Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
83 participants
OBSERVATIONAL
2023-11-20
2024-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Control Group
Thalidomide 100mg-200mg PO daily alone or in combination with dexamethasone 40mg PO every 24 hours on days 1-4, 8-11 of each cycle.
Bortezomib
Bortezomib 1.3mg/m2 SC on days 1,4, 8,11 to the TD scheme for a total of 6 treatment cycles (14,15) (VTD)
Bortezomib Group
Bortezomib 1.3mg/m2 SC on days 1,4, 8,11 to the TD scheme for a total of 6 treatment cycles (VTD).
Bortezomib
Bortezomib 1.3mg/m2 SC on days 1,4, 8,11 to the TD scheme for a total of 6 treatment cycles (14,15) (VTD)
Interventions
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Bortezomib
Bortezomib 1.3mg/m2 SC on days 1,4, 8,11 to the TD scheme for a total of 6 treatment cycles (14,15) (VTD)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Clinical records of patients who abandoned treatment or could not continue with the treatment due to economic or distance issues
* Clinical records of patients who presented severe sepsis before the beginning of either treatment
18 Years
90 Years
ALL
No
Sponsors
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Hospital General de Mexico
OTHER_GOV
Responsible Party
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Christian Omar Ramos-Peñafiel, MD, PhD
Principal investigator
Principal Investigators
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Adolfo O Martinez Tovar, PhD
Role: STUDY_DIRECTOR
Hospital General de México Dr. Eduardo Liceaga
Locations
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Hospital General de Mexico Dr. Eduardo Liceaga
Mexico City, Mexico City, Mexico
Countries
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Central Contacts
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Facility Contacts
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Juan M Cano Calderón, MD
Role: backup
Juan F Zazueta Pozos, MD
Role: backup
Adán G Gallardo Rodriguez, PhD
Role: backup
Carlos Martínez Murillo, PhD
Role: backup
Irma Olarte Carrillo, PhD
Role: backup
Adolfo Martínez Tovar, PhD
Role: backup
Christian O Ramos Peñafiel, PhD
Role: backup
References
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de Moraes Hungria VT, Martinez-Banos DM, Penafiel CR, Miguel CE, Vela-Ojeda J, Remaggi G, Duarte FB, Cao C, Cugliari MS, Santos T, Machnicki G, Fernandez M, Grings M, Ammann EM, Lin JH, Chen YW, Wong YN, Barreyro P. Multiple myeloma treatment patterns and clinical outcomes in the Latin America Haemato-Oncology (HOLA) Observational Study, 2008-2016. Br J Haematol. 2020 Feb;188(3):383-393. doi: 10.1111/bjh.16124. Epub 2019 Aug 7.
Mersin S, Geduk A, Mehtap O, Tarkun P, Unal S, Polat MG, Aygun K, Yenihayat EM, Albayrak H, Hacihanifioglu A. Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients. Turk J Haematol. 2021 Aug 25;38(3):211-217. doi: 10.4274/tjh.galenos.2021.2020.0555. Epub 2021 May 5.
Other Identifiers
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HGM1471-002/24
Identifier Type: -
Identifier Source: org_study_id
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