Multiple MyelomaMYELODOMNCT04260490
Multiple Myeloma and Environmental Exposure to Pesticides in the French West Indies: A Population Based Case-control Study.
An observational study of Multiple Myeloma, run by Centre Hospitalier Universitaire de la Guadeloupe at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma
- How many people
- 600 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 19 Nov 2019to Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A case-control study in the general population with etiological aim, paired multicentric will be carried out. This choice is justified given the low frequency of the pathology studied in the two islands. Cancer registries of Guadeloupe and Martinique exhaustively collect cases of multiple myeloma (MM) according to cancer registration rules established at European and international level. They have data to identify the usual places of care and diagnosis of MM in their respective territory and work in close collaboration with clinical services in charge of patients.
Who may be able to join
- Cases :
- patients above 18 years old
- with a place of residence in Guadeloupe or Martinique
- meeting the inclusion criteria for multiple myeloma identified from hematologist, oncologist and clinicians
- who ave a written informed consent.
- Controls :
- individuals selected after stratification on department of residence, sex and age of the cases
- who gave a written informed consent to participate.
Who cannot join
- Refusal to participate
- subject not affiliated to a social welfare or under guardianship
- Pregnant or lactating woman
- Subject participating in another research including an exclusion period still in progress at the pre-inclusion
Trial locations and contacts
2 sites in 2 countries.
Mélanie MP PETAPERMAL contact
2 sites in 2 countries
Guadeloupe1 site, 1 recruiting
- Recruiting
University Hospital Center of Guadeloupe
Pointe-à-Pitre, 97159
Valérie VS SOTER, Project Manager of Reseach, 0590 93 46 86, valerie.soter@chu-guadeloupe.fr
Melanie MP PETAPERMAL, 0590 93 46 86, melanie.petapermal@chu-guadeloupe.fr
Martinique1 site, 1 recruiting
- Not yet recruiting
University Hospital Center of Martinique
Fort-de-France, 97261
Cedric CONTARET, cedric.contaret@chu-martinique.fr
Clarisse JOACHIM, MD
About this study
Official title: Multiple Myeloma in the French West Indies. Environmental and Professional Exposure to Pesticide: A Case-control Study in Guadeloupe and Martinique
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.
Read the detailed 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".
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, pesticide, chlordecone, Guadeloupe, Martinique
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Cases will be interviewed using a standardized questionnaire. Blood samples will be taken for standard and specific analyses. Samples for chlordecone and other Persistent organic Polluants (POPs) tests will be collected. Blood samples will be collected for the biobank of Guadeloupe for further studies on genetic susceptibility markers and their links with pesticide exposure. | |
| Controls | Controls selected after stratification on department of residence, sex and age of the cases and who give a written informed consent to participate. Controls will be interviewed using a standardized questionnaire. Blood samples will be taken for standard and specific analyses in both cases and controls. Samples for chlordecone and other Persistent organic Polluants (POPs) tests will be collected. Blood samples will be collected for the biobank of Guadeloupe for further studies on genetic susceptibility markers and their links with pesticide exposure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of association between exposure to chlordecone and risk of multiple myeloma.
The exposure measurement will be done using several complementary methods combining:
- Serum dosages of chlordecone + Persistent Organic Pollutant
- Evaluation from questionnaires
- Use of job-exposure matrices (benzene and other solvents), made available by the Occupational Health Department (DST) of the Institute for Health Monitoring (InVS)
- Use of crop-exposure matrices : the banana crop matrix developed for the Antilles by the DST of InVS in collaboration with the Interregional Epidemiology Unit (CIRE) Antilles Guyane and will be used
Measured: Pesticide samples will be sent to the Reference Laboratory of Animal Ecology and Ecotoxicology in Liège once or twice a year. For a given patient, the time frame (questionnaire + and blood analyses) will be 12 months after inclusion.
Secondary outcomes (1)
proportion of MM cases attributable to pesticide exposure
Measured: 36 months after first inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start19 Nov 2019
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Collaborators
- Guadeloupe Cancer Registry, Martinique Cancer Registry, Institut National de la Santé Et de la Recherche Médicale, France, University of Liege, University Hospital Center of Martinique, Centre Hospitalier de Basse-Terre
- Responsible party
- Sponsor
- Investigators
- Jacqueline Deloumeaux, MD, Principal investigator, CHU de la Guadeloupe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260490
- Sponsor's protocol ID
- PAP_RI2_2018/01
- Acronym
- MYELODOM
- Status last verified
- Feb 2020
- First submitted
- 5 Feb 2020
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flowers CR, Glover R, Lonial S, Brawley OW. Racial differences in the incidence and outcomes for patients with hematological malignancies. Curr Probl Cancer. 2007 May-Jun;31(3):182-201. doi: 10.1016/j.currproblcancer.2007.01.005. No abstract available.
PubMed 17543947Multigner L, Ndong JR, Giusti A, Romana M, Delacroix-Maillard H, Cordier S, Jegou B, Thome JP, Blanchet P. Chlordecone exposure and risk of prostate cancer. J Clin Oncol. 2010 Jul 20;28(21):3457-62. doi: 10.1200/JCO.2009.27.2153. Epub 2010 Jun 21.
PubMed 20566993
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Myeloma in the French West Indies. Environmental and Professional Exposure to Pesticide: A Case-control Study in Guadeloupe and Martinique
- ClinicalTrials.gov ID
- NCT04260490
- Acronym / sponsor ID
- MYELODOM / PAP_RI2_2018/01
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, pesticide, chlordecone, Guadeloupe, Martinique
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Collaborators
- Guadeloupe Cancer Registry, Martinique Cancer Registry, Institut National de la Santé Et de la Recherche Médicale, France, University of Liege, University Hospital Center of Martinique, Centre Hospitalier de Basse-Terre
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Cases will be interviewed using a standardized questionnaire. Blood samples will be taken for standard and specific analyses. Samples for chlordecone and other Persistent organic Polluants (POPs) tests will be collected. Blood samples will be collected for the biobank of Guadeloupe for further studies on genetic susceptibility markers and their links with pesticide exposure. |
| Controls | – | –Controls selected after stratification on department of residence, sex and age of the cases and who give a written informed consent to participate. Controls will be interviewed using a standardized questionnaire. Blood samples will be taken for standard and specific analyses in both cases and controls. Samples for chlordecone and other Persistent organic Polluants (POPs) tests will be collected. Blood samples will be collected for the biobank of Guadeloupe for further studies on genetic susceptibility markers and their links with pesticide exposure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A case-control study in the general population with etiological aim, paired multicentric will be carried out. This choice is justified given the low frequency of the pathology studied in the two islands. Cancer registries of Guadeloupe and Martinique exhaustively collect cases of multiple myeloma (MM) according to cancer registration rules established at European and international level. They have data to identify the usual places of care and diagnosis of MM in their respective territory and work in close collaboration with clinical services in charge of patients.
Key inclusion criteria (8 listed)
- Cases :
- patients above 18 years old
- with a place of residence in Guadeloupe or Martinique
- meeting the inclusion criteria for multiple myeloma identified from hematologist, oncologist and clinicians
- who ave a written informed consent.
Key exclusion criteria (4 listed)
- Refusal to participate
- subject not affiliated to a social welfare or under guardianship
- Pregnant or lactating woman
- Subject participating in another research including an exclusion period still in progress at the pre-inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure of association between exposure to chlordecone and risk of multiple myeloma.
Time frame: Pesticide samples will be sent to the Reference Laboratory of Animal Ecology and Ecotoxicology in Liège once or twice a year. For a given patient, the time frame (questionnaire + and blood analyses) will be 12 months after inclusion.
The exposure measurement will be done using several complementary methods combining: * Serum dosages of chlordecone + Persistent Organic Pollutant * Evaluation from questionnaires * Use of job-exposure matrices (benzene and other solvents), made available by the Occupational Health Department (DST) of the Institute for Health Monitoring (InVS) * Use of crop-exposure matrices : the banana crop matrix developed for the Antilles by the DST of InVS in collaboration with the Interregional Epidemiology Unit (CIRE) Antilles Guyane and will be used
1 secondary outcome
proportion of MM cases attributable to pesticide exposure
Time frame: 36 months after first inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Background: PubMed 17543947Flowers CR, Glover R, Lonial S, Brawley OW. Racial differences in the incidence and outcomes for patients with hematological malignancies. Curr Probl Cancer. 2007 May-Jun;31(3):182-201. doi: 10.1016/j.currproblcancer.2007.01.005. No abstract available.
- Background: PubMed 20566993Multigner L, Ndong JR, Giusti A, Romana M, Delacroix-Maillard H, Cordier S, Jegou B, Thome JP, Blanchet P. Chlordecone exposure and risk of prostate cancer. J Clin Oncol. 2010 Jul 20;28(21):3457-62. doi: 10.1200/JCO.2009.27.2153. Epub 2010 Jun 21.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mélanie MP PETAPERMAL contact
Jacqueline Deloumeaux, MD principal investigator
CHU de la Guadeloupe
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Centre Hospitalier Universitaire de la Guadeloupe at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Guadeloupe, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerie VS SOTER, MD (+590590934686, valerie.soter@chu-guadeloupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of association between exposure to chlordecone and risk of multiple myeloma. (time frame: Pesticide samples will be sent to the Reference Laboratory of Animal Ecology and Ecotoxicology in Liège once or twice a year. For a given patient, the time frame (questionnaire + and blood analyses) will be 12 months after inclusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04260490, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.