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Trial Title:
Two Schemes Response in Multiple Myeloma
NCT ID:
NCT06284395
Condition:
Response, Acute Phase
Survivorship
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Acute-Phase Reaction
Bortezomib
Conditions: Keywords:
Multiple Myeloma
Bortezomib
Thalidomide
Acute Phase Response
Survival
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Bortezomib
Description:
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)
Arm group label:
Bortezomib Group
Arm group label:
Control Group
Other name:
Intervention Group
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.
Criteria for eligibility:
Study pop:
Clinical records of patients diagnosed with multiple myeloma treated at Hospital General
de México between 2020 and 2023.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital General de Mexico Dr. Eduardo Liceaga
Address:
City:
Mexico City
Zip:
06720
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Christian O Ramos Peñafiel, PhD
Phone:
5523351588
Email:
leukemiachop33@gmail.com
Contact backup:
Last name:
Adan G Gallardo Rodriguez
Phone:
+525584005072
Email:
nutriologo.agallardo8@gmail.com
Contact backup:
Last name:
Juan M Cano Calderón, MD
Contact backup:
Last name:
Juan F Zazueta Pozos, MD
Contact backup:
Last name:
Adán G Gallardo Rodriguez, PhD
Contact backup:
Last name:
Carlos Martínez Murillo, PhD
Contact backup:
Last name:
Irma Olarte Carrillo, PhD
Contact backup:
Last name:
Adolfo Martínez Tovar, PhD
Contact backup:
Last name:
Christian O Ramos Peñafiel, PhD
Start date:
November 20, 2023
Completion date:
October 30, 2024
Lead sponsor:
Agency:
Hospital General de Mexico
Agency class:
Other
Source:
Hospital General de Mexico
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06284395
