT05416567	Meningioma	Endovascular em...	18 Years -	St. Olavs Hospital

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