Clinical trial NCT06284395: Two Schemes Response in Multiple Myeloma
Official title: Bortezomib, Thalidomide, and Dexamethasone Versus Thalidomide and Dexamethasone for Response Rates in Multiple Myeloma Patients: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Response, Acute Phase
Survivorship
Keywords: Multiple Myeloma
Bortezomib
Thalidomide
Acute Phase Response
Survival
Lead sponsor: Hospital General de Mexico
Sponsor class: OTHER_GOV
First posted: 2024-02-28
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical records of patients diagnosed with multiple myeloma treated at Hospital General de México between 2020 and 2023.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Favorable Response
timeFrame: Post-induction (6 months)
measure: Time to next treatment
timeFrame: Post-induction (2 years)
Secondary outcomes:
measure: Overall survival
timeFrame: 3000 days
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital General de Mexico Dr. Eduardo Liceaga
state: Cdmx
Study officials:
affiliation: Hospital General de México Dr. Eduardo Liceaga
name: Adolfo O Martinez Tovar, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.