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Two Schemes Response in Multiple Myeloma

Bortezomib, Thalidomide, and Dexamethasone Versus Thalidomide and Dexamethasone for Response Rates in Multiple Myeloma Patients: a Retrospective Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06284395
Enrollment
83
Registered
2024-02-28
Start date
2023-11-20
Completion date
2024-10-30
Last updated
2024-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Response, Acute Phase, Survivorship

Keywords

Multiple Myeloma, Bortezomib, Thalidomide, Acute Phase Response, Survival

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.

Interventions

DRUGBortezomib

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)

Sponsors

Hospital General de Mexico
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Favorable ResponsePost-induction (6 months)Criteria established with the International Multiple Myeloma Working Group
Time to next treatmentPost-induction (2 years)Need for a secondline treatment after induction

Secondary

MeasureTime frameDescription
Overall survival3000 daysSurvivorship passing 3000 days

Countries

Mexico

Contacts

Primary ContactChristian O Ramos Peñafiel, PhD
leukemiachop33@gmail.com+52 55 27892000
Backup ContactAdán G Gallardo Rodriguez, PhD
nutriologo.agallardo8@gmail.com+52 55 27892000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026