Clinical Trials Logo

Clinical Trial Summary

Multiple myeloma (MM) is a malignancy of plasma cells engaging in monoclonal immunoglobulin production. A strong presumption was established between exposure to pesticides and the risk of MM. The French West Indies departments of Guadeloupe and Martinique are characterized by a wide use of pesticides related to bananas plantation, particularly chlordecone which has been classified by IARC as possibly carcinogenic and has recognized hormonal properties (endocrine disruptor). The objective of this study is to measure the association between exposure to pesticide and other environmental factors in the occurrence of MM in Guadeloupe and Martinique and to estimate the proportion of cases of MM attributable to pesticide exposure. Genetic susceptibility markers and their links to environmental factors will be subsequently studies from blood samples collection.


Clinical Trial Description

Multiple Myeloma (MM) is a mature B-cell lymphoma characterized by monoclonal proliferation of tumor plasma cells invading the bone marrow. It is the second malignant hemopathy among Non-Hodgkin's Lymphomas. Etiology of the disease is poorly understood. Its higher incidence in black subjects suggests the existence of genetic factors. Numerous studies have evoked the role of exposure to environmental and occupational factors in the occurrence of MM such as exposure to pesticides, solvents, in particular benzene, and other petroleum derivatives, as well as work in an agricultural environment, in hairdressing and in the metallurgical and textile industries. According to the Collective Inserm expertise "Pesticides and Health", a strong presumption (++) has been established between exposure to pesticides and the risk of occurrence of MM.

In the French West Indies (Guadeloupe, Martinique), the incidence of MM is higher than in France. These 2 departments are characterized by a major use of pesticides in connection with the banana culture developed intensively from the 1950s. These cultures successively used organochlorine insecticides, mainly β-hexachlorocyclohexane (β-HCH), technical HCH (mixture of α, β, and γ isomers of HCH), and especially chlordecone (CLD). CLD was used from 1972 to 1993 under the trade names of Kepone® (1972-1978) and then Curlone® (1982-1993) with a CLD rate of 5%. The absence of biotic and abiotic degradation of CLD has resulted in persistent soil pollution, still present today, contamination of surface and deep waters, many plant and animal products, terrestrial and marine, and then the population. CLD is a proven carcinogen in rodents, classified as a possible carcinogen by the International Agency for Research on Cancer (IARC) and has recognized hormonal properties (endocrine disruptor). CLD has been associated with an increased risk of prostate cancer in Guadeloupe. In Martinique, a geographic correlation study has shown a high incidence of MM in individuals residing on soils polluted by CLD.

Studies on the impact of pesticides on health come up against numerous limits, in the foreground of which is the great diversity of products (more than 900 active ingredients were approved one day in France and marketed in more than 9000 different products) and the difficulty in reconstructing retrospectively and objectively the exposures of individuals due to the multiplicity of sources of exposure (leisure, gardening, domestic use).

Mode of action of pesticides is still insufficiently documented, but some are classified as genotoxic, immunotoxic, tumor promoters or endocrine disruptors. Data available in the literature mainly relate to case-control or cohort studies on the occupational exposure of agricultural workers in industrialized countries. Measurement of this exposure is mainly made from self-administered questionnaires.

The investigators propose to assess feasibility of a case-control study on role of exposure to pesticides, in particular to CLD and persistent pollutants, as well as other occupational exposures in the occurrence of MM in the West Indies. This study is part of the recommendations of the Inserm-InVs Chlordecone Scientific Council and action 18 of the National Interministerial Chlordecone Plan "initiate work on the link between myelomas and exposure to chlordecone". ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04260490
Study type Observational
Source Centre Hospitalier Universitaire de Pointe-a-Pitre
Contact Valerie VS SOTER, MD
Phone +590590934686
Email valerie.soter@chu-guadeloupe.fr
Status Recruiting
Phase
Start date November 19, 2019
Completion date November 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05027594 - Ph I Study in Adult Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02412878 - Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma Phase 3
Completed NCT01947140 - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies Phase 1/Phase 2
Recruiting NCT05971056 - Providing Cancer Care Closer to Home for Patients With Multiple Myeloma N/A
Recruiting NCT05243797 - Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation Phase 3
Active, not recruiting NCT04555551 - MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma Phase 1
Recruiting NCT05618041 - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies N/A
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Completed NCT02916979 - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG Phase 1
Recruiting NCT03570983 - A Trial Comparing Single Agent Melphalan to Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preparative Regimen for Patients With Multiple Myeloma Undergoing High Dose Therapy Followed by Autologous Stem Cell Reinfusion Phase 2
Completed NCT03665155 - First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody Phase 1/Phase 2
Terminated NCT03399448 - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells) Phase 1
Completed NCT02812706 - Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients Phase 1/Phase 2
Active, not recruiting NCT05024045 - Study of Oral LOXO-338 in Patients With Advanced Blood Cancers Phase 1
Recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
Active, not recruiting NCT03792763 - Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients Phase 2
Withdrawn NCT03608501 - A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation Phase 2
Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1