Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Preleukemia

Myelodysplastic Syndromes

Anemia, Refractory, with Excess of Blasts

Anemia

Anemia, Refractory

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Myelodysplastic Syndrome With Excess Blasts

Antineoplastic Agents

All Drugs and Chemicals

Azacitidine

Bone marrow aspiration after 3 cycles of Azacytidine treatment

Myelogram

Julien BROSÉUS, MD, PhD

Aurore PERROT, MD, PhD

Julien BROSEUS, MCU-PH

Julien BROSEUS

Myelodysplastic syndromes (MDS) are the most frequent myeloid neoplasms in Western Countries.They mainly affect patients aged 65 years or older. This is a very heterogenous group of diseases, which prognosis is evaluated with International Prognosis Scoring System. High risk MDS present with high frequency of transformation into acute myeloid leukemia. Treatment of high risk MDS often is based on hypomethylating agents, such as 5'-azacytidine (Azacytidine), with a complete response in approximativel 20% of cases..

This treatment is based on 4-week cycles, with daily injection during the first week and rest during the 3 next weeks of the cycle.

Azacytidine efficacy is commonly evaluated with clinical and biological parameters determined by the International Working Group 2006. These parameters are usually evaluated after at least 6 cycles of treatments.

There is a response with Azacytidine treatment in 60% of cases, including 40% of partial responses and 20% of complete responses. In 40% of patients, there is no response, which means that the disases is stable or in progression under therapy.

In this regard, early evaluation of treatment response is an issue. We want to improve our knowledge about early response criteria in Azacytidine-treated high-risk MDS, focusing on SMD with excess blasts, which represent 30 to 40% of total MDS.

Then, the investigator team want to compare DNA methylation profile at diagnosis and after 3 cycles of Azacytidine treatment.

Main objective :

Identify DNA methylation profiles related to response to Azacytidine therapy, after only 3 cycles of treatment, in high risk MDS with excess blasts.

Secondary objective :

Identify at diagnosis DNA methylation profiles that are predicitive of response to Azacytidin, in high risk MDS with excess blasts.

High Risk Myelodysplasia Treated by Azacytidine : Genetic and Epigenetic (MYRAGE)

Inserm U954 - N-GERE (Nutrition, Genetics and Exposition to Environmental Risk)

Central Hospital, Nancy, France

Immune System Diseases

Leukemia

Lymphoma

Pain

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

Analgesics

Vasodilator Agents

Respiratory System Agents

Lidocaine

Anesthetics

Nitrous Oxide

Anesthetics, Local

Prilocaine

Nitric Oxide

Lidocaine, Prilocaine Drug Combination

Sodium Channel Blockers

Diuretics, Potassium Sparing

Anesthetics, Inhalation

Anesthetics, General

Analgesics, Non-Narcotic

Inhalation of oxygen and nitrous oxide 50%

Livopan

EMLA

Yerkes P Silva, PhD

In this randomised controlled study the investigators intended to compare the analgesic effects of EMLA and\\or nitrous oxide in children submitted to lumbar puncture.

It is a randomized controlled clinical trial, double blinded, with the purpose to compare the use of EMLA - local anesthetic (lidocaine and prilocaine), and or nitrous oxide at 50% in oxygen (Livopan®) to prevent and treat pain in pediatric patients aged four to 16 years old submitted to lumbar puncture for intrathecal chemotherapy. Pain was assessed using the Wong Baker faces scale and the visual numeric scale during six observational periods: baseline; three minutes after gas administration and before the first attempt of lumbar puncture; during the first lumbar puncture attempt; during the chemotherapy administration; during needle remove and three minutes after gas interruption. All the studied procedures will have clinical indication and will not be held by the researcher. The children was random divided within three groups A, B and C as follow: Group A (n=16)EMLA + Livopan; Group B (n=19)EMLA + gas placebo (oxygen); Group C (n=17) Livopan® + placebo cream.

Primary outcome was the detection of a difference of 20% or more in the visual numeric scale between the three treatment groups during the first attempt of lumbar puncture.

Evaluation of the Analgesy With Emla and/or Nitrous Oxide in Pediatric Patients for Lumbar Puncture

Evaluation of the Analgesy Using a Local Anesthetic (Lidocaine and Prolocaine) Eutectic Mixture and/or Nitric Oxide at 50% in Oxygen (Livopan®) in Pediatric Patients That During Lumbar Puncture

Federal University of Minas Gerais

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Smoldering Multiple Myeloma

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Hypergammaglobulinemia

Each patient included in the study will be followed for 5 years

Two additional myelograms will be performed comparing to standard of care.

Pr. Olivier Decaux

This study is a prospective open label interventional multicenter study evaluating the impact of the update multiple myeloma criteria on the natural history of smoldering myeloma in order to establish new recommendations about follow up and prognostic evaluation of smoldering myeloma.

In 2014, the International Myeloma Working Group (IMWG) proposed a revised classification of multiple myeloma (MM) and smoldering myeloma (SMM). Since the new definition of SMM proposed excludes "ultra-high risk SMM", the evolution profile of SMM will change. Therefore, investigators need to update their knowledge of SMM to optimize the management of patients. This project is expected to describe more precisely the new landscape of SMM.

The results will help to establish new recommendations for the standard care of SMM and especially for defining accurate follow-up and risk stratifying.

Evaluation of the Impact of the Update SMM Criteria on the Natural History of SMM to Establish New Recommendations.

Evaluation of the Impact of the Update Multiple Myeloma Criteria on the Natural History of Smoldering Myeloma in Order to Establish New Recommendations About Follow-up and Prognostic Evaluation of Smoldering Myeloma (CARRISMM)

Progression to MM will be defined, according to IMWG 2014 revised classification, by the apparition of one or more myeloma defining events:

* Evidence of end organ damage that can be attributed to the underlying MM (CRAB criteria)
* Presence of one of the following biomarkers of malignancy (new criteria of MM introduced in 2014 IMWG recommendations)

* Progression of monoclonal component level (serum M component, urine M component or FLC involved/uninvolved) defined by increase of ≥ 25% from inclusion value.
* Progression of percentage of phenotypically abnormal Bone Marrow Plasma Cells defined by increase of ≥ 10 % from inclusion value or an increase to over 95%

MRI progression : Progression of MRI abnormalities defined by any one or more of the following

* Appearance of new focal lesion or new diffuse infiltration of previously unaffected regions
* Growth of previously preexisting \< 5mm focal(s) lesion(s)
* Progressive diffuse infiltration of already affected bones

Genetic analysis of bone marrow plasma cells at inclusion and during follow up to give data about the clonal and subclonal evolution of SMM (analysis of the mutations present in the tumor plasma cells, the allele frequency of each mutations, the determination of the clonal evolution mode for patients who will evolve to overt MM, the evaluation of copy number changes enabling to detect all the prognostic changes (1p32, 1q, 17p13), and (v) all the 14q32 translocations).

Intergroupe Francophone du Myelome

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
High Risk Myelodysplasia Treated by Azacytidine : Genetic and Epigenetic (MYRAGE)	NCT03217903	High-risk Myelo...	Myelogram	18 Years -	Central Hospital, Nancy, France
Evaluation of the Analgesy With Emla and/or Nitrous Oxide in Pediatric Patients for Lumbar Puncture	NCT00808171	Leukemia Non Hodgkin Lym...	Livopan Livopan EMLA	4 Years - 14 Years	Federal University of Minas Gerais
Evaluation of the Analgesy With Emla and/or Nitrous Oxide in Pediatric Patients for Lumbar Puncture	NCT00808171	Leukemia Non Hodgkin Lym...	Livopan Livopan EMLA	4 Years - 14 Years	Federal University of Minas Gerais
High Risk Myelodysplasia Treated by Azacytidine : Genetic and Epigenetic (MYRAGE)	NCT03217903	High-risk Myelo...	Myelogram	18 Years -	Central Hospital, Nancy, France
Evaluation of the Impact of the Update SMM Criteria on the Natural History of SMM to Establish New Recommendations.	NCT04144387	Smoldering Mult...	Myelogram	18 Years -	Intergroupe Francophone du Myelome

Spots Global Cancer Trial Database for myelogram

Every month we try and update this database with for myelogram cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for myelogram

Every month we try and update this database with for myelogram cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for myelogram cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.