Two Schemes Response in Multiple Myeloma

NCT ID: NCT06284395

Last Updated: 2024-10-02

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-20

Study Completion Date

2024-10-30

Brief Summary

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Retrospective study based on medical records of patients with multiple myeloma, eligible for stem cell transplantation, who received, first-line, the VTD or TD combination.

Detailed Description

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The most current treatment of multiple myeloma is based on a combination of drugs, including immunomodulators, proteasome inhibitors, etc. The VTD (bortezomib, thalidomide, and dexamethasone) and TD (thalidomide and dexamethasone) regimens are commonly used as a first-line treatment due to limited resources. The study aimed to compare the proportion of favorable responses, survival, and time to the next treatment between two different treatment approaches. The investigators designed a retrospective study based on medical records of patients with multiple myeloma, eligible for stem cell transplantation, who received, first-line, the VTD or TD combination.

Conditions

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Response, Acute Phase Survivorship

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DRUG

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

Intervention Type DRUG

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)

Intervention Type DRUG

Other Intervention Names

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Intervention Group

Eligibility Criteria

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Inclusion Criteria

* clinical records of patients who were considered eligible for transplant due to their functional status and who were given some treatment strategy comprising a combination of drugs.

Exclusion Criteria

* Incomplete clinical records
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General de Mexico

OTHER_GOV

Sponsor Role lead

Responsible Party

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Christian Omar Ramos-Peñafiel, MD, PhD

Principal investigator

Responsibility Role 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

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Christian O Ramos Peñafiel, PhD

Role: CONTACT

+52 55 27892000 ext. 2020

Adán G Gallardo Rodriguez, PhD

Role: CONTACT

+52 55 27892000 ext. 2020

Facility Contacts

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Christian O Ramos Peñafiel, PhD

Role: primary

5523351588

Adan G Gallardo Rodriguez

Role: backup

+525584005072

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.

Reference Type BACKGROUND
PMID: 31392724 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33947178 (View on PubMed)

Other Identifiers

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HGM1471-002/24

Identifier Type: -

Identifier Source: org_study_id

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